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Woman disabled in a wheelchair from an operation gone wrong is told her pain will fix with counselling
Apr 4, 2016 | Ely Standard
By Kath Sansom
In a letter from her local NHS Trust she was told that cognitive behaviour therapy (CBT) should help her get back to work and a normal life. -
Breast and mesh implants cost NHS £36m in compensation
Apr 3, 2016 | Sunday Express
By Paula Murray
THE number of clinical negligence cases being heard at the Court of Session has shot up by an astonishing 224 per cent. -
Canadian women reach transvaginal mesh settlement
Apr 3, 2016 | CTVNews
Several Canadian women who say they suffered complications from transvaginal mesh used to treat incontinence and organ prolapse have reached a settlement with one of the mesh manufacturers. -
Will More Morcellator Makers Settle?
Apr 1, 2016 | Medical Device and Diagnostic Industry
By Nancy Crotti
Johnson & Johnson isn’t saying why it has been settling consumer lawsuits over power morcellators, but other manufacturers of the surgical devices linked to the spread of uterine cancer have surely taken notice. -
FDA to probe Boston Scientific implant allegations
Apr 4, 2016 | Boston Globe
By Robert Weisman
Federal regulators said Friday that they are examining allegations Boston Scientific Corp. used counterfeit raw material in vaginal mesh implants that treat urinary incontinence and other pelvic organ problems in women. -
FDA updates on Boston Scientific surgical mesh implant “counterfeit” material
Apr 1, 2016 | Mass Device
By Fink Densford
The FDA today released an update on allegations that Boston Scientific‘s (NYSE:BSX) urogynecologic surgical mesh may contain counterfeit raw material. -
Plaintiff’s lawyers ask FDA to ban Boston Scientific’s pelvic mesh
Apr 4, 2016 |
By Brad Perriello
The law firm that’s bringing a racketeering lawsuit against Boston Scientific (NYSE:BSX) accusing it of smuggling counterfeit resin asked the FDA to ban the medical device maker’s pelvic mesh products made with the allegedly impure resin. -
Citizen Petition Wants Recall of Bos Sci Surgical Mesh
Apr 1, 2016 | Medical Device and Diagnostic Industry
By Marie Thibault
A citizen petition sent to FDA this week asks the agency to issue a Class I recall of Boston Scientific's surgical mesh, alleging that it is made using Chinese counterfeit resin containing high levels of selenium. The petition quotes emails from company employees to support its claims and blasts FDA for what it calls "inaction." -
*Latest* FDA Acknowledges Potential for Counterfeit Raw Material from China in Boston Scientific Mesh
Apr 1, 2016 | Mesh Medical Device News Desk
The U.S. Food and Drug Administration (FDA) acknowledged today it is aware that some of Boston Scientific’s (BSC) urogynecologic surgical mesh may be made from counterfeit raw material.
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Apr 4, 2016 | Ely Standard
By Kath Sansom
In a letter from her local NHS Trust she was told that cognitive behaviour therapy (CBT) should help her get back to work and a normal life.
It then belittled her life-altering pain by saying she had a history of complaining to her GP because she had in the past suffered from depression.
The woman had a plastic mesh bladder sling to treat incontinence suffered after childbirth and was told it was a low risk simple operation - but it left her among thousands of women around the world suffering painful complications.
She said: “I have been left unable to walk far or sit for too long, in constant agonising pain, my life ruined, on medication to cope,” she said.
“They think if I talk for a bit with a counsellor I will be OK.
“To have your life changed beyond recognition because of surgery risks I was never properly warned about is one thing but to then be told it is all in your head is disgraceful.”
She is suing her local NHS Trust for damages because she can no longer walk far and has had to give up work.
The woman is one of many who have joined Facebook campaign Sling The Mesh and met others who have been told the mesh operation has nothing to do with her pain.
One woman said: “My surgeon said I had a disc problem making it painful to walk - yet I’ve never suffered disc problems in my life.”
Another aid: “My surgeon said I was the first person he had seen suffering mesh problems but after joining Sling The Mesh I found a woman who was in the same hospital on the same day as me having a mesh device put in, who has also suffered.
