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Guide to Shop Microscope Binocular in MeCan

2021-07-19
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Does Ultrasound Scan Result Determine Due Date?
Does Ultrasound Scan Result Determine Due Date?
Ultrasounds are meant to be the main precise thank you to foretell a due day...yet this nonetheless is not right. It additionally relies upon on how early your ultrasound replaced into achieved. the quicker the ultrasound, the extra precise. ..as all little ones commence a similar length, yet as time passes, little ones strengthen at distinctive expenditures. in case you are somewhat aggravating approximately your length, communicate on your ob/gyn and ask for yet another ultrasound...with 3-d US they could assume how great your infant is at present time. additionally look ahead to swelling, you may properly be gaining water weight that's a demonstration of pre eclampsia1. What can they tell from a 2nd ultrasound scan?From doing the ultrasound, and they said that everything is fine, I would not worry, and trust in them that everything is fine and that baby is healthy, if you want to find out about Downs Syndrome or Spina Bifida, then they would have to do an amnio to find out, they would have to get fluid samples from the Amnio Sac that is surrounding the baby to determine weather the baby has Downs Syndrome or Spina Bifida2. My wife is 23 weeks pregnant and had an ultrasound scan today.Some questions?all i know is the heartbeat looks good! if the dr did not say anything then i would not worry. they would tell you then and there if something was off3. Heat felt on skin during ultrasound scan?Ultrasound uses sound waves rather than ionizing radiation cause by other imaging studies (and linked to cancer, etc). It is generally considered safe. And, yes, it causes the skin to elevated in temperature slightly and can induce a very mild inflammatory response. Most women would do not notice this, but some (like you) do. It might feel a bit warm, but definitely not "hot"...and is no harm to you or your baby. Not everybody in the world (i.e. medical orginazations) believe ultrasound to be completely safe, but it is currently considered safe enough to be standard of care in the U.S. because the benefits it brings FAR outweigh minimal (if any) risks (that is, for one dating ultrasound around 20 weeks). Having tons of ultrasounds during pregnancy is still probably safe, but not considered to be a very wise idea...especially if there is no medical reason for the ultrasound. But the warmth you felt is quite common and harmless. You can check out the link below, too...if you want more information... Hope this helps some...4. What is the meaning of the following terms from an expecting mother's recent ultrasound scan report:?all i know is hc is head circumfrence5. can a girl be mistaken for a boy in a ultrasound scan?No, While the only 100% way of knowing the gender is Amniocentesis, the image of the labia and the image of the scrotum and penis are too different looking images6. When I had my ultrasound scan the hospital policy was not to tell you the sex of the baby.?You do not really need to know the sex of the baby. You can just wait till you give birth. If you are preparing the name, you can just prepare a boy's name and a girl's name. :)7. How do i get 4D ultrasound scan?Insurance companies do not often cover these tests, so if you want to have one done you need to do it privately. Find a clinic that specializes in them and tell them you are going in as a private patient (which probably is the majority of the people they see anyways) and ask how much it would cost. If you can afford it (because I've heard they are a little expensive, do not get me wrong!) then you can schedule the appointment on your own. I would personally suggest that you do it when you are at least 20 weeks pregnant so that you can clearly make out the babies features and sex (since it may be the only one you get during the pregnancy, it would be best to get the most out of it!) Good luck, and congratulations!8. 6 weeks ultrasound scan only sac shown???I think you need to talk to your doctor. Your doctor should have actually mentioned something to you prior to this happening. You might not get serious answers on here. Some ppl will just say anything, even something dumb just to get points. CALL YOUR DOCTOR ASAP.
You Docs: Magnets Are a Revolutionary Way to Relieve Pain
You Docs: Magnets Are a Revolutionary Way to Relieve Pain
Physicians have long known that "the body electric" is for real: Tiny electrical currents and magnetic fields are constantly firing off inside you. We just haven't known how to harness these forces for healing. But a handful of scientists and medical innovators have relentlessly pursued this.They're succeeding, using something few docs know much about. It's not a new pill or operation; it's magnets. Not the kind you stick on the fridge, but pulsating electromagnets. They produce invisible energy waves that increase blood flow and normalize some electrical impulses to and in nerves. One Food and Drug Administration-approved device - yep, they're that far - relieves more than 50 per cent of post-operative pain. Nobody appreciates what a godsend that is like an anesthesiologist (Dr. Mike) and a surgeon (Dr. Oz). Well, nobody except every surgery patient who's woken up to a world of hurt. Called the Torino, this post-op pain zapper is so new that even MDs who've vaguely heard of it probably think it's a new car.How do devices that use a pulsed electromagnetic field (PEMF) relieve post-op pain and - you're about to get as excited as we are - intractable back, neck, foot and arthritis pain? Your nerves, cartilage, spinal fluid, bones, muscles and blood all rely on a symphony of dancing ions. PEMFs activate these electrically charged particles in ways that seem to turn off inflammation and turn on cell repair.PEMFs rev up production of nitric oxide, which increases blood flow to the targeted area. The combo stimulates an anti-inflammatory cascade that, in the Torino's case, not only halves post-op pain but also reduces swelling and speeds healing.PEMF therapy also coaxes badly broken bones to mend that otherwise might not. When you break something, electrical "injury" currents rush through your bone, signalling instructions for knitting it back together. But in nasty breaks, that process short-circuits. To re-create the currents, surgeons implant electrodes into mangled bones. Not much fun, plus you look like Frankenstein. Enter PEMF mats, bandages and knee braces, which stimulate healing currents. Aim PEMFs at the damaged zone for eight to 30 minutes, two to four times a day, and you'll heal better, faster. Side effects? Zero, at least in the short term. The products are still too new to know whether there are long-term issues. (Full disclosure! Dr. Oz has no financial interest in any PEMF companies. Neither does Dr. Mike, but he's so excited about its medical potential that he may invest in one.) So why hasn't your doc even mentioned PEMF? Three reasons:1.Docs are repelled by "medical magnet" charlatans selling bracelets, migraine goggles and shoe inserts, which are as healing as sugar cubes.2.Few physicians know a thing about how cells, nitric oxide and inflammation are affected by PEMF.3.It takes so much time and money to prove medical devices are safe and effective that only two PEMF gizmos have earned FDA approval so far. Since neither is owned by a drug company with mega advertising bucks, your doc likely hasn't heard a word about them.What does PEMF feel like? "Nothing," says one person who has "tried everything" for back pain. "You don't feel anything. Except immediately better." What if you or someone you love wants to try PEMF for pain that won't quit?• Consider only devices that use pulsed electromagnetic fields.• For your convenience, a list of PEMF products and info about them, including a knee brace for arthritis and a body mat for back pain, are on www.DoctorOz.com The YOU Docs, Mehmet Oz, host of "The Dr. Oz Show" and Mike Roizen of Cleveland Clinic, are authors of "YOU: Losing Weight." For more information go to www.RealAge.com 2011 Michael Roizen, M.D. and Mehmet Oz, M.D.Distributed by King Features Syndicate, Inc.
How Do I Get 4D Ultrasound Scan?
How Do I Get 4D Ultrasound Scan?
