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Ethicon Media Monitoring 1/15/2018
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Can Your Hip Replacement Kill You?
Jan 12, 2018 | The New York Times
By Jeanne Lenzer
... About 32 million Americans — or about one in 10 — have at least one medical device implanted, from artificial joints to cardiac stents, surgical mesh, pacemakers, defibrillators, nerve stimulators, replacement lenses in eyes, heart valves and birth control devices. -
Johnson & Johnson Ordered to Pay NJ Resident $15 Million
Jan 12, 2018 | New Brunswick Today
By Dave Schatz
On December 14, a Johnson & Johnson (J&J) subsidiary was ordered to pay $15 million to a woman implanted with its faulty transvaginal mesh product nine years ago. -
Alison Blake took her own life one year after regulators were implored to find mesh-injured women
Jan 15, 2018 | Newcastle Herald
By Joanne McCarthy
STATE and federal health bodies were urged to audit a NSW private hospital, and find injured women, one year before primary school teacher Alison Blake took her own life after devastating complications following pelvic mesh surgery at the hospital. -
Your Turn: Dental Issues and Mesh Complications
Jan 14, 2018 | Mesh Medical Device Newsdesk
So many people who have had polypropylene mesh implanted complain of dental issues – missing teeth, cracked teeth, gums receding.
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Can Your Hip Replacement Kill You?
Jan 12, 2018 | The New York Times
By Jeanne Lenzer
When Stephen Tower’s right hip gave out in 2006, he asked his surgeon to implant an artificial one — specifically, a metal-on-metal hip called the ASR XL, made by Johnson & Johnson. He knew what he was talking about: As an orthopedic surgeon, Dr. Tower specializes in complex hip replacements. But what he knew wasn’t enough to protect him from a defect in the device.
Five years after his surgery, and in excruciating pain, Dr. Tower underwent more surgery, this time to have the device replaced. When the surgeon sliced into his hip, what he saw looked like a crankcase full of dirty oil. Tissue surrounding the hip was black. Cobalt leaking from the ASR hip had caused a condition called metallosis, destroying not only local muscle, tendons and ligaments, but harming Dr. Tower’s heart and brain as well.
Despite Dr. Tower’s repeated efforts to warn his colleagues and the company that the implants were harming patients, Johnson & Johnson continued to market metal-on-metal hips. While it withdrew the ASR XL model from the market in 2010, citing slow sales, it continued to sell another, similarly problematic model, the Pinnacle, until 2013.
More than 9,000 patients filed suit against the company, and on Nov. 16, six New York patients won a $247 million trial verdict for serious harms caused by the Pinnacle hip implants and for failing to warn doctors and patients about its dangers. These suits and others are pulling back the curtain on what some doctors call the Wild West of medicine: the untested and largely unregulated medical device industry.
About 32 million Americans — or about one in 10 — have at least one medical device implanted, from artificial joints to cardiac stents, surgical mesh, pacemakers, defibrillators, nerve stimulators, replacement lenses in eyes, heart valves and birth control devices.Continue reading the main storyRECENT COMMENTSZora Margolis 10 hours ago
I would encourage anyone anxious about a needed hip replacement to read _Vanishing Bone_ by William H. Harris, M.D. recently published by...Been There 10 hours ago
"Medical interventions are now the third-leading cause of death in the United States, and devices play an increasing role in that statistic...Reggie 10 hours ago
I have a friend who was having hip replacement surgery and something went wrong that affected his brain. From that point forward he was lost...SEE ALL COMMENTS
These devices have helped countless people, and some have saved lives. But many others are harmed — and doctors and patients are at the mercy of manufacturers’ claims about the safety and efficacy of the devices. Medical interventions are now the third-leading cause of death in the United States, and devices play an increasing role in that statistic.
Many people assume that the Food and Drug Administration requires rigorous testing of medical devices before they are approved, the same as the lengthy approval process it requires for new drugs. In fact, most high-risk devices on the market, including implants, have undergone no clinical testing at all.
Although the standard for approval of a new drug usually calls for two randomized, controlled clinical trials, the standard for many medical devices is no standard at all. Since medical devices didn’t come under regulatory control by the F.D.A. until 1976, the agency simply grandfathered in all devices that were already on the market under a provision known as 510(k), which allows manufacturers to sell most new devices without requiring any clinical testing as long as the manufacturer says its product is “substantially equivalent” to an existing device.