“We were both told we were the only women he had come across and it had nothing to do with mesh.”
Olive McIlroy, of campaign group Scottish Mesh Survivors, said: “There is no off switch for individuals experiencing severe complications from mesh procedures, patients are the fall-out from defectively designed, non-tested, vociferously marketed, poorly regulated and monitored polypropylene mesh medical implants.
“The life individuals experiencing mesh complications had is gone, they have a different life now, one of disability and severely restricted quality of daily living.
“We don’t ask for much just please believe we are in constant pain with a multitude of other severe symptoms and those with the power to do so introduce an immediate precautionary principle and stop all mesh medical implants now.”
Fellow mesh campaigner Elaine Holmes said: “Three out of four mesh procedures currently in use throughout the UK will no longer be used routinely in Scottish hospitals, only in exceptional circumstances due to serious safety concerns.
“One of the recommendations of the Scottish review is to encourage ‘empathy’ with patients, particularly those who developed adverse events from these procedures.
“Surgeons and NHS Trusts should read this report and listen, really listen to their patients.”
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Breast and mesh implants cost NHS £36m in compensation
Apr 3, 2016 | Sunday Express
By Paula Murray
THE number of clinical negligence cases being heard at the Court of Session has shot up by an astonishing 224 per cent.
Scotland's highest court saw action raised on serious medical failures some 545 times in 2014/15 compared to 168 the year before.
Those cases also peaked across the country's other courts with 629 separate actions in the last financial year compared to just 262 in 2013/14 indicating a 140 per cent rise.
It is thought clinical negligence claims at the civil courts cost the NHS in Scotland £36million a year in compensation. The increase is linked to scandals over breast and mesh implants.
It is thought close to 2,000 women a year undergo surgery to have medical devices fitted to treat pelvic organ prolapse and incontinence after childbirth.
However, hundreds have reported agonising complications with the mesh implants.
In October last year, Health Secretary Shona Robison apologised for the fact that it had taken a public petition to "shine light on the issue". The scandal followed a furore over breast implants when it was revealed that the silicon used in some cut-price implants was of non-medical grade.
Thousands of women north of the Border were told they could have them taken out on the NHS.
Last night the Scottish Tories health spokesman Jackson Carlaw added: "This is the evidence that the consequences of mesh implants and other controversial procedures are all too real to those affected.
"All the more inexplicable then that the sense of urgency needed to stop further damage being done continues to be frustrated." -
Canadian women reach transvaginal mesh settlement
Apr 3, 2016 | CTVNews
Several Canadian women who say they suffered complications from transvaginal mesh used to treat incontinence and organ prolapse have reached a settlement with one of the mesh manufacturers.
Bard Canada, the makers of Avaulta, Align, and Adjust brands of transvaginal mesh, has agreed to pay some $2.4 million to settle claims against three products: Avaulta, Align, and Adjust.
Bard has agreed to the settlement “without admission of liability or wrongdoing,” the agreement notice reads.
While there have been individual pelvic mesh lawsuit settlements, if approved, this would be the first class action settlement in Canada.
An approval hearing is scheduled for May 2 in which the court will determine whether the settlement agreement is fair, reasonable and in the best interests of all the women listed as class members.
Transvaginal mesh has become a popular treatment to use as support when pelvic organs such as the bladder descend in the abdomen. Many doctors prefer the surgical mesh because it lifts internal organs without full surgery, since the mesh can be implanted through the vagina.
While the mesh has been successful for some women, thousands of others in the U.S., Canada and parts of Europe have reported complications. They include infection from mesh parts breaking off inside the patient, leading to excruciating pain, painful sex, and other internal damage.
Dozens of lawsuits are underway in the U.S. and Canada. This is the first class action to be settled in Canada.
“This is a significant settlement to be able to bring compensation to women,” said Matthew Baer of McKenzie Lake Lawyers in an email to CTV News.
“Bard should be commended for working out something fair and reasonable in those circumstances.”