All you have to do is search for 4D ultrasound in your area on Google. Then call and make the appointment. it is not covered by insurance and you will have to pay for it, but when we did it, we paid only like $175 and we got great pictures to take home of the 3D scan (8 total) and a DVD of the live action (which is what the 4D is) and we get a discount when we go back. You may want to wait until your further along (20 wks plus) and you will drink a lot of water for 1-2weeks before hand. It's not hard to schedule and get done at all. Hope that helps!1. What can they tell from a 2nd ultrasound scan?most of the time only a quad screen or similar test can detect those, which is why i got one even though im only 192. How to convert a Voluson 4D ultrasound scan (.V00 file) to a video?Assuming you've exported a Voluson file without compression enabled (Wavelet = 'Off') and with the Volume/Raw File selected... try using this script to see if your data is in third-party DICOM format. This does not reconstruct the data into a useable format but does show if you can access the element data.3. hi ive been told in my ultrasound scan that im expecting a baby boy.they could see the testicles and penis?I had two boys, so yes, I had the same answer with the ultrasound. If they can clearly see the penis and testicles, there's not much room for discussion. Just as a really clear picture of a girls genitalia is unmistakable. That being said, those scans are not 100% accurate. Just keep an open mind. lol If its not a crystal clear shot of the genitalia, then its possible that an arm strategically placed between the legs was mistaken for male genitalia4. How accurate is an ultrasound scan for determining number of pups expected at 7.5 weeks (53days) pregnant?a few years ago we rescued a pregnant lab. she never really looked pregnant. I thought one or 2 pups. She had 9 all very healthy, beautiful pups. I would think if there was only one pup that she would barely show. most pregnancies do not become apparent to the eye before about 5-6 weeks along. It is very unusual for one to start showing at 3 1/2 weeks. I bet there are more pups than one, or she may be carrying some dead ones.5. My wife is 23 weeks pregnant and had an ultrasound scan today.Some questions?What did the dr say about these things! Why did not you ask them if you were worried. If your dr did not say they were bad, why are you asking us as if we are doctors! All look good to me!6. What is the meaning of the following terms from an expecting mother's recent ultrasound scan report:?visit this link i hope it was help you.7. Why do my 2 ultrasound scan show 2 different weeks?Slow down here and take a breath! Why would you think that a few days difference is going to make you lose anything? Its OK for your due date to vary by a few days this early on and its even OK for it to vary by up to 14 days later on. Its an average of 40 weeks with the understanding you *could* go 2 weeks early or 2 weeks later than those 40 weeks. Do not worry about your due date until you have too. You posting stressful questions such as this will do more harm to a pregnancy than being off by a few days which is common8. If baby is positioned at back of uterus can it be missed on ultrasound scan in the second trimester?No. Except in the first few weeks of pregnancy , the baby can never be missed on ultrasound . In the second trimester , no chance . The scan sees right up to the posterior end of the uterus . If in such doubt , rethink your diagnosis . Good luck !9. 6 weeks ultrasound scan only sac shown???Does not sound like a viable pregnancy but if you had the US I guess your doctor already told you this? Have you had your thyroid checked to see if it's out of whack? 14 MC's is way more than "normal", good luck. Get your thyroid checked
How Early Can a Pregnancy Be Seen on an Ultrasound Scan?
How Early Can a Pregnancy Be Seen on an Ultrasound Scan?
about 6-7 weeks is the earliest you can se anything, with an internal ultrasound1. how soon can you tell the sex of your baby with a 3d 4d ultrasound scan?i think you will need to wait a bit longer. i just found out at 15wks 4 days that i am having a little boy and it was definately clear and it wasnt a 3d/4d scan either. so i would say within a month you should probably be able to find out.2. Does Ultrasound Scan result determine Due date?Ultrasounds are meant to be the main precise thank you to foretell a due day...yet this nevertheless is not maximum suitable. It additionally relies upon on how early your ultrasound become finished. the faster the ultrasound, the extra precise...as all toddlers start up a similar length, yet as time passes, toddlers improve at different expenditures. while you are somewhat nerve-racking approximately your length, talk on your ob/gyn and ask for yet another ultrasound. ..with 3-D US they could are looking forward to how super your toddler is on the instant time. additionally look ahead to swelling, you are gaining water weight that's an illustration of pre eclampsia3. My baby's gender??? Ultrasound scan???!!!?Hah. You said 5 weeks in the first line and I thought your ultrasound technician must be INSANE!! But now that I see it's actually 15 weeks, then I would say there's a good chance she is correct. If she got a really great view, then she probably would have been able to see the "boy parts" forming. However, 14-15 weeks is still a little too soon, so I would not go out buying pink until you get it confirmed at 18-20 weeks!.4. hi ive been told in my ultrasound scan that im expecting a baby boy.they could see the testicles and penis?i went for my 4 month check-up & my ultrasounds showed the baby's penis & testes...i saw 4 myself as well...5. My wife is 23 weeks pregnant and had an ultrasound scan today.Some questions?If there was a major immediate concern, the tech would have set you up to see somebody about it right away - so do not worry about that. I do not know about all of those specific stats, but I will tell you what I DO know. The heartbeat is fine...the norm can be from 120 to 170. 475 grams is about 1.05 lbs which is fine. Liquor means amniotic fluid, and 18 is a good number (it should be between 5 and 24). That is all I can tell you about. Your doctor will most likely go over the ultrasound results with you at some point (even when they are normal) and you can ask him/her more specific questions at that time.6. When I had my ultrasound scan the hospital policy was not to tell you the sex of the baby.?I would question whether or not you want to have your baby at a hospital like this. I have never heard of such a thing!7. What can they tell from a 2nd ultrasound scan?they test that through bloodwork....meaning the baby's. so they get amniotic fluid or cord blood...very invasive but optional8. What is the meaning of the following terms from an expecting mother's recent ultrasound scan report:?I would call the hospital or your doctor for an explanation of what you do not understand from the ultrasound report, they have the experience and the expertise to tell you what this all means9. What does it mean that my wife's twins have different gestational ages? She is currently pregnant with twins, and on each ultrasound scan it is shown that one is a week older than the other. When I ask doctors they themselves are baffled.Gestational age is age in gestational weeks determined by measures of fetus which most fetuses (or in average) develop in that week of pregnancy.It could be that one twin develops a little bit faster than the other. Or that one is concieved qnd implanted a few days after than the other. I do not know if difference in one week is significant - it does not have to mean anything particular. -> You need to ask the doctor about that, if it is anything important, and which could be the reasons.Try to relax; enjoy pregnancy with your wife.
U.S. Regulators Snip Red Tape for Medical Devices to Curb Opioid Crisis
U.S. Regulators Snip Red Tape for Medical Devices to Curb Opioid Crisis
(Reuters) - Laura Perryman expected her medical company, Stimwave Technologies Inc, would have to wait several years for its painkilling device to win U.S. approval as a treatment for chronic migraines.She now thinks it could be done in months, thanks to a new initiative by the U.S. Food and Drug Administration to use medical device-based treatments, diagnostic tests and mobile medical apps to address the country's opioid crisis.When President Donald Trump declared a public health emergency over the abuse of heavy-duty painkillers like oxycodone and hydrocodone, he ordered all government agencies to take action in response to the death of 70,000 Americans last year from drug overdoses.The FDA told Reuters it has received over 200 submissions from companies seeking a speedy approval process for their devices. These range from Stimwave's Halo to painkilling products made by Abbott Laboratories and other industry heavyweights as an alternative to opioids."We're pleased by the robust interest in this innovation challenge and the acknowledgement from developers about the unique and important role medical devices, including digital health technologies like mobile medical apps, have the potential to play in tackling the opioid crisis," FDA Commissioner Scott Gottlieb said.Perryman's Halo devices, which look like angel hair pasta and are so small they can be injected into a nerve, took four years to get U.S. approval under other names for easing leg and back pain.She hopes a spot on the FDA program will see Halo approved within a year as an alternative to opioids, which are currently used to treat an estimated 50 percent of patients who come to emergency rooms with migraines."This is kind of perfect for something like ours...since the device is shown to be safe already," said Perryman, who founded privately-held Stimwave in South Florida seven years ago.The FDA has been increasingly reluctant to greenlight new opioids for market but earlier this month approved a potent opioid-based painkiller from AcelRx Pharmaceuticals Inc placing tight restrictions on its distribution and use. In a rare move, Gottlieb made a public statement at the time, explaining the decision.The regulator's push for alternatives to opioids has helped drive interest from venture capital funds and institutional investors this year in firms promising to develop alternatives, according to interviews with device companies, financial services firms and brokerage Cowen & Co.For example, privately-held Virpax Pharmaceuticals, which makes an aerosol spray that delivers a non-opioid pain drug, said it had four or five banks interested in running its Series A investment round this summer versus just one in the past.Abbott, like rivals Boston Scientific Corp and Nevro Corp, makes neuromodulation implants which stimulate the nervous system to mask pain signals before they reach the brain.Abbott has submitted an entry for the competition in the hope it will slash waiting times, which often stretch several months just to get an initial meeting, according to Dr. Allen Burton, Abbott's medical director of neuromodulation."Devices that are part of this (program) will be streamlined... their meeting will go to the top of the pile," said Burton.While neuromodulation is only a small part of Abbott's large medical device business, the unit is seen as a growth engine for the company. Burton estimates between 10-to-20 percent of the growth Abbott has seen in its neuromodulation business could be tied to doctors prescribing its devices for pain after surgery or from injury to patients that are opioid averse.Boston Scientific did not apply for the contest, but the company is investing "heavily" in its neuromodulation unit, which was its fastest-growing at nearly 23 percent in the latest quarter, according to Maulik Nanavaty, senior vice president at the device maker."We continue to make external investments in early (neuromodulation) technology," he told Reuters.To be sure, these devices are not seen as a silver bullet for opioid addiction. Nirad Jain, a partner at consulting firm Bain & Co, believes many of the solutions on the table are just tinkering at the edges of a problem that needs to be solved by doctors simply settling for fewer or less potent opioids.Academics and charitable groups dealing with the social fallout of the crisis say the bulk of the rise in deaths stems from misuse of prescription painkillers. That has put the onus on regulators in September to issue new rules cracking down on prescribing by doctors."The goal is that these guidelines will provide evidence-based information on the proper number of opioid doses that should be dispensed," Gottlieb said in a statement at the time."Our goal is to help prevent patients from becoming addicted by decreasing unnecessary or inappropriate exposure to opioids." Although the FDA contest is limited to devices and app-based solutions for pain and addiction, the current regulatory climate is also conducive to companies developing opioid-alternative pharmaceuticals.Drugmakers including Pfizer Inc, Eli Lilly and Co, Regeneron Pharmaceuticals Inc and Teva Pharmaceutical Industries Inc have been packing their pipelines with potential solutions to the crisis and there are 120 non-opioid drugs under FDA review this year, up some 650 percent since 2013, according to business intelligence firm Informa.