In addition to the 510(k) pathway, medical device companies can avoid clinical testing for the highest risk devices through the supplement pathway by telling the F.D.A. they made a minor change to a previously approved device. The use of these loopholes is widespread: A study published in The Journal of the American Medical Association in 2009 found that only 5 percent of high-risk implanted cardiac devices even partly met the standard for drug testing.
Metal hips are far from the only devices with catastrophic consequences. In October 2007, Medtronic, a leading medical device manufacturer, recalled the lead wires in its Sprint Fidelis defibrillator after they were found to fracture and misfire, harming or even killing patients. The devices had not been clinically tested and were approved for sale by the F.D.A. through the supplement pathway. But in this case, the “minor change” was a fatal one; the new wire was thinner and prone to fracture.
By the time of the recall, 268,000 leads had been implanted in patients worldwide, the majority in the United States. After the recall, many patients rushed to have the devices removed, but removal posed its own dangers, causing major complications in 15 percent of patients.
Even when devices are subjected to trials, the F.D.A. sometimes ignores danger signs detected by those studies. In 1997, during the approval process of the vagus nerve stimulator, a device made by Cyberonics to treat epilepsy, an F.D.A. adviser voiced concerns about a high death rate noted in patients with the device. But the agency didn’t stop the device from going to market. Instead, it awarded conditional approval, meaning that Cyberonics would have to conduct safety studies after the device was on the market.
The agency didn’t even require Cyberonics to inform patients that there was concern about the death rate, or that they were effectively being made unwitting guinea pigs. When Cyberonics finally submitted five studies that it said proved the device was safe, it failed to include death data for any of the studies, a move the F.D.A. defended, saying the agency hadn’t asked the company to count deaths, only to “characterize” deaths.
How it’s possible to characterize deaths without including any actual data on deaths is anyone’s guess.
With such shockingly lax regulations, it’s no surprise that device recalls have risen over the years; in 2003, there were eight Class 1 device recalls, which the F.D.A. defines as indicating “a reasonable probability” that a device will “cause serious adverse health consequences or death.” In 2016, that number rose to 117, affecting hundreds of thousands of patients.
Loose oversight of devices poses a threat to public health. Yet the Trump administration’s picks to lead the Department of Health and Human Services and the F.D.A. are advocates of deregulation, which they insist will speed the march of “lifesaving” devices to market. This presumes that such speed and innovation is actually lifesaving or life-enhancing. The number of device-related deaths shows how dangerous that presumption is.
The fact that the F.D.A. has allowed lax practices like the 510(k) loophole to continue, despite calls for reform by institutions like the National Academy of Medicine, poses the question of why the F.D.A. would put profits ahead of safety. One clue rests in history: In 1988, President Ronald Reagan changed the position of F.D.A. commissioner from civil servant to political appointee, which has meant that presidents, with their war chests fattened by the drug and device industries, have repeatedly appointed industry-friendly commissioners, with rare exception.
Returning to a system in which F.D.A. commissioners are civil servants is perhaps a first step, but it needs to be the first of many. As a government agency, the F.D.A. is supposed to serve as a bulwark between corporate profiteering and the public welfare. Its continued allowance of regulation loopholes like 510(k), despite the significant demonstrated cost to public welfare, calls into serious question the agency’s fulfillment of its stated mission to protect public health by ensuring safety, efficacy and security.
https://www.nytimes.com/2018/01/13/opinion/sunday/can-your-hip-replacement-kill-you.html?_r=0
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Johnson & Johnson Ordered to Pay NJ Resident $15 Million
Jan 12, 2018 | New Brunswick Today
By Dave Schatz
Ethicon Subsidiary Loses Second Vaginal Mesh Case in New Jersey Superior Court
NEW BRUNSWICK, NJ–On December 14, a Johnson & Johnson (J&J) subsidiary was ordered to pay $15 million to a woman implanted with its faulty transvaginal mesh product nine years ago.
Elizabeth Hrymoc, age 71, had sued Somerville-based Ethicon, whose parent company, J&J, has been located in the Hub City since 1886.
The award approved by the jury included $4 million in compensatory damages for the plaintiff, and $1 million for her husband, as well as $10 million in punitive damages.
