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FDA cracks down on transvaginal mesh devices amid safety concerns
Jan 5, 2016 | Fierce Medical Device
By Emily Wasserman
The FDA is doubling down on transvaginal mesh devices, responding to growing safety concerns by slapping the products with its most serious designation and calling for additional information from manufacturers before signing off on related devices. -
FDA's Pelvic Mesh Scrutiny May Have Limited Impact In MDL
Jan 6, 2016 | Law360
By Sindhu Sundar
The U.S. Food and Drug Administration's view that certain transvaginal meshes are now high-risk medical devices that must meet strict safety assessments appears to support mesh implant patients in federal multidistrict litigation, but experts say defendants can still blunt its impact in the courtroom by trying to block juries from hearing about the development. -
FDA cautions use of mesh for pelvic organ prolapse
Jan 5, 2016 | Health 24
The U.S. Food and Drug Administration has strengthened rules regarding the use of vaginal mesh implants to treat pelvic organ prolapse in women. -
FDA Tightens Controls on Transvaginal Mesh
Jan 5, 2016 | Courthouse News Service
By Ramona Young-Grindle
As reports of serious complications continue to rise, the Food and Drug Administration has issued two orders to manufacturers to strengthen requirements for transvaginal surgical mesh. -
Transvaginal Mesh Is the Stuff of Nightmares
Jan 6, 2016 | The Daily Beast
By Samantha Allen
Thousands of lawsuits and a serious FDA warning may have this controversial product off the market by 2019. The FDA has warned women about the risks of transvaginal mesh for years. Now, the agency is finally taking direct action to limit the use of this popular but potentially dangerous product. -
FDA reclassifies mesh for TVT
Jan 6, 2016 | Modern Medicine Network
By Judith M. Orvos
Surgical mesh for pelvic organ prolapse (POP) is a class III or high-risk medical device requiring premarket approval application (PMA) following new action by the Food and Drug Administration (FDA). -
FDA teams up with medical device industry to write 21st Century Cures Act
Jan 5, 2016 | Health News Review
By Trudy Leiberman
Shortly before Christmas Inside Health Policy, a trade pub that covers the drug industry and related topics,revealed the real power behind the rapid journey of the 21st Century Cures Act through the House of Representatives last year. -
FDA Finalizes Tougher Stance on Transvaginal Mesh
Jan 5, 2016 | Medical Device and Diagnostic Industry
By Marie Thibault
FDA is upclassifying surgical mesh used in transvaginal repair of pelvic organ prolapse from Class II to Class III devices and requiring makers to submit PMA applications.
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FDA cracks down on transvaginal mesh devices amid safety concerns
Jan 5, 2016 | Fierce Medical Device
By Emily Wasserman
The FDA is doubling down on transvaginal mesh devices, responding to growing safety concerns by slapping the products with its most serious designation and calling for additional information from manufacturers before signing off on related devices.
The agency is reclassifying surgical transvaginal mesh devices for pelvic organ prolapse (POP) from Class II to Class III, which is typically reserved for high-risk devices. Regulators are also requiring that manufacturers submit a premarket approval (PMA) application "to support the safety and effectiveness" of their products, the FDA said in a statement.
Companies that already have products on the market have 30 months to submit a PMA application, and manufacturers with new products will need to submit a PMA before the FDA gives its stamp of approval. But the latest requirements don't apply to mesh products used to treat other conditions such as urinary incontinence.CDRH's William Maisel
Heightened scrutiny for the devices "will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse," William Maisel, head of the FDA's Center for Devices and Radiological Health, said in a statement. And the agency plans to keep up its oversight, saying that it will "continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures," Maisel said.
The latest action builds on the FDA's previous attempts to crack down on mesh devices. The agency has gotten "thousands" of reports of complications related to mesh for transvaginal POP repair, regulators said in a statement, including severe pelvic pain, pain during intercourse, bleeding and urinary issues if the mesh erodes into surrounding tissues. Taking this into consideration, the FDA has recently beefed up its oversight of the products.
In 2008 and 2011, the FDA issued safety communications to doctors and consumers about a spike in adverse event reports tied to mesh used for urogynecological procedures. Regulators also convened a panel of experts in September 2011 to discuss how it should regulate transvaginal mesh devices. The panel's recommendations prompted the agency to order manufacturers to conduct postmarket surveillance studies for the devices. In 2014, the FDA laid out its plan to reclassify the devices as Class III and to require companies making the products to submit a PMA application.