(Non-opioid drug applications surge png, tmsnrt.rs/2ReUI2H Privately-held SPR Therapeutics Inc told Reuters it has entered its "temporary" neuromodulation device in the contest. Similarly to Stimwave's, its product is implanted into the body but can be surgically removed after about two months. Josh Boggs, a senior executive at the company, expects to get quicker feedback from the FDA and shorter review times in the wake of the crisis.After years in the business, he believes the crisis has increased the agency's desire to collaborate with medical technology companies like his."I feel like (FDA) people are coming well prepared to meetings and are very engaged in it. It feels like an atmosphere that's conducive to finding a solution," he said.(The story corrects third paragraph to say the deaths were from drug overdoses, not specifically opioid overdoses)
Hand Held Ultrasound Machine for Pregnancy Testing
Hand Held Ultrasound Machine for Pregnancy Testing
Pregnancy and Intimate Partner Violenceby Professor Jenny Gamble and Dr Kathleen BairdBeing pregnant offers no protection from intimate partner violence (IPV). Up to 30% of women first experience IPV during pregnancy, probably because they are more reliant on their partner for support and are therefore more vulnerable. Over 400,000 Australian women report IPV in pregnancy. Males who are violent toward their pregnant partners have few moral boundaries. They are more likely to use increasing force in the attacks, placing their partners at increased risk of homicide. The unborn baby is at significant risk as perpetrators often target blows to the abdomen — a strategy that increases both fear and control. Children suffering from the incidences and impacts of domestic and family violence are not only known to be socially and academically disadvantaged over the long term, but are also more likely to become distrusting of adults, with 1 in 5 developing antisocial behaviours such as aggression and violence.White Ribbon Day raises community awareness about the need for a range of preventative measures and responses to domestic violence, it can also be observed that health professionals such as midwives have been underutilised and have the potential to play a key role in both preventing and responding to violence.Not being asked about violenceWe know that many women are reluctant to disclose their experience of violence for fear of:not being believed,being judged and stigmatised,the risk of having children removed, orsimply because she may think nothing useful can be done about her situation. Women want to be asked about IPV during pregnancy and can feel let down if they are not given an opportunity to disclose their experience of violence.In our research, one woman commented about the failure to ask about IPV saying,"No, the midwife did not ask me about domestic violence and I found it really hard to talk to her. …. I was thinking I should tell the midwife, but I did not know how to bring it up. … if the midwife had asked me, or I knew the midwife better, I might have told her".Another woman talked about feeling alone and wishing the midwife had asked her about IPV saying,"The midwife never actually asked me and I wish they had and offered me some help. You feel you are the only person living with violence …"It seems unreasonable to expect a woman to willingly disclose abuse to health professionals in our fragmented maternity care system, where they traverse maternity services and experience a different health professional at almost every encounter. Transforming maternity services: Relationship-based careWhile midwives could play a much greater role in asking women about abuse, offering an initial response and facilitating access to other services, this is much more likely to be effective if we remodel the delivery of maternity services.High quality evidence from 15 randomised controlled trials and over 17,000 participants show that women and their babies fare better when they are provided with their own midwife throughout pregnancy, labour and birth and up to at least 6 weeks after birth.In a 2015 update of a Cochrane systematic review demonstrated:a reduction in preterm birth,lower rates of death for babies,higher rates of normal birth, andlower rates of intervention in labour for women provided with continuity of midwifery care. Outcomes were improved, or were no worse, for every outcome measured. This model of service delivery also costs less than the current system for providing maternity services and women prefer it.Other research indicates that midwives offering continuity of care experience lower rates of stress and work related burn out. There increasingly high quality and robust evidence to support the provision of women with a continuity of midwifery care than for just about any other health care intervention. Despite this overwhelming evidence, less that 8% of Australian women have access to this model.We also know that women experiencing violence or at an increased risk of violence are much more likely to disclose to a trusted person. Trust develops through relationships. Our professional experience in providing continuity of care is that women will make contact again at different times in their life, sometimes years later.In continuity of care relationships, women have a person to turn to — a trusted, knowledgeable person to share sensitive information with and not feel judged.Changing the model of maternity service delivery so that each woman has her own assigned midwife (with back-up midwife) would enable her to establish a close relationship with one or both healthcare professionals. Basing midwives in the community, co-located with other community services providing home visits during pregnancy and after birth, accompanying the woman to the hospital or centre for the birth has significant potential to meaningfully address intimate partner violence.Midwives are welcomed into homes and can engage with families in ways that many other professionals can not . This relationship has the potential to provide safe opportunities for disclosure and to offer support, including referral to expert agencies that work in the community. What about primary prevention?Primary prevention strategies seek to remove the causes of violence, to prevent the development of risk factors associated with violence, and/or to enhance the factors protective against violence.Prevention strategies midwives could implement include:providing general information,skills training in respectful couple relationships,community development to grow a network of women to foster adequate general social support.assisting the couple with their transition to parenthood and parenting which we know is protective against violence. Midwives can support women to identify their needs and help them set their expectations of support. The midwife can assist and support a woman in understanding attitudes and social norms that support violence, enable her to identify disrespectful behaviours, as well as communicate the standard of respect required in an intimate relationship. Importantly, the midwife is in a prime position to assess the level of partner support and to witness controlling behaviour and couple conflict. As one woman attending the intimate partner violence summit commented,"It probably seems simplistic but it's really important to raise awareness and increase people's knowledge about the issues, because the bottom line is if a person does not see that there's a problem, they are never going to do anything.".This applies to the whole community.The cultural change needed to prevent violence, as with other complex health and social issues, requires a multidisciplinary approach involving reinforcing strategies implemented with individuals, families, organisations and communities. It is important that midwives are integrated into such a response using relationship-based continuity of midwifery care model of maternity service delivery. Listen to Rachel Kayrooz, a former victim of domestic violence while pregnant, and Dr Kathleen Baird, talk about the need for training for midwives in handling cases of domestic violence.ABOUT THE AUTHORSProfessor Jenny GambleProfessor Gamble is Head of Midwifery at Griffith University. She is internationally recognised professional leader and researcher into models of maternity care and perinatal mental health. She is a strong advocate for women-centred of care, and humanising and de-medicalising care.She has authored over 100 peer-reviewed published papers and several book chapters. As Head of Midwifery she developed an award winning innovative Bachelor of Midwifery program, and developed a high quality academic team with depth and breadth of clinical expertise. She pioneered continuity of midwifery care in Queensland when she established a private midwifery practice. She was the first midwife to gain visiting rights to a Queensland hospital (1992).She was honoured with a Churchill Fellowship in 2007 in recognition of her commitment to quality maternity care and supporting transition to motherhood for socially disadvantaged and vulnerable women. Her life's work has been aimed at reforming maternity services and developing the capacity of midwives to respond to childbearing women's needs.Dr Kathleen BairdDr Baird is a Senior Midwifery Lecturer at the School of Nursing and Midwifery, Griffith University and Director of Midwifery and Nursing Education, Women's and Newborn Service, Gold Coast University Hospital.For the last fifteen years Kathleen has researched intimate partner violence, with a focus on violence during pregnancy. Her PhD explored women's experiences of partner violence during pregnancy, birth and the postnatal period. Kathleen has been involved with domestic violence training of health professionals, undergraduate and postgraduate health students and members of the voluntary services for several years. Kathleen is currently involved with several research projects in relation to intimate partner violence and the role of health care and has recently been invited to join the Queensland Domestic and Family Violence Prevention Council. Return to the Machinery of Government.