“Unfortunately, her injuries are permanent,” Hrymoc’s attorney Adam Slater told Philly.com regarding the New Jersey resident’s predicament.
“One of the fundamental and horrific defects with this device is the inability to successfully treat complications, and Elizabeth is a clear illustration of what happened to countless other women.”
The jury reportedly ruled that Ethicon should have provided sufficient warning about the possibility of injury connected to the product and its thermoplastic polymer mesh.
The case marked the second pelvic mesh trial in New Jersey, just one of some 9,000 cases around the nation centering on J&J’s medical devices.
A few months earlier, "a Philadelphia jury awarded $57 million to a Pennsylvania woman who required three operations to remove the implants which left her chronically incontinent,” reported Philly.com.
Hrymoc's case was heard in Bergen County Superior Court, but J&J says they are appealing the verdict to a higer court.
“Ethicon intends to appeal this verdict, as we believe that the evidence showed that the company appropriately informed surgeons of pertinent complications and that the products were properly designed and studied,” said company spokeswoman Mindy Tinsley in a statement.
The first New Jersey case had resulted in an $11 million award that was upheld by the Appellate Division. The company appealed to the New Jersey Supreme Court, but they declined to hear the case.
Hrymoc “had two mesh implants made by the Ethicon division of J&J – Prolift, a large multi-armed mesh implant used to hold up sagging internal organs, and a TVT-O, used to support a urethra to treat stress urinary incontinence,” according to MeshNewsDesk, an online outlet which seeks to "investigate issues behind the headlines concerning medical devices and surgical mesh."
Only one of the two Ethicon products is still sold, with Prolift being quietly taken off the market in 2012, according to the report.
The jury determined that Prolift had been defectively designed and that the company failed to warn of its risks, and that it failed to warn of the risks of TVT-O, according to MeshNewsDesk's Jane Akre.
"Ms. Hrymoc underwent three revision/removal surgeries but the last one had to be stopped midway through because she lost too much blood and needed transfusions,” reported Akre. “Now she lives with chronic pain, mesh erosion and dyspareunia. The arms of the Prolift were banded, evidence showed.”
“I want to talk about the women who have shown courage and resolve – this verdict is for them!” Slater told MeshNewsDesk. "Elizabeth Hrymoc always made it clear she was going to trial for the other women still in the court system, waiting for their trials and settlements and for the opportunity to go to trial."
“This outcomes gives hope their time will come.”
http://newbrunswicktoday.com/article/johnson-johnson-ordered-pay-nj-resident-15-million
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Alison Blake took her own life one year after regulators were implored to find mesh-injured women
Jan 15, 2018 | Newcastle Herald
By Joanne McCarthy
STATE and federal health bodies were urged to audit a NSW private hospital, and find injured women, one year before primary school teacher Alison Blake took her own life after devastating complications following pelvic mesh surgery at the hospital.
Between June and September 2014 a pelvic mesh patient advocate urged NSW Health, the NSW Medical Council, the NSW Health Care Complaints Commission and the federal medical device regulator, the Therapeutic Goods Administration, to urgently investigate the hospital where a doctor with an “extensive” complaint history was implanting a device that was cancelled by the end of 2014 because of lack of evidence it was safe to use.
The state and federal bodies were told possibly 100 or more women were implanted with modified versions of the device; injuries to patients were not being reported to authorities; women were undergoing multiple surgeries after complications and “the full extent of patient injury and device failure will not be known without proper investigation”.
“A full clinical audit of (pelvic mesh) surgeries at the hospital needs to be conducted by the Department of Health, as there are likely many more patients out there,” a complaint to the regulators in 2014 said.
Mrs Blake died in June, 2015 only two weeks after a specialist confirmed she would have to self-catheterise for the rest of her life and there was little that could be done to address her severe, permanent and disabling pain.
Mrs Blake’s daughter, Leesa Tolhurst, wept on Thursday after learning authorities were made aware of the need to find injured women like her mother, one year before Mrs Blake took her own life after she was implanted with the problem mesh device at the hospital in October, 2013, by the doctor with the “extensive” complaint history. The device was cancelled in November, 2014.