Meanwhile, women who suffered from faulty mesh products continue to strike back at manufacturers of the devices. Industry giants such as Johnson & Johnson ($JNJ) and Boston Scientific ($BSX) are facing thousands of suits from women who claim that the company's devices caused them pain and injury, scoring few victories along the way. In April, Boston Scientific shelled out $119 million to settle about 3,000 cases over mesh products.
Other companies including Endo International ($ENDP) are taking a different route, settling all outstanding rather than battling it out with plaintiffs in court. In 2014, Dublin-based Endo added $400 million to its legal stockpile to settle "substantially all" of suits regarding mesh products sold by its American Medical Systems (AMS) unit.
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FDA's Pelvic Mesh Scrutiny May Have Limited Impact In MDL
Jan 6, 2016 | Law360
By Sindhu Sundar
The U.S. Food and Drug Administration's view that certain transvaginal meshes are now high-risk medical devices that must meet strict safety assessments appears to support mesh implant patients in federal multidistrict litigation, but experts say defendants can still blunt its impact in the courtroom by trying to block juries from hearing about the development.
The FDA on Monday finalized its April 2014 proposal to reclassify transvaginal mesh treatments for pelvic organ prolapse as Class III medical devices that must undergo the agency's rigorous premarket approval process.
While the decision may seem like an advantage for the patients, defense attorneys say manufacturers can plausibly argue that it is irrelevant to the MDL and fight to bar the plaintiffs from introducing it as evidence at trials. This is particularly likely in light of a Fourth Circuit appeal in the litigation, in which the appeals court is considering whether evidence about FDA clearance of the devices was rightly excluded from the first bellwether trial in the MDL.
"In normal circumstances, a device maker defending these cases wants to be able to explain that they complied with all applicable FDA regulations. Otherwise, it wouldn't be fair," Peter Goss of Blackwell Burke PA said.
"If the plaintiffs took the position in that case that FDA clearance of the device is irrelevant, and it is upheld, defendants can argue that that the subsequent change to the FDA's classification to the device shouldn't be relevant either," he added.
The appeal centers on a suit by plaintiff Donna Cisson, who in August 2013 won the MDL's first bellwether trial, in which she had alleged she had been injured by C.R. Bard Inc.’s Avaulta Plus transvaginal mesh device. Bard appealed the verdict to the Fourth Circuit, arguing that the lower court had wrongly excluded evidence about the FDA’s approval of its product under the 510(k) premarket notification program meant for Class II medical devices, which are considered to be moderate-risk devices.
The lower court had sided with Cisson in finding that the agency’s 510(k) clearance of the product is not relevant to her case because that clearance doesn’t involve safety assessments — it considers only whether a device is “substantially equivalent” to a device already on the market.
Defense and plaintiffs attorneys disagree about the potential impact of this Fourth Circuit appeal on other MDL plaintiffs’ ability to reference the FDA’s views on the devices.
On one hand, defense attorneys say if the Fourth Circuit finds that the FDA clearance was not relevant to Cisson's suit, courts presiding over future bellwethers — in federal or state court — would be similarly inclined to exclude from future trials the agency's latest decision to increase the risk classification of the transvaginal mesh devices.
Meanwhile, plaintiffs attorneys disagree that the appeals court's decision would have such a uniform impact on bellwether trials. They argue that courts will continue to decide on the admission of FDA-related evidence on a case-by-case basis.
Jayne Conroy of Simmons Hanly Conroy LLC, who is part of the plaintiffs’ steering committee in the mesh MDL in West Virginia, said she believes that any decision by the Fourth Circuit upholding the status quo may not carry much weight beyond the Cisson case.
"The MDL court has the discretion to do different things with different fact patterns, such as when a product was implanted, extracted and so on," she said. "I'd be very surprised to see the Fourth Circuit have the ability to make a blanket ruling with regard to what kind of FDA approval plaintiffs could talk about."
Plaintiffs attorneys are taking a cautious view on whether the agency’s move can directly bolster their cases, in which women implanted with the device claim that it has caused serious injury and that manufacturers did not sufficiently warn doctors about the risks. This is especially true since courts will consider manufacturers’ conduct based on the regulatory climate at the time the devices were made and implanted and not on new actions by the FDA.