Fda Approval of Medical Devices Involves Shockingly Little Research
Fda Approval of Medical Devices Involves Shockingly Little Research
Are federal regulators playing fast and loose with the health of the tens of millions of Americans who rely on medical devices to see, walk and survive?That's the suggestion of a new study that finds most medical devices go to market with little evidence that they work or are safe.Groups like Consumer Reports and the Government Accountability Office have long criticized the U.S. Food and Drug Administration for approving medical devices that end up killing thousands of people a year . They've been most critical of the fact that the FDA allows 99 percent of new devices to go to market without any new clinical testing whatsoever.But a team at the Yale School of Medicine found that even the 1 percent of devices that are studied before getting FDA approval likely aren't being studied enough.This 1 percent consists of so-called "high-risk" devices, which are very different from any others on the market and which are implanted within the body or directly support human life. The Yale researchers found that these devices are subjected to an average of just one major study apiece before being granted FDA approval. This means that doctors are implanting devices like coronary stents, replacement hips and intraocular lenses in thousands of patients after they've been tested on groups of just a couple hundred people each.Dr. Joseph Ross, a professor at Yale School of Medicine and one of the authors of the paper, said that this state of affairs is the result of federal legislation stipulating that the FDA can only require manufacturers to do the bare minimum amount of research to demonstrate the efficacy and safety of a new medical device."The laws are written in a way to facilitate earlier access to therapy, because that's what most lawmakers think their constituents want," Ross said. "But as a result, we don't have the data we need to make the best decisions for our patients." For their study, Ross and his co-authors looked at the 28 high-risk devices approved by the FDA in 2010 and 2011. They found that, on average, each device was the subject of just two studies before getting FDA approval, and that in most cases, one of the two studies wasfocused more on the basic mechanics of the device than on its long-term clinical effects.As a condition of its approval, the FDA did stipulate that manufacturers would have to carry out further studies of the effects of these devices after their release. The FDA called for 33 such studies in all, among the 28 devices approved in that period -- a little more than one additional study per device. But the research team found that just six of these 33 studies have been completed so far, five years after some of the devices were released. Moreover, many of the clinical trials that have been completed failed to compare the medical device in question with any other medical device.Though none of the 28 devices have been implicated in the death of any patients, one of them -- a stent used in the treatment of brain aneurysms -- was voluntarily recalled because of a flaw that the FDA said could have been deadly . And more than 6,000 of the 150,000 patients who have been implanted with another device, DePuy's Pinnacle Complete prosthetic hip system, have sued the manufacturer , claiming that the metal-on-metal device caused pain and leached harmful metal ions into their bloodstreams.Ross said that there are no protocols in place to identify patients using any given medical device, so it's impossible to say exactly how many of a particular device are currently being used, or to monitor their impact in a rigorous way."Right now, medical devices, unlike your computer, or your television, or even a box of pens you would buy -- they don't have a bar code on them," he said. "So we can't track devices once they leave the manufacturer." This, at least, is changing. A law mandating identification numbers for all medical devices will be phased into effect starting in 2016 But Ross warned that the 21st Century Cures Act, a major scientific research bill passed overwhelmingly by the House of Representatives last month and currently under consideration by the Senate,could make the FDA's already low threshold for approval of new medical devices even lower."There are a lot of measures aimed at FDA deregulation in the bill," Ross said. "It's minimizing their ability to impose stricter evidentiary standards prior to approval for lots of products, including medical devices." UPDATE:8/18, 6:20 p.m. -- In an email to The Huffington Post Tuesday, the FDA noted that "some FDA mandated post-approval studies are longer than the three to five year observation period in the study," and that "therefore the studies may not be expected to be completed." The agency also noted that it "uses a variety of other data sources and methods to monitor the safety and effectiveness of marketed medical devices." "These can include medical device reports (MDRs) of adverse events and product problems, device registries, review of scientific literature, and other approaches depending on the specific device and public health need," the FDA said in its email.If you or someone you know has suffered adverse consequences as a result of a high-risk medical device, The Huffington Post wants to know. Please contact the author of this story at .
Dr Chantara Thevy Ratnam: Polymer Power
Dr Chantara Thevy Ratnam: Polymer Power
Meet the first Malaysian to win the Grand Prix Award at the 34th International Exhibition of Inventions, New Techniques and Products.Doing experiments. Generating data. And solving a million problems we didn't even know existed.Being a nuclear scientist doesn't mean you make bombs, though it's a question Chantara gets asked a lot.On the contrary, her work at the Malaysian Nuclear Agency involves the radiation processing of polymers - large molecules made up of sub-units connected to each other by chemical bonds.A polymer can be anything from DNA to rubber, although most often the word is used to refer to plastics.One such plastic Chantara invented, a radiation-sterilisable PVC compound, won her a Grand Prix Award at the 34th International Exhibition of Inventions, New Techniques and Products in Geneva, Switzerland, back in 2006.Being the first Malaysian to win this prestigious prize has been highly motivating.Her invention doesn't exactly roll off the tongue, but it holds great promise in the manufacture of medical devices.Currently, many types of medical devices are sterilised using ethylene oxide (ETO) gas, a toxic compound known to have some nasty side effects.A potential environmental contaminant associated with a range of health hazards, ETO is also listed as a probable carcinogen.So the world has been exploring radiation as an alternative sterilising agent.The problem is, irradiated plastic medical devices tend to go yellow and deteriorate faster.Chantara's special PVC compound doesn't.She says it could be used to manufacture blood transfusion tubing, intravenous tubes and kidney dialysis equipment.Currently, Chantara's team is applying for funds to conduct pre-clinical trials and toxicity studies.Once that's done, the intention is to partner up with industry players who will use the compound to manufacture medical devices, which will then be tested on patients in hospitals.It sounds like a small innovation, but in the greater scheme of things - particularly Malaysia's ambitions to become a competitive hub for the biomedical industry - it's a worthy contribution.Rubbery reincarnation Chantara's other notable innovation involves scrap rubber.Malaysia exported RM14.62bil worth of rubber products last year - just think of the piles of rejects and waste.And then there are tyres. It's estimated Malaysia will generate 311,337 tonnes of scrap tyres on the peninsula alone next year.Most of this scrap is disposed of via unknown routes, with many ending up as water collection points for disease-carrying mosquitoes to breed.The puzzle Chantara has been trying to solve is: how can we give scrap rubber a new lease of life?Usually, low-value waste rubber is pooled, melted, and chemically treated for re-use. The recycled rubber is of a much lower quality, with reduced tensile strength, so it tends to be used for lower-grade products such as slipper soles.It took Chantara six years to develop a patented formula which can be mixed in during the "compounding" stage of rubber processing.