Donna O’Brien of Cambridge, Ont. received Bard Align transvaginal mesh in December, 2010, to treat incontinence. In a matter of weeks, she says started suffering pain and infections.
“I was going to the hospital every week” O’Brien told CTV News.
She says the mesh had started to erode and migrate through her vagina. Doctors attempted to remove the mesh but were unsuccessful. The continuing infections she says caused fluid to build around her heart, triggering a heart attack in 2011.
O’Brien says she welcomes the settlement and hopes to use the money to find a doctor who will try again to remove the remaining mesh.
“Hopefully, it will help me to find someone to get fixed – even outside of Canada,” she said.
Some 18 mesh lawsuits have been settled in the U.S., some with multi-million dollar awards.
“Hopefully, (the Bard settlement) will serve as a catalyst towards all women who have suffered similarly receiving compensation, regardless of manufacturer,” said Baer.
The settlement provides for $400,000 to the women who used Avaulta; $1.5 million to those who used Ajust and Allign, a special circumstances fund of $300,000, and $225,000 for notice and claims administration.
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Will More Morcellator Makers Settle?
Apr 1, 2016 | Medical Device and Diagnostic Industry
By Nancy Crotti
Johnson & Johnson isn’t saying why it has been settling consumer lawsuits over power morcellators, but other manufacturers of the surgical devices linked to the spread of uterine cancer have surely taken notice.
The Wall Street Journal has reported that J&J, which manufactured about 75% of the morcellators on the market, has settled approximately 70 cases and is working on reaching settlements in more. This development came just a few months after the Judicial Panel on Multidistrict Litigation consolidated several morcellator cases against J&J’s Ethicon unit in U.S. District Court for the District of Kansas.
Ethicon and other companies manufactured morcellators used by surgeons to grind up uterine tissue during hysterectomies and myomectomies for laparoscopic removal. FDA estimates of undetected cancer among these patients have fallen from 1 in 10000 to 1 in 350, although some dispute the latter figure.
Power morcellators had been used to remove patients’ uteruses and fibroid tumors in laparoscopic procedures for about 20 years before consumer outcry prompted government investigations. Some surgeons continue to use morcellators because they believe the risks of morcellation outweigh the potential adverse events of alternative procedures, like open hysterectomy.
Some health insurers, including Highmark and United Healthcare, have said they will not cover use of morcellators during hysterectomies. A number of health systems and hospitals have stopped performing hysterectomies with morcellation.
Some patients and families are probably happy to settle their lawsuits and put the matter in the past, but not the husband and wife physicians who have been among the most outspoken about the devices. Dr. Amy Reed found out soon after having a hysterectomy with a device made by German manufacturer Karl Storz GmbH & Co. that she had uterine sarcoma.
Reed’s husband, Dr. Hooman Noorchashm, said he hopes their lawsuit and others will continue so the public can see “who the players are, how they behaved, what laws were violated or need to be in place.”
Reed, a mother of six, has had several recurrences of cancer, and the family has moved to Pennsylvania from Massachusetts to be closer to her relatives, Noorchashm said.
"Every one of these complaints is really an opportunity for a public record to be created, and for the public to really understand, and for government regulators to understand, what went wrong here,” he added.
Storz has moved to dismiss the couple’s lawsuit, according to court papers. The company did not respond to a request for comment to this story.
A couple of attorneys familiar with lawsuits over medical devices said they believe that J&J’s decision to begin settling these suits will likely spur other manufacturers to consider their options.
Amy Alderfer of law firm Cozen O’Connor’s Los Angeles office has worked on cases involving vaginal mesh, insulin pumps, spinal stimulators, and implantable cardiac devices. Having one defendant settle does not necessarily create a domino effect, in her experience.
“It really probably comes down to a business decision and just looking at your own portfolio and the documents you have,” Alderfer said. “When you have someone who has a major component of the industry settling, that is something that they’ll have to take notice and think about and decide if for them if it makes wise sense from a business point of view as well.”
The combination of a major manufacturer’s decision to settle and FDA actions surrounding a device “suggests that there are times when settlement is the better option than to fight to the death,” added Melissa Markey of Hall Render Killian Heath & Lyman’s Troy, MI, office.