But Conroy, whose firm represents some 20,000 plaintiffs in the litigation, said that the patients would likely use the FDA decision to hit back at any potential arguments by manufacturers that the agency had not previously found the products unsafe.
Also, plaintiffs attorneys believe they can use the FDA’s new step to add some weight to their arguments in court about the seriousness of the products' risks.
“It's significant that the FDA made this decision because it's what plaintiffs have been arguing all along — that these devices are risky and it's why companies need to have significant research behind them before they market them," Conroy said.
The case is Cisson et al. v. C.R. Bard Inc., case number 2:11-cv-00195, in the U.S. District Court for the Southern District of West Virginia. The MDL is In re: C.R. Bard Inc. Pelvic Repair System Products Liability Litigation, case number 2:10-md-02187, in the same court. -
FDA cautions use of mesh for pelvic organ prolapse
Jan 5, 2016 | Health 24
The U.S. Food and Drug Administration has strengthened rules regarding the use of vaginal mesh implants to treat pelvic organ prolapse in women.
Problems are common
The devices were reclassified on Monday from a "moderate" to "high" risk category.
Manufacturers must now submit pre-market approval applications to the FDA to help the agency better assess the implants' safety and effectiveness.
Pelvic organ prolapse involves a weakening or stretching of internal structures that support organs such as the bladder, bowel anduterus.
It can happen in women after childbirth, a hysterectomy or menopause. It can cause pelvic pain, constipation and urinary leakage, and often affects sexual activity.
Surgeons have long used the mesh implants to reinforce weakened pelvic floor muscles and repair pelvic organ prolapse.
But, problems afterwards such as pain, infection, bleeding, urinary problems and pain during intercourse are common, the agency said.
"These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse," Dr William Maisel, deputy director of science and chief scientist at the FDA Centre for Devices and Radiological Health, said in an agency news release.
"We intend to continue monitoring how women with this device are faring months and years after surgery through continued post-market surveillance measures," he added.
The updated requirements apply to surgical placement of the mesh implants through the vagina(transvaginal) to treat pelvic organ prolapse.
The new rules do not apply to other uses of surgical mesh.
Makers of transvaginal mesh implants already on the market now have 30 months to submit pre-market approval applications, while makers of new devices must submit an application before they can be approved for sale in the United States, the FDA said.
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FDA Tightens Controls on Transvaginal Mesh
Jan 5, 2016 | Courthouse News Service
By Ramona Young-Grindle
As reports of serious complications continue to rise, the Food and Drug Administration has issued two orders to manufacturers to strengthen requirements for transvaginal surgical mesh.
The FDA's orders reclassify these medical devices from class II, moderate-risk devices, to class III, high-risk devices, and require manufacturers to submit a premarketapproval application to enhance the safety and effectiveness of surgical mesh used for transvaginal, or through the vagina, repair of pelvic organ prolapse, which is believed to be less invasive than abdominal surgery.
The mesh is designed to treat conditions where organs in the pelvis, such as the bladder or bowel, drop (or prolapse) from their normal placement and push into the walls of the vagina. The condition can occur from muscles stretching during childbirth, or after a hysterectomy or menopause. Estrogen, which helps with collagen formation when levels are normal, can contribute to weakening of supportive tissues as levels drop with age or due to surgery.
The mesh device is also used to treat an associated condition called 'stress incontinence,' which can cause bladder leakage when coughing, sneezing, laughing or during exercise, again due to loss of muscle strength.
The new FDA directives only apply to mesh used for these two applications. Surgical mesh has been used since the 1950s for abdominal hernias, and this use is not affected by these new orders.
Transvaginal uses began in the 1990s, and the mesh was cleared for use as a class II moderate-risk device in 2002, according to the agency's announcement.
By October 2008, the FDA issued an alert to practitioners that it had received over one thousand reports of complications from mesh manufacturers over a three year period, which included vaginal erosion, infection, pain, urinary problems, and perforations of the bladder, bowel or blood vessels. At that time, nine manufacturers were making the mesh.
The agency updated its notice to practitioners in July 2011 to specify that the complications were "not rare," as an additional 2,874 complication reports were received in an intervening two-year period.
The agency's update in July 2013 included three deaths associated with the mesh implants due to perforations.
A November 2014 U.S. Judicial Panel report indicated more than 55,000 pending actions at the U.S. District Court level against six manufacturers of the device.