*Compounding is the stage at which rubber scraps are melted and chemicals added to facilitate the breakdown of the molecular bonds, before products are reformed through processes like extrusion and injection moulding," she explained.The entire process is free of hazardous emissions and chemicals, according to Chantara. The quality and tensile strength of the treated rubber makes it suitable for products like O-rings, gaskets, hoses, bumpers and diaphragms.The agency is working with local industry partners on the pre-commercialisation phase of the technology. It has applied for government funding to scale up production of the patented chemical compound, for pilot production on an industrial scale.Eventually, Chantara hopes, the technology will become available in the market via licensing of Nuclear Malaysia's patented formulation.The only potential snag might be the logistics of commercialisation; which is why industrial partnerships and government are such important parts of the equation.Scientists constantly innovate, but an entire ecosystem is needed to translate their work into applications that benefit the general public.Dr Chantara Thevy Ratnam Current job title:Senior Research Officer/Manager, Polymer Blends and Composites Group, Radiation Processing Technology Division, Malaysian Nuclear Agency (Nuclear Malaysia,) Bangi Likes:Hard-working people Dislikes:Jealousy Favourite song:Daddy Cool (Boney M) Childhood ambition:Medical Doctor Grew up in:Bahau, Negri Sembilan Favourite food:Banana leaf rice (vegetarian) If you were a plastic, what type would you be and why?Cheap, strong, durable, transparent, versatile, biodegradable, non-toxic. Because it will be very useful in the healthcare industry, cost-effective and environment friendly.You are transported to a desert island and only get to take three items with you, what are they?Fire (matches/lighter), KA-BAR knife, water.Related stories:Brains for progress: Scientists are changing the world Dr Luqman Chuah Abdullah: Driven to innovater Prof Dr Raja Noor Zaliha: Adventures in microbe hunting
Ultrasound Machine for Home Use
Ultrasound Machine for Home Use
Ultrasound machines are used in many different fields. They are used in hospitals, clinics and veterinarians. But they are also used for home use where they can be bought for as low as $500.The main advantage of ultrasound machines is that you can do everything that a medical assistant could do, except that it is much faster and quieter. You can do more things with them than with a medical assistant who would have to get into the patient's room and perform the same tasks over and over again.The main disadvantage of ultrasound machines is their size - they are too small to accommodate your hand during examinations, so you need special equipment to fit your hand inside the machine.To cut down on size issues, some people created ultrasound machines which have a long narrow body which makes it easier forWhat did homes used to smell like?My childhood home smelled of cigarettes and flatulence, dad was a heavy smoker and a world class farterWhat is the best flat iron out there?Chi is good, but very overpriced, unless you are a professional hair stylist. Some are $200 but they are definitely not for home use. Hot Tools and Herstyler are also great products, and not too expensive. I would say that you will spend between $50-$75. However, my sister got the Herstyler on Ebay for $40. BTW, some will advertise that they "protect" the hair from damage. But the bottom line is that when we use heat in any form on our hair, it's damagingWhat're the different drinks I can concoct at home using Baileys?If you have butterscotch schnapps and milk you can make a butter finger I just do like a shot of butterscotch and a shot of baileys and the rest milk, coffee and baileys is good but personally I love baileys on the rockshow to earn at home using internet (other than online trading)?You have to invest some money. You are already investing your time and money with your computer. You can sell items like mobile phones, jewelery, garments etc. Considering an IP security camera for home use. Need advice?They do not need any software they can just plug strait into a network input on your broadband modem, they usually have 4 network ports, well one camera can, if you want more then you have to plug them into a piece of hardware on your computer and use that to control which camera you watch, it's all done with hardware. There will be a free secure browser software included which you would need to install on your phone and would need to be a version that works with your phone to control multi camera installations, but with just one camera you do not even need that. There is one thing you should know and that is you need a constant, fixed IP Address from your ISP (Internet Service Provider), normally it changes every time you connect to broadband, but it needs to fixed so that typing the address into the browser on your phone will connect to your modem and through that to the camera. (the IP address will be something like XXX.XXX.XXX.1 to 4) all numbers. Some ISP's charge extra for this, but with any of the smaller ones it's included, but will need activating on their server. ChrisCan I do a colonic at home using a douche?I have a very old medical book here dating back to 1800! They show graphic pictures of colonic irrigation, using a long rubber tube which is inserted good four feet up the anus. That is attached to a glass bottle of water, held 3 feet up on a bottle stand and the Patient is sideways. So the height causes the water to run down the tube into you know where and the pressure inside you know where causes the feces to run out all over the place! A douche will not hold the right amount of liquid and unlike the colonic irrigation places, you have no vacuum system. Best of Luck.Can a veteran buy a home using VA loan with bad credit?You do not specify what you consider "bad," but the credit standards for VA loans are quite forgiving. Although VA does not have a specified minimum for approval, most companies allow a FICO score as low as 580. The rate for someone with a 580 score will be about . 625% higher than for someone with a 740 score.In order to have a score of 580, there must be some combination of the following reported on the credit report:Recent history (within 2 years) of late paymentsAccounts that are currently delinquent or in collectionPublic record items: liens, judgments, bankruptcy or foreclosureHigh or over-limit credit card balances. By "high," I mean significantly over 30% of the credit limit. Some of these items would have to be resolved before any lender will fund a loan. Collection accounts will have to be settled in some manner. Currently delinquent accounts will have to be brought current. Liens and judgments will have to be paid, although tax liens can subordinate to a new first mortgage without being paid off. The borrower would have to have an installment agreement with the taxing authority, however.Ironically, almost any of these necessary actions will raise the credit scores-in some cases, dramatically. I hope this is helpfu.