“Johnson & Johnson has obviously made that cost-benefit calculus and have decided that from their perspective, it is a more appropriate course of action to settle rather than to try and litigate this, which may very well be a very reasonable course of action of them to choose,” Markey said. “It seems to me that given what is becoming known about those devices that it may be a very reasonable thing to do for the device makers to settle rather than to litigate this.”
FDA issued a safety communication about power morcellators in April 2014. J&J suspended sales that month and withdrew the devices from the market in July 2014. Last year, the FBI reportedly began investigating what J&J knew about its risks before the recall. The Government Accountability Office said in September that it planned to investigate how the surgical devices were sold for so long before widespread safety concerns were raised. A dozen members of Congress petitioned GAO to look into the regulatory clearance, marketing, training, and adverse event reporting associated with morcellator use. Petitioners also asked the watchdog to determine what FDA is doing to ensure the devices, which are still commercially available from some companies, are safe.
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FDA to probe Boston Scientific implant allegations
Apr 4, 2016 | Boston Globe
By Robert Weisman
Federal regulators said Friday that they are examining allegations Boston Scientific Corp. used counterfeit raw material in vaginal mesh implants that treat urinary incontinence and other pelvic organ problems in women.
The Food and Drug Administration disclosed the probe as it issued a safety alert about the products. The agency didn’t recommend women remove the implants.
“Available data do not suggest any decreased benefit associated with the device,” the FDA said. However, the alert said, “the FDA believes that health care professionals and their patients should be aware of this investigation.”
FDA officials also said Boston Scientific will conduct new tests on the safety and effectiveness of the product — technically called urogynecologic surgical mesh — over the next few months, and the agency will review the results.
In a statement, Marlborough-based Boston Scientific said it “does not use ‘counterfeit’ or ‘adulterated’ materials” in its medical devices.
“We have the highest confidence in the safety of our mesh devices,” the statement said. “We have shared our test data with the FDA, and are fully cooperating with the agency’s requests for information as part of our ongoing discussions.”
Boston Scientific and other companies that market vaginal mesh implants have been the targets of thousands of lawsuits over the past decades by women who have used the products to fix a common gynecologic condition called pelvic organ prolapse. Many have reported painful sexual intercourse, infections, urinary problems, overall discomfort, and bleeding.
In its safety alert, the FDA said it “is not currently aware that the alleged counterfeit raw material contributes to adverse events associated with these products.”
Mostyn Law, a Houston law firm, in January filed a suit in US court in West Virginia accusing Boston Scientific of selling defective vaginal mesh implants made from materials smuggled from China, and putting the health of thousands of women at risk. The suit, which seeks class-action status, asks for unspecified damages for as many as 55,000 women a year who received the mesh product since 2012.
Boston Scientific denied the charges and said it would vigorously fight the suit. The company, which already faces about 30,000 lawsuits for its vaginal mesh products, paid $119 million last year to settle about 3,000 of these cases.
Mostyn Law petitioned the FDA on Thursday seeking a recall of Boston Scientific’s mesh products. But an FDA spokeswoman said Friday that the agency had not received the petition and declined to comment on it.
Amber Mostyn, an attorney at Mostyn Law, faulted the FDA for not recalling the product, saying “it is absurd to rely on testing by the company.”
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FDA updates on Boston Scientific surgical mesh implant “counterfeit” material
Apr 1, 2016 | Mass Device
By Fink Densford
The FDA today released an update on allegations that Boston Scientific‘s (NYSE:BSX) urogynecologic surgical mesh may contain counterfeit raw material.
The agency said it was “examining these allegations” to determine the next steps, but said it is currently not away that the alleged counterfeit raw material is contributing to adverse events with the products.
“It is not uncommon for a firm, based on its own appropriate evaluation of potential suppliers and raw material, to change the source of a raw material after the device has been cleared by the FDA, and such a change often does not require FDA premarket review. However, in light of the allegations, Boston Scientific will conduct additional testing relevant to the safety and effectiveness of the finished product,” the FDA wrote in its update.