Under the new FDA orders, the five manufacturers currently marketing this transvaginal device will have 30 months to submit a premarket approval for devices that are already on the market. Manufacturers of new devices must submit a premarket approval before those devices can be approved for marketing. The manufacturers either declined to comment, or did not immediately respond to requests for comments.
"These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse," William Maisel, M.D., M.P.H., deputy director of science and chief scientist for the FDA's Center for Devices and Radiological Health, said. "We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures."
Both orders are effective Jan. 5, 2016. -
Transvaginal Mesh Is the Stuff of Nightmares
Jan 6, 2016 | The Daily Beast
By Samantha Allen
Thousands of lawsuits and a serious FDA warning may have this controversial product off the market by 2019.The FDA has warned women about the risks of transvaginal mesh for years. Now, the agency is finally taking direct action to limit the use of this popular but potentially dangerous product.
In a press release on Monday, the FDA announced that the surgical mesh, used to treat pelvic organ prolapse (POP), will be reclassified as a class III or high-risk medical device. In addition, manufacturers will have to receive premarket approval (PMA) for safety and effectiveness to keep selling the product.
“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” said Dr. William Maisel, deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health. “We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”
POP is a common condition in which weakened pelvic floor muscles—whether caused by aging, childbirth, a hysterectomy, or another risk factor—allow pelvic organs like the bladder, bowels, or uterus to descend into the vagina, causing pelvic pain, problems with intercourse, and urinary issues. Estimates of its prevalence vary but a 2002 study in the American Journal of Obstetrics and Gynecology found POP in over 40 percent of women over 60 who had not had a hysterectomy.
In 2002, surgical mesh was cleared by the FDA as a class II or moderate-risk treatment for reinforcing the pelvic floor muscles and permanently repairing POP. That was before the agency received “thousands of reports” about adverse events associated with the product.
Those risks, which the agency first cautioned patients about in 2008, include but are not limited to severe pelvic pain, infection, bleeding, organ perforation, urinary problems, and vaginal scarring. That year, the FDA reported that they had received “over 1,000” reports of these adverse events.
By 2011, when the FDA issued a second warning, they had received nearly 2,000 more reports. In bold print in that year’s safety communication, the agency noted that these serious complications are “not rare”—a change from their 2008 reporting. The most common complication, they noted, was the erosion of mesh through the vagina, which can require multiple surgeries to resolve, if it can be resolved at all. Providers and patients alike were warned to “be aware of the risks” before pursuing mesh-based treatments.
“Recognize that in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications,” the FDA told health care providers.
As transvaginal mesh manufacturers were hit with thousands of lawsuits, the FDA placed them under further scrutiny as well, initiating the postmarket surveillance that would eventually lead to the agency’s most recent orders. By mid-2014, there were nearly 60,000 pending transvaginal mesh lawsuits.Scam targeting woman who received transvaginal mesh surgeryWGHP - Greensboro, NC
Now, if manufacturers want to keep making this mesh, they have a 30-month deadline to submit their PMA. It is, at last, a bold move to limit a treatment that was becoming increasingly popular even as the FDA warned of the serious risks associated with it.
A June 2015 study published in the BMJ examining POP-related surgeries in New York found that mesh use actually increased by 44.7 percent from 2008 to 2011.
“Despite multiple warnings released by the FDA since 2008, use of mesh in pelvic organ prolapse surgery continues to grow,” the authors concluded, adding that this increase was taking place “even three to four years after regulatory alerts.”By mid-2014, there were nearly 60,000 pending transvaginal mesh lawsuits.
POP-related surgeries are big business. In the United States, there are over 300,000 such surgeries annually, costing over $1 billion. But although mesh became widely perceived as a “quick fix” treatment option for POP after its introduction in the 1990s, it is far from the only way to manage this common condition, even in the operating room.
As the American Academy of Family Physicians(AAFP) notes, some of the symptoms of POP, such as urinary problems, can be counteracted with Kegel exercises. Even severe instances of POP can be treated with a pessary, a removable and washable rubber device inserted into the vagina that keeps pelvic organs in place.
A pessary, as a 2010 study in the AAFP’s journal noted, “can be used in almost all circumstances when a nonsurgical option is desired,” even though it has traditionally been seen as a short-term solution.