Spinal-cord Stimulators Help Some Patients, Injure Others
Spinal-cord Stimulators Help Some Patients, Injure Others
Columbia, South Carolina (AP) -- Desperate for relief after years of agony, Jim Taft listened intently as his pain management doctor described a medical device that could change his life.It wouldn't fix the nerve damage in his mangled right arm, Taft and his wife recalled the doctor saying, but a spinal-cord stimulator would cloak his pain, making him "good as new." Taft's stimulator failed soon after it was surgically implanted. After an operation to repair it, he said, the device shocked him so many times that he couldn't sleep and even fell down a flight of stairs. Today, the 45-year-old Taft is virtually paralyzed, a prisoner in his own bed, barely able to get to the bathroom by himself."I thought I would have a wonderful life," Taft said. "But look at me." For years, medical device companies and doctors have touted spinal-cord stimulators as a panacea for millions of patients suffering from a wide range of pain disorders, making them one of the fastest-growing products in the $400 billion medical device industry. Companies and doctors aggressively push them as a safe antidote to the deadly opioid crisis in the U.S. and as a treatment for an aging population in need of chronic pain relief.But the stimulators - devices that use electrical currents to block pain signals before they reach the brain - are more dangerous than many patients know, an Associated Press investigation found. They account for the third-highest number of medical device injury reports to the U.S. Food and Drug Administration, with more than 80,000 incidents flagged since2008.Patients report that they have been shocked or burned or have suffered spinal-cord nerve damage ranging from muscle weakness to paraplegia, FDA data shows. Among the 4,000 types of devices tracked by the FDA, only metal hip replacements and insulin pumps have logged more injury reports.The FDA data contains more than 500 reports of people with spinal-cord stimulators who died, but details are scant, making it difficult to determine if the deaths were related to the stimulator or implant surgery.Medical device manufacturers insist spinal-cord stimulators are safe - some 60,000 are implanted annually - and doctors who specialize in these surgeries say they have helped reduce pain for many of their patients.Most of these devices have been approved by the FDA with little clinical testing, however, and the agency's data shows that spinal-cord stimulators have a disproportionately higher number of injuries compared to hip implants, which are far more plentiful.The AP reported on spinal stimulators as part of a nearly yearlong joint investigation of the global medical devices industry that included NBC, the International Consortium of Investigative Journalists and more than 50 other media partners around the world. Reporters collected and analyzed millions of medical records, recall notices and other product safety warnings, in addition to interviewing doctors, patients, researchers and company whistleblowers.The media partners found that, across all types of medical devices, more than 1.7 million injuries and nearly 83,000 deaths were reported to the FDA over the last decade.The investigation also found that the FDA - considered by other countries to be the gold standard in medical device oversight - puts people at risk by pushing devices through an abbreviated approval process, then responds slowly when it comes to forcing companies to correct sometimes life-threatening products.Devices are rarely pulled from the market, even when major problems emerge. And the FDA does not disclose how many devices are implanted in the U.S. each year - critical information that could be used to calculate success and failure rates.The FDA acknowledges its data has limitations, including mistakes, omissions and under-reporting that can make it difficult to determine whether a device directly caused an injury or death. But it rejects any suggestion of failed oversight."There are over 190,000 different devices on the U.S. market. We approve or clear about a dozen new or modified devices every single business day," Dr. Jeffrey Shuren, the FDA's medical device director said at an industry conference in May. "The few devices that get attention at any time in the press is fewer than the devices we may put on the market in a single business day. That to me doesn't say that the system is failing. It's remarkable that the system is working as it does." In response to reporters' questions, the FDA said last week that it was taking new action to create "a more robust medical device safety net for patients through better data." ''Unfortunately, the FDA cannot always know the full extent of the benefits and risks of a device before it reaches the market," the agency said. In the last 50 years, the medical device industry has revolutionized treatment for some of the deadliest scourges of modern medicine, introducing devices to treat or diagnose heart disease, cancer and diabetes.Pete Corby, who injured his back working as a movie stuntman, said a spinal-cord stimulator helped him deal with his constant pain and stop using the opioids he'd become dependent on."This is the greatest thing that saved my life, literally saved my life," said Corby, estimating that up to three-quarters of his original pain was alleviated by the stimulator.Medical device companies have "invested countless resources - both capital and human - in developing leading-edge compliance programs," said Janet Trunzo, head of technology and regulatory affairs for AdvaMed, the industry's main trade association.At the same time, medical device makers also have spent billions to try to influence regulators, hospitals and doctors.In the U.S., where drug and device manufacturers are required to disclose payments to physicians, the 10 largest medical device companies paid nearly $600 million to doctors or their hospitals last year to cover consulting fees, research and travel and entertainment expenses, according to an AP and ICIJ analysis of data from the Centers for Medicare & Medicaid Services. This figure doesn't include payments from device manufacturers like Johnson & Johnson and Allergan, which also sell other products.On top of that, lobbying records show that the top four spinal-cord stimulator manufacturers have spent more than $22 million combined since 2017 to try to influence legislation benefiting their overall business, which includes other devices.Some companies have been fined for bribing physicians, illegally promoting products for unapproved uses and paying for studies that proclaim the safety and effectiveness of their products, according to the joint investigation.In a 2016 case, Olympus Corp. of the Americas, the largest U.S. distributor of endoscopes and related medical equipment, agreed to pay $623.2 million "to resolve criminal charges and civil claims relating to a scheme to pay kickbacks to doctors and hospitals," according to the U.S. Justice Department. Olympus said that it "agreed to make various improvements to its compliance program." In a case the previous year involving spinal-cord stimulators, Medtronic Inc. agreed to pay $2.8 million to settle Justice Department claims that the company had harmed patients and defrauded federal health care programs by providing physicians "powerful" financial inducements that turned them into "salesmen" for costly procedures. Medtronic denied wrongdoing. "As a matter of policy, Medtronic does not comment on specific litigation," the company said in a statement. "We do stand behind the safety and efficacy of our Spinal Cord Stimulators and the strong benefits this technology provides to patients, many of whom have tried all other therapy options to no benefit." Some doctors enthusiastically promote spinal-cord stimulators without disclosing to patients they've received money from medical device manufacturers. Some experts say doctors are not legally required to disclose such payments, but they have an ethical obligation to do so. Sometimes the money goes to the doctors' hospitals, and not directly to them.As for Taft, he said he just wanted to get better, but he has lost hope."This is my death sentence," Taft said, stretched out beneath his bed's wooden headboard on which he's carved the words "death row." "I'll die here," he said.___ A generation ago, tens of thousands of women were injured by the Dalkon Shield, an intrauterine device that caused life-threatening infections. Consumer advocates demanded testing and pre-market approval of medical devices to prevent deaths and injuries associated with defective products.So in 1976, Congress passed the Medical Device Amendments, a law meant to assure Americans that devices recommended by their doctors would do good and not harm."Until today, the American consumer could not be sure that a medical device used by his physician, his hospital or himself was as safe and effective as it could or should be," President Gerald Ford said when he signed the bill into law.Charged with carrying out the law, the FDA created three classes of medical devices. High-risk products like spinal-cord stimulators are designated to be held to the most rigorous clinical testing standards. But the vast majority of devices go through a less stringent review process that provides an easy path to market for devices deemed "substantially equivalent" to products already approved for use.As designed by Congress, that process should have been phased out. Instead, it became the standard path to market for thousands of devices, including hip replacements implanted in tens of thousands of patients that would later be recalled because metal shavings from the devices made some people sick.The AP found that the FDA has allowed some spinal-cord stimulators to reach the market without new clinical studies, approving them largely based on results from studies of earlier spinal stimulators.Spinal stimulators are complex devices that send electrical currents through wires placed along the spine, using a battery implanted under the skin. An external remote controls the device.The four biggest makers of spinal-cord stimulators are Boston Scientific Corp., based in Marlborough, Massachusetts; Medtronic, with headquarters in Ireland and the U.S.; Nevro, in Redwood City, California; and Illinois-based Abbott, which entered the market after its $23.6 billion purchase of St Jude Medical Inc.St. Jude's application to go to market with its first spinal stimulator contained no original patient data and was based on clinical results from other studies, while Boston Scientific's application for its Precision spinal-cord stimulator was based largely on older data, though it did include a small, original study of 26 patients who were tracked for as little as two weeks.Once approved, medical device companies can use countless supplementary requests to alter their products, even when the changes are substantial.For example, there have been only six new spinal-cord stimulator devices approved since 1984, with 835 supplemental changes to those devices given the go-ahead through the middle of this year, the AP found. Medtronic alone has been granted 394 supplemental changes to its stimulator since 1984, covering everything from altering the sterilization process to updating the design."It's kind of the story of FDA's regulation of devices, where they're just putting stuff on the market," said Diana Zuckerman, president