The FDA said the additional testing would be sufficient to determine whether or not the mesh made from alleged counterfeit raw material are equivalent to meshes manufactured with material from the original supplier. The agency said it expects the testing will take several months to complete.
Health care professionals and their patients should be “aware of the investigation,” the FDA said, and plan for the FDA to review to make the “most informed health care decisions.”
The FDA advised against removal of the surgical mesh in women who already have it implanted as “available data do not suggest any decreased benefit associated with the device.”
The federal watchdog said it will update with any new information.
In January, a class-action racketeering lawsuit was filed against Boston Scientific accusing it of illegally smuggling counterfeit resin made in China to make pelvic mesh, after its original supplier allegedly refused to continue providing the product because it’s not supposed to be implanted in humans.
The lawsuit was filed Jan. 12 in the U.S. District Court for Southern West Virginia, the venue for multi-district litigation against a clutch of companies over their respective mesh products for treating female urinary incontinence and pelvic organ prolapse.
Plaintiff Teresa Stevens alleged that Marlborough, Mass.-based Boston Scientific conspired with subsidiaries in Belgium and Ireland to use the counterfeit resin to make the Advantage mesh used in all of its pelvic mesh products.
Boston Scientific told CNNMoney that “patient safety is of the utmost importance, and we dedicate significant resources to deliver safe, high-quality products. We don’t believe the case has merit and intend to vigorously defend these claims.”
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Plaintiff’s lawyers ask FDA to ban Boston Scientific’s pelvic mesh
Apr 4, 2016 |
By Brad Perriello
The law firm that’s bringing a racketeering lawsuit against Boston Scientific (NYSE:BSX) accusing it of smuggling counterfeit resin asked the FDA to ban the medical device maker’s pelvic mesh products made with the allegedly impure resin.
Teresa Stevens sued Boston Scientific in January, alleging that the Marlborough, Mass.-based company conspired with subsidiaries in Belgium and Ireland to use counterfeit resin imported from China to make the Advantage mesh used in its pelvic mesh products.
A federal judge ruled that the FDA has jurisdiction over the case, as “many of the factual allegations contained in the complaint and supporting documents are based on alleged violations of statutes and regulations over which the FDA exercises its expertise and impressive administrative dominance.”
Now the law firm representing Stevens, Houston-based Mostyn Law, is petitioning the FDA to ban Boston Scientific’s mesh products made with the purportedly counterfeit resin.
Boston Scientific commented, saying it “Does not use “counterfeit” or “adulterated” materials in our medical devices.”
“The company rejects the allegations in the petition to the Food and Drug Administration filed by a Texas-based law firm on March 31, 2016. Boston Scientific has a robust quality system and dedication to patient safety. We stand behind our products, the materials used in those products and our commitment to women’s health,” the company wrote in a press release.
The company said that in 2011, it shifted its supplier of Marlex resin, and in doing so put the resin through a “rigorous battery of tests to demonstrate equivalency,” as well as conducting extensive mechanical tests to ensure the products made with the new material meets product specifications.
“We have the highest confidence in the safety of our mesh devices. We have shared our test data with the Food and Drug Administration, and are fully cooperating with the agency’s requests for information as part of our ongoing discussions. Additionally, we have offered to conduct further biocompatibility and chemical characterization testing to complement the results from existing tests. This entire process is expected to take several months, depending on the individual tests,” Boston Scientific wrote.
The FDA today released an update on allegations that Boston Scientific’s urogynecologic surgical mesh may contain counterfeit raw material.
The agency said it was “examining these allegations” to determine the next steps, but said it is currently not away that the alleged counterfeit raw material is contributing to adverse events with the products.
The FDA said the additional testing would be sufficient to determine whether or not the mesh made from alleged counterfeit raw material are equivalent to meshes manufactured with material from the original supplier. The agency said it expects the testing will take several months to complete.
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Citizen Petition Wants Recall of Bos Sci Surgical Mesh
Apr 1, 2016 | Medical Device and Diagnostic Industry
By Marie Thibault
A citizen petition sent to FDA this week asks the agency to issue a Class I recall of Boston Scientific's surgical mesh, alleging that it is made using Chinese counterfeit resin containing high levels of selenium. The petition quotes emails from company employees to support its claims and blasts FDA for what it calls "inaction."