Do they even recognise they have a duty of care to the women? If you’re cancelling a device that’s already been put in people you should find out what’s happened to them.Leesa Tolhurst
In a final letter to her daughter Mrs Blake, 64, said she could not bear the thought of leaving Ms Tolhurst but “the emotional torment and physical pain I’m going through are just too much”.
“I simply cannot bear to be lying on a couch for months on end and to have to rely on catheters, enemas, Temazepam, pain killers and be a burden to my family and friends,” she wrote.
Ms Tolhurst said her mother went from doctor to doctor in the final 16 months of her life, unsuccessfully seeking help for her mesh injuries. She was unaware of the more than 100,000 women worldwide who were taking legal action after mesh surgery, including many in Australia.
“I’m sitting down because I’m in shock,” Ms Tolhurst said.
“People in positions where they could and should have done something to find and help women like my mother just didn’t. They didn’t respond to that appeal for a full audit to find out how many women were left with terrible injuries. I just think that’s the cruellest thing of all.
“Do they even recognise they have a duty of care to the women? If you’re cancelling a device that’s already been put in people you should find out what’s happened to them.
“She would have wanted so much to hear from someone in authority to acknowledge that what happened to her was wrong.
“They shouldn’t just have cancelled the device and then nothing else. It’s just like trying to sweep it under the rug really quickly and not draw attention to the damage that’s been done.”
A NSW Health spokesperson said the department “deeply regrets” the pain and suffering Mrs Blake experienced from pelvic mesh complications.
A NSW Health taskforce established in July 2017, and chaired by NSW chief health officer, Dr Kerry Chant, is “coordinating a state-wide response to issues arising from the use of transvaginal (surgery through the vagina rather than the abdomen) mesh for pelvic organ prolapse”, the spokesperson said.
The statement did not refer to a state response to issues for women who received the “gold standard” incontinence mesh slings, who have also experienced severe and disabling complications.
A Therapeutic Goods Administration spokesperson said the regulator “does not have the powers to undertake audits of clinician or health facilities” and the Australian Health Practitioners Regulatory Agency was responsible for investigating complaints about health practitioners and health service providers.
http://www.theherald.com.au/story/5164880/the-cruellest-thing-of-all-daughters-shock-over-missed-pelvic-mesh-audit-calls/
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Your Turn: Dental Issues and Mesh Complications
Jan 14, 2018 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, January 14, 2018 ~ So many people who have had polypropylene mesh implanted complain of dental issues – missing teeth, cracked teeth, gums receding.
While dental issues do arise as we age, there seems to be an unusual number of dental health issues noted among the mesh-injured community. Are these mesh complications?
Here are the comments of one woman, who chooses to remain anonymous. She has a question you might help with at the end.
She is also a nurse.
“Okay my mesh brothers and sisters, I need and would so appreciate some feedback that I can show my dentist in regard to our complaints and hopefully some research which shows the adverse effects of mesh on our teeth!
“I have already spent so much over the last 5 years (5 crowns) and have lost several teeth…I am so heartbroken and I am so tired of investing thousands (that I don’t have and probably won’t ever have as I most likely won’t ever live long enough to see justice with my lawsuit!).
“I don’t have dental insurance but did purchase my dentist’s yearly plan ($250) but because my teeth are cracking so badly, because my mesh created foot-drop caused me to fall and lose a tooth 2 years ago, and because now my gums are receding, I have been told I need $15,000 more to crown the rest as they are so brittle or are losing their enamel and setting me up for high risk of decay. (Vit.D/calcium levels are within normal limits).
“I told my dentist about how many of us are suffering with biofilm/bacterial issues due to the mesh and I just know my issues started after implant in 2010 and I said this deeply concerns me because I can’t be investing in something over and over again if I am eventually gonna lose my teeth because of the mesh. (I have already had to go on disability and while I really like my dentist, I honestly feel like I am being taken advantage of).
“My dentist then looked at me and kindly said, “Well, (name) show me some concrete information on that because and I will review everything because I have never heard of anything like that.”
“I am hoping if I can provide info. to her that she will be more apt to empathetically help me and with my PTSD, I don’t want to leave her office and start over somewhere else because I am comfortable there.
“So family, if anyone could send me some links or tell what they know or have been through, I would be so grateful as I have to go back on Tuesday. Thank you!”
https://www.meshmedicaldevicenewsdesk.com/turn-dental-issues-mesh-complications/
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