of the National Center for Health Research, who has studied medical devices for nearly 30 years.Medical device manufacturers have cited multiple industry-funded studies showing the effectiveness of spinal-cord stimulation in the treatment of chronic pain. Experts say treatment is considered successful if pain is reduced by at least half, but not every patient experiences that much pain reduction.A 2016 study looking at different stimulation systems found "significant evidence" that they were "a safe, clinical and cost-effective treatment for many chronic pain conditions." But Zuckerman noted that the more extensive studies came after the devices were being widely used on people."These patients are guinea pigs," she said.FDA said in a statement that it approves, clears or grants marketing authorization to an average of 12 devices per business day and its decisions are "based on valid scientific evidence" that the devices are safe and effective.Dr. Walter J. Koroshetz, director at the neurological disorders and stroke division at the National Institutes of Health, said trials for medical devices like spinal-cord stimulators are generally small and industry-sponsored, with a "substantial" placebo effect."I don't know of anyone who is happy with spinal-cord technology as it stands," Koroshetz said. "I think everybody thinks it can be better." ___ Every time Jim Taft walked into his pain management doctor's office, he would glance at the brochures touting spinal-cord stimulators - the ones with pictures of people swimming, biking and fishing.Inside the exam room, Taft said, his doctor told him the device had been successful for his other patients and would improve his quality of life.On lifetime worker's compensation after his right arm was crushed as he was hauling materials for an architectural engineering company, Taft had been seeing the doctor for five years before he decided to get a stimulator in 2014. What finally swayed him, he said, was the doctor's plan to wean him off painkillers."I felt backed into a corner," said, Taft, who lives in West Columbia, South Carolina.Taft said his pain management doctor praised the technology, saying stimulators had improved the quality of life for his patients. But four years later, Taft is unable to walk more than a few steps.Taft is one of 40 patients interviewed by the AP who said they had problems with spinal-cord stimulators. The AP found them through online forums for people with medical devices. Twenty-eight of them said their spinal-cord stimulators not only failed to alleviate pain but left them worse off than before their surgeries.Zuckerman, who has worked at the U.S. Department of Health and Human Services and as a senior policy adviser to then-first lady Hillary Rodham Clinton, said no doctor wants to think they're harming patients."But there's a tremendous financial incentive to downplay, ignore or forget bad patient experiences and just focus on how happy patients are," she said.More than half the patients interviewed by the AP said they felt pressured to get stimulators because they feared their doctors would cut off their pain medications - the only thing helping them.Stimulators are considered a treatment of "last resort" by insurance companies, as well as Medicare and Medicaid. That means doctors must follow a protocol before insurance will pay for the device and implantation.Physicians must show that conservative treatments failed to help, and patients also undergo psychological assessments to evaluate the likelihood of success. They then typically undergo a trial period lasting three days to a week with thin electrodes inserted under the skin. If patients say they got relief from the external transmitter sending electrical pulses to the contacts near their spines, they have surgery to implant a permanent stimulator.Taft said his three-day trial helped reduce his pain so, a few days before his surgery, he began preparing for a new life. He ordered lumber to refurbish a patio and deck for his wife, Renee, as thanks for her years of support.In April 2014, Boston Scientific's Precision stimulator was implanted in Taft by Jason Highsmith, a Charleston, South Carolina, neurosurgeon who has received $181,000 from the company over the past five years in the form of consulting fees and payments for travel and entertainment. A Boston Scientific sales representative was in the operating room - a common practice, the AP found.Highsmith would not comment on the payments. Other doctors have defended the practice, saying they do important work that helps the companies - and ultimately patients - and deserve to be compensated for their time.From the time Taft was cut open and the device placed inside his body, he had nothing but problems, according to hundreds of pages of medical records reviewed by the AP. The device began randomly shocking him, and the battery burned his skin.Taft and his wife complained repeatedly, but said his doctors and a Boston Scientific representative told them that spinal-cord stimulators don't cause the kind of problems he had.That runs counter to Boston Scientific's own literature, which acknowledges that spinal stimulators and the procedures to implant them carry risks, such as the leads moving, overstimulation, paralysis and infections.That also is not reflected in the AP's analysis of FDA injury reports, which found shocking and burning had been reported for all major models of spinal-cord stimulators. For Boston Scientific devices, infection was the most common complaint over the past decade, mentioned in more than 4,000 injury reports.In response to questions, the company called infection "unfortunately a risk in any surgical procedure" that the company works hard to avoid. It added that the FDA's data "shouldn't be interpreted as a causal sign of a challenge with our device. In fact, many examples of reportable infections include those that were caused by the surgical procedure or post-operative care." "In our internal quality assessments, over 95 percent of the injury reports were temporary or reversible in nature," the company added.Taft said had he known the devices hurt so many people, he would have reconsidered getting one. A Boston Scientific sales representative tried reprogramming the device, he said, but nothing worked."I told them that it feels like the lead is moving up and down my spine," Taft said. "They said, 'It can't move.'" But in July 2014, X-rays revealed the lead indeed had moved - two inches on one side.Highsmith told the AP the electrode broke from "vigorous activity," though Taft said that would not have been possible due to his condition. Taft said he was in such bad shape after his surgery that he was never able to redo the patio and deck for his wife or do anything else vigorous.That October, Highsmith said, he operated on Taft to install a new lead, tested the battery and reinserted it.Still, Taft's medical records show that he continued to report numbness, tingling and pain. During a January 2015 appointment, a physician assistant wrote that the device "seemed to make his pain worse." The stimulator was surgically removed in August 2015. The following June, Taft got a second opinion from a clinic that specializes in spinal injuries, which said he had "significant axial and low back pain due to implantation and explantation" of the stimulator.Highsmith said other doctors have documented severe arthritis in Taft and that, while he has not examined Taft in more than three years, it's "likely his current condition is the result of disease progression and other factors." He did not answer questions about whether he informed Taft of the risks associated with stimulators.The doctor said the overwhelming majority of his spinal-cord stimulator patients gain significant pain relief."Unfortunately, in spite of the major medical breakthroughs with devices like these, some patients still suffer from intractable pain," he said.Renee Taft, a paralegal, reached out to Boston Scientific in 2017, but said the company refused to help because her husband's stimulator had been removed and blamed Taft for his problems, also saying he had engaged in "rigorous physical activity" after surgery.In the letter from the company's legal department, Boston Scientific also noted that federal law shielded manufacturers from personal liability claims involving medical devices approved by the FDA.In response to questions from the AP, Boston Scientific again blamed Taft's "activity level" but didn't elaborate. The company also said other factors could contribute to his problems such as "hyperalgesia, a phenomenon associated with long-term opioid use which results in patients becoming increasingly sensitive to some stimuli." Brenda Simpson-Davis of Milton, Florida, said Boston Scientific also disregarded her complaints after her husband suffered a life-threatening infection following implant surgery.George Davis, 57, had three Medtronic spinal-cord implants between 2003 and 2007 after a car accident mangled his back. They temporarily reduced some of his pain, but he said the non-rechargeable batteries that were supposed to last for years never did and he tired of multiple surgical removals.In 2015, his pain management doctor urged him to try Boston Scientific's Precision Spectra, which he called the best on the market. Unlike Davis's old models, it had a rechargeable battery.Within weeks of his surgery, Davis said, he started feeling pain shooting down his back and legs and a burning sensation at the implant site. After his skin started turning black, the doctor performed emergency surgery to remove the device.Months later, Davis reluctantly agreed when his doctor urged him to try another Boston Scientific model but found that device even worse.Over the next year, he spent more than 100 days in and out of hospitals battling a life-threatening infection. Today, Davis says he has trouble getting out of bed.Boston Scientific said it never received the stimulators that were implanted in Taft and Davis so could not "conclusively identify" the causes of their problems. "Numerous factors can contribute to a patient's ongoing symptoms, from increased physical activity to the onset of pain in other areas," the company said.Simpson-Davis said she spoke with attorneys around the country, who warned her about the high bar set for a lawsuit . Finally, she found a Texas lawyer who said he will consider taking the case if she can find another two dozen potential plaintiffs."To me, it's not about the money, It's about the people. It's about them knowing what they're getting themselves into," she said.