Mostyn Law filed the petition on behalf of a lead patient plaintiff in a federal class action lawsuit against Boston Scientific. The petition asks FDA to announce an immediate Class I recall of Boston Scientific products it claims were made with the counterfeit material from China. The petitioners also want the agency to send warnings to customers, users, and patients of products allegedly made made with counterfeit resin, and to treat this situation like a 2010 Class I recall of counterfeit C.R. Bard surgical mesh.
The petitioners claim that after the U.S. supplier of Marlex, a type of propylene used to make Boston Scientific surgical mesh, declared in 2004 that the material was not fit for permanent use in the human body and stopped selling it for medical applications, Boston Scientific allegedly was able to source the material from a distributor before starting to run out in 2011. The petition authors claim that Boston Scientific "turned to a known Chinese counterfeiter to satisfy its Marlex needs" and include excerpts allegedly from company employees discussing the situation. In addition, the petition alleges that the company "smuggled" the counterfeit material out of China. This is a "change of material," the petition claims, and should require a new 510(k) application.
Boston Scientific denied the petition's claims in an April 1 public statement. That statement read, in part:
"Boston Scientific does not use 'counterfeit' or 'adulterated' materials in our medical devices. The company rejects the allegations in the petition to the Food and Drug Administration filed by a Texas-based law firm on March 31, 2016. Boston Scientific has a robust quality system and dedication to patient safety. We stand behind our products, the materials used in those products and our commitment to women's health. Boston Scientific mesh products provide relief to thousands of patients for painful and progressive medical conditions. These mesh devices are made with Marlex HGX-030-01, a polypropylene resin. Polypropylene resins like Marlex have been part of implantable medical devices for more than 50 years."
"The FDA needs to do its job and ban this outright. We've clearly documented the health risks," said attorney Amber Mostyn in a press release announcing the petition. "Acknowledging there is a problem is not enough. It's like a firefighter watching a building burn while warning us not to play with matches."
FDA has published a notice on its website about the issue. In it, the agency said it is aware of the allegations about counterfeit raw material and that Boston Scientific will be running safety and effectiveness tests:
"We are currently not aware that the alleged counterfeit raw material contributes to adverse events associated with these products. It is not uncommon for a firm, based on its own appropriate evaluation of potential suppliers and raw material, to change the source of a raw material after the device has been cleared by the FDA, and such a change often does not require FDA premarket review. However, in light of the allegations, Boston Scientific will conduct additional testing relevant to the safety and effectiveness of the finished product . . . We expect that this testing will take several months to complete."
FDA had not responded with further comment at presstime.
The petition asserts that employee emails support its allegations, quoting one employee email that reads in part, "For this material, we have lost all of the original paperwork so we can’t prove that was legally imported in the country. and if we don’t get rid of the original bags or the writing on the bags when we claim they are from China (we have to say they are from China since we don’t have the original paperwork attached), if it is caught by custom, we will be in trouble. Therefore the shipper told me it is better to consider to re-pack all of them or find a way to get rid of all of the words/writing on the bags." According to the petition, another employee responded with, "We can over bag, but we should not open bags and repack."
The petition also alleges that Boston Scientific knew there were major differences between the Chinese material and Marlex but used it anyway. In addition, the petition claims that the Chinese material had high levels of selenium, which is toxic and if converted into selenic acid with hydrogen peroxide exposure, can speed mesh degradation and damage tissue and nerves.
In its statement, Boston Scientific explained, "Changing suppliers of raw materials is not unusual for medical device companies, and when Boston Scientific makes such a change, we follow the processes required by our quality system. In 2011, we located a new supplier of Marlex resin. Upon doing so, we put samples of the resin through a rigorous battery of tests to demonstrate equivalency. In addition, we conducted extensive mechanical tests to ensure our mesh products manufactured with the newly sourced material met product specifications."