___ For years, Valerie McJunkin had been seeking relief from a rare neurological disorder that made her legs and feet feel like they were on fire. So when a medical device company sales representative and her West Virginia pain management doctor recommended what sounded to her like a "miracle device," she was all in.They said a new kind of stimulator - one that targeted a bundle of sensory nerve cells in the lower back - was better than a spinal-cord device. She just needed to undergo a weeklong trial.When McJunkin showed up at the pain clinic this January for the trial, the Abbott sales representative was there, along with her doctor and his staff. They explained every detail. This device wasn't for everyone, but she was the perfect candidate, she recalled them saying.Over the next week, they called or texted her nearly every day to see if the stimulator was easing her torment. And since the trial did seem to help, she went ahead with the implant.Within days, though, the device began randomly shocking her - a sharp pain that felt like a lightning bolt.When McJunkin called her doctor and the Abbott representative, she said they suggested that she was at fault because "stimulators don't do that." It wasn't until she received a certified letter from Abbott in March that she learned it wasn't all in her head: The company said her device was being recalled due to a glitch that could cause patients some "discomfort." Since 2005, there have been 50 recalls involving spinal stimulators, averaging about four per year in the last five years. Roughly half the recalls involved stimulators made by Medtronic, the world's largest device manufacturer, though none warned of a risk of serious injury or death.In early September, McJunkin invited an AP reporter to accompany her when she met with her doctor and the company sales representative to request the device be removed.The Abbott salesman and her doctor both suggested she get another stimulator, saying she had run out of options, especially since her doctor couldn't write prescriptions for opioids because of a government crackdown. If she didn't get another stimulator, he said, she faced a lifetime of pain. He did not suggest other options, such as steroid shots or continued physical therapy."I'm not trying to force your mind," the doctor said. "But for me, would I want to live my life like this?... If I get that new battery and it totally helps, that changes my life 180 degrees, right? But if I don't I already know what's going to happen to me: I'll be suffering for the rest of my life." On the drive home to Martinsburg, West Virginia, McJunkin gripped the steering wheel of her car, her tattoo reading "persevere" visible on her forearm."You trust your doctor. You think he's going to do the right thing," she said. She paused, fighting back tears. "I just wanted to live without pain. But now that hope is gone." In late October, her doctor removed the device.The experience of nearly all the 40 patients interviewed by the AP mirrored McJunkin's: Their pain was reduced during the trial but returned once their stimulators were implanted.Experts say the answer may be a placebo effect created when expectations are built up during the trial that only the stimulator can offer relief from pain, exacerbated by patients not wanting to disappoint family members, who often have been serving as their caregivers."If patients know this is a last resort, a last hope, of course they will respond well," said Dr. Michael Gofeld, a Toronto-based anesthesiologist and pain management specialist who has studied and implanted spinal-cord stimulators in both the U.S. and Canada.By the time the trial ends, the patient is "flying high, the endorphin levels are high," Gofeld said.Manufacturer representatives are heavily involved during the entire process. Along with often being in the operating room during surgery in case the physician has questions, they meet with patients to program the devices in the weeks following surgery.Most of the patients interviewed by the AP said the adjustments to their devices were performed by sales representatives, often with no doctor or nurse present. That includes one patient who was billed for programming as if the doctor was in the room, though he was not."People who are selling the device should not be in charge of maintenance," Gofeld said. "It's totally unethical." In a 2015 Texas case, a former Medtronic sales representative filed suit contending she was fired after complaining that the company trained employees to program neurostimulators without physicians present. She also claimed that a Medtronic supervisor snatched surgical gloves away from her when she refused to bandage a patient during a procedure, pushed her aside and then cleaned and dressed the patient's wound. Medtronic denied the allegations, and the case was settled on undisclosed terms.In the Justice Department case involving Medtronic, a salesman who said he earned as much as $600,000 a year selling spinal-cord stimulators claimed sales representatives encouraged physicians to perform unnecessary procedures that drove up the costs for Medicare and other federal health programs."While there have been a few instances where individuals or affiliates did not comply with Medtronic's policies, we acted to remedy the situation in each case once discovered and to correct any misconduct," the company said.Gofeld said he believes stimulators do work, but that many of the problems usually arise when doctors don't choose appropriate candidates. And he thinks the stimulators are used too often in the U.S.Nevro, one of the four big manufacturers, has cited estimates that there are as many as 4,400 facilities in the U.S where spinal-stimulation devices are implanted by a variety of physicians, including neurosurgeons, psychiatrists and pain specialists.It's a lucrative business . Analysts say stimulators and the surgery to implant them costs between $32,000 and $50,000, with the device itself constituting $20,000 to $25,000 of that amount. If surgery is performed in a hospital, the patient usually stays overnight, and the hospital charges a facility fee for obtaining the device. Costs are typically covered by insurance.The AP found that doctors can make more money if they perform the surgery at physician-owned outpatient surgery centers, since the doctor buys the device, marks it up and adds on the facility fee.In Canada, where Gofeld now works, he said the surgeries are done only by those who specialize in the procedures. He said spinal-cord stimulators should be used when pain starts and not after failed back surgeries."By then," he said, "it's too late." ___ While manufacturers and top FDA officials tout stimulators as a weapon in the battle against opioids, neurosurgeons like Steven Falowski are the front-line evangelists."Chronic pain is one of the largest health-care burdens we have in the U.S. It's more than heart disease, cancer and diabetes combined," Falowski said in an interview.He referred AP to Corby, as one of his surgical patients who was helped by a spinal-cord stimulator.Corby got the device more than two years ago and says that, after some initial adjustments, he hasn't had any further problems. He says he wouldn't trade the stimulator for opioids."I was actually buying them on the street ... a little like a druggie because I couldn't get them anymore" from his pain doctor, Corby said.Falowski said opioids are good for acute pain, but were never meant to treat long-term chronic pain. For him, that's where spinal-cord stimulators come in.If they're used early enough for pain, they can prevent people from going on opium-based pain killers, said Falowski, who speaks at neuromodulation conferences and teaches other doctors how to implant stimulators.Since 2013, device manufacturers have paid Falowski - or St. Luke's University Health Network in Fountain Hill, Pennsylvania, where he works - nearly $863,000, including $611,000 from St. Jude or its new parent company, Abbott, according to the Centers for Medicare and Medicaid Services database. The payments range from consulting fees to travel and entertainment expenses.Falowski said he has conducted research and done other work for manufacturers, adding, "The contracts with industry are with my hospital and not with me." St. Luke's told the AP that it keeps the majority of the payments from device makers, but that Falowski "may receive a portion of these payments through his annual compensation." Another of Falowski's patients was Lisa Snyder of Kempton, Pennsylvania, who was searching for relief from a painful nerve disorder. By the time she came to Falowski, she had cycled through three spinal-cord stimulators, which were removed for reasons ranging from infection to rejection."Not everybody could do it, but he was confident he could," she said.After her fourth implant this March, "I complained about this battery right away. I knew it was positioned funny. It burned," Snyder said.AP's analysis showed Abbott products were more likely than other major models to include reports of a hot or burning sensation near the site of the battery, with about 5,600 injury reports since 2008 referring to the words "heat" or "burn." Abbott said that many of the "adverse events" reports in the FDA's data stemmed from a device that was voluntarily recalled in 2011. The company added that feeling a temperature increase at the implant site "is often a reality for rechargeable spinal-cord stimulation systems," which is why the company is now concentrating on devices that do not need to be recharged.Snyder said she felt like Falowski's nurse and physician assistant downplayed the problems and that the reprogramming of her device was conducted by the Abbott sales representative, with no medical staff present. On at least one occasion, she was charged as if the medical staff was there, when she said they weren't, according to insurance bills reviewed by the AP.Despite insisting nothing was wrong with the unit, Snyder said, Falowski called her one day out of the blue. "He said 'Under no circumstances are you to turn it on.' I asked him why and he wouldn't say," Snyder recalled.Falowski then scheduled immediate surgery to remove the stimulator, she said.Falowski called Snyder a difficult patient and said she was receiving "100 percent pain relief" when she had the stimulator removed, adding that she "remained very appreciative of her care." He added that programming is "performed under the direction of a physician." "The physician is not present during the entire programming session, but provides oversight and direction....The only time programming sessions are billed is when the physician is actively seeing the patient during a visit which was the case with this patient," he said.Snyder disputed the doctor's characterization of her and became angry after being told Falowski and his hospital received money from manufacturers."They need to be a little bit upfront," she said.Falowski said doctors do important work for medical device companies, and he has been involved in device development, education, clinical trials and research."You're trying to help patients and you realize as a physician by yourself you're not going to generate $200 million to make the next best implant for a patient and it's going to take a company to do that," he said. "So I think the important part in that relationship is transparency and disclosures." Experts interviewed by the AP said doctors are not legally required to tell their patients about financial relationships with medical device manufacturers, but that it would be the right thing to do."The patient should be fully informed before consenting to a procedure," said Genevieve P. Kanter, an assistant professor at the University of Pennsylvania who specializes in internal medicine, medical ethics and health policy.All Snyder ever wanted was to feel better. Today, she often is immobilized by pain.Before the latest stimulator, she could walk, stand and cook meals. Now, she finds it hard to get out of bed and rarely leaves her house. She says the device has ruined her life."My fear is I'll be like this forever," she said.___ Washington D.C.-based Associated Press reporters Meghan Hoyer and Matthew Perrone contributed to this report, as did Denver-based video journalist P. Solomon Banda.___ Contact AP's investigative team at
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