Mostyn also made these allegations when it filed a federal racketeering lawsuit against Boston Scientific and three other companies in January. "Because the FDA has primary jurisidiction over the safety of medical devices and authority to issue recalls, the judge in that case has suspended legal action to give the regulatory agency time to act," the press release announcing the petition this week explained.
Boston Scientific's statement concluded, "We have the highest confidence in the safety of our mesh devices. We have shared our test data with the Food and Drug Administration (FDA), and are fully cooperating with the agency's requests for information as part of our ongoing discussions. Additionally, we have offered to conduct further biocompatibility and chemical characterization testing to complement the results from existing tests. This entire process is expected to take several months, depending on the individual tests. In the interim, we encourage physicians to continue to have confidence in our products and make the best, informed decisions with their patients."
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Apr 1, 2016 | Mesh Medical Device News Desk
The U.S. Food and Drug Administration (FDA) acknowledged today it is aware that some of Boston Scientific’s (BSC) urogynecologic surgical mesh may be made from counterfeit raw material.
This is the first time the agency has responded to a federal racketeering lawsuit filed by Mostyn Law of Houston, alleging Boston Scientific was involved in a “scheme” to defraud regulators in both China and the U.S. by smuggling 37,000 tons of raw polypropylene resin into the U.S. without any oversight from regulators.
The composition of any surgical mesh made from that counterfeit polypropylene resin remains unclear to the FDA which will rely on Boston Scientific to test its own mesh products.
He is referring to the company’s previous assurances to the FDA that its sourced resin was Marlex, the company’s trade name for its polypropylene.
CITIZEN PETITION
The FDA warning comes one day after the Mostyn Law firm filed a citizen petition which contained previously sealed documents laying out how Boston Scientific allegedly brought the resin into the country.
The evidence shows Boston Scientific sought distributors of raw polypropylene through a website called Alibaba.com, not unlike an ebay for raw materials. The company feared a shortage of
Marlex, its polypropylene mesh, would cost $120,000,000 in annual profits after U.S. supplier Phillips said it was not interested in doing business with BSC at any price and would no longer supply raw polypropylene pellets used to be fashioned into a mesh material for implantation in the pelvic floor for support.Included in the petition is a lab report from Cambridge Polymer Group of Boston, Mass. completed for Boston Scientific October 13, 2011. It compared three samples of polypropylene pellets. Using Plasma Spectroscopy it found the samples contained high levels of selenium.
Selenium is a trace element essential in small amounts but toxic at high levels, according to the Linus Pauling Institute (here). Selenium toxicity has been noted in China. Symptoms include hair and nail brittleness and loss, gastrointestinal disturbances, skin rashes, garlic breath, fatigue irritability and neurologic disorders.
The samples differed in trace minerals as well as debris of small fiber particles on some resin pellets.
The sealed documents were just released last week and the defendant company “fought us every step of the way,” Mostyn says.
The FDA says it’s not aware of any complications that have occurred as a result of raw polypropylene resin. It will review the findings of Boston Scientific when it finishes its evaluation of the composition of its mesh made from the counterfeit polypropylene resin, which should take several months to complete.
In the interim, the FDA says the public should be aware of this investigation.
Mostyn believes sourcing raw polypropylene form China may extend beyond Boston Scientific, though he would not elaborate. In March 2010, the FDA issued a warning that counterfeit surgical mesh marketed by C.R. Bard was in the marketplace. See the FDA warning here.
RICO LAWSUITOn January 12, 2016, West Virginia resident Teresa Stevens filed a class action lawsuit alleging Racketeer Influenced and Corrupt Organizations Act (RICO) and filed a motion asking Judge Goodwin to stop the sale of Boston Scientific pelvic mesh. Judge Goodwin denied the motion and requested the FDA to look at the issue citing the Doctrine of Primary Jurisdiction (here).
Stevens was implanted with a Boston Scientific Advantage pelvic mesh as are about 55,000 other women every year, says the plaintiff complaint.
During a meeting with FDA regulators in Washington D.C. on February 19th, Mostyn says they laid out the entire “scheme” to the FDA but “it was like talking to a blank wall.”
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