Pessaries aside, there are non-mesh surgical options that may carry less risk while being just as effective. The 2015 BMJ study found that non-mesh surgeries were associated with less risk of reintervention within a year in patients under 65.Get The Daily Beast In Your InboxSUBSCRIBEFollow The Daily BeastAnd in 2012, Dr. Diane Mitchell, assistant director for science at the FDA’s Center for Devices and Radiological Health, said in a Medscape broadcast, “Postmarketing data indicate that repair of POP with surgical mesh is no more effective than POP repair with sutures alone, particularly for certain types of prolapse.”
“Patients who undergo POP repair with mesh are often subject to complicationsnot experienced by patients who undergo surgery without mesh,” she emphasized, noting that these complications can be “permanent and life-altering.”Unless the five manufacturers currently making transvaginal mesh can document its safety, the product will be gone in 2019 and listed as high risk by the FDA until then. This could be the death knell for one of the most litigated medical products still in use today.
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Jan 6, 2016 | Modern Medicine Network
By Judith M. Orvos
Surgical mesh for pelvic organ prolapse (POP) is a class III or high-risk medical device requiring premarket approval application (PMA) following new action by the Food and Drug Administration (FDA). The agency issued two final orders about the product after giving numerous warnings about their safety to physicians and patients over an 8-year period.
FDA previously considered surgical mesh for POP a class II medical device, meaning that it was moderate risk. Through the rigorous PMA pathway, manufacturers will now be required to demonstrate the safety and efficacy of the product and address concerns about its association with severe pelvic pain and organ perforation. The orders apply only to surgical mesh marketed for transvaginal treatment (TVT) of POP and not the device’s use for indications such as stress urinary incontinence or abdominal repair of POP.
Manufacturers of surgical mesh already on the market for the transvaginal indication will have 30 months to submit a PMA and a PMA must be submitted for any new mesh proposed for use for transvaginal repair of POP.
Surgical mesh was first approved as a class II device for transvaginal repair of POP in 2002. Since then, the FDA has received thousands of reports about complications associated with its use, including pain during intercourse, infection, and erosion into surrounding tissues. The agency issued safety communications about the device beginning in 2008 and proposed orders for the reclassification and PMA requirement in May 2014.
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FDA teams up with medical device industry to write 21st Century Cures Act
Jan 5, 2016 | Health News Review
By Trudy Leiberman
Shortly before Christmas Inside Health Policy, a trade pub that covers the drug industry and related topics,revealed the real power behind the rapid journey of the 21st Century Cures Act through the House of Representatives last year. It wasn’t the two dozen or sopublic forums held by the House Energy & Commerce Committee, the Act’s cheerleader-in-chief, or the drumbeat of messages to the media, or the shameless use of kids with rare diseases like Max and twinsBrooke and Brielle to tug on Congressional heart strings. It was the medical device industry working hand-in-glove with the Food and Drug Administration, a supposedly neutral regulator looking out for the public’s health and safety.
Documents and emails obtained by Inside Health Policy through a Freedom of Information request show that “CDRH [the FDA’s Center for Devices and Radiological Health] and AdvaMed [the device industry trade group] worked together on proposed language for most of the device provisions in 21st Century Cures.” Another document reveals that in preparation for the Senate’s own version of the Cures Act, AdvaMed and the FDA collaborated “to refine their regulatory strategy in a way that is agreeable to both parties.” Still another document that was prepared for a meeting with industry on August 7 noted that the trade association “thanked” Center director Dr. Jeffrey Shuren, “for meeting with AdvaMed regularly during the legislative process for getting the 21st Century Cures Act passed” and that the regulator and the lobbyists had “jointly written legislative text.” Besides AdvaMed, attendees at that meeting included the worldwide chairman of Johnson & Johnson’s medical device group and representatives from CVRx Inc., which makes implantable devices for high blood pressure and heart failure, and St. Jude Medical, a Minneapolis-based firm that bills itself as an inventor of breakthrough medical technologies.
It’s common, of course, for the regulator and the regulated to meet and discuss rules and even proposed legislation. That back and forth is as old as the FDA itself. But the communications unearthed by Inside Health Policy and then passed on in a piece by John Tozzi of Bloomberg News ten days later add up to an uncommonly cozy relationship with much of the public being none the wiser. They should be. The Cures Act, as I’ve pointed out, has profound consequences for millions of patients and would-be patients who have stents, uterine devices, pacemakers, wire mesh, and other medical equipment planted in their bodies to cure or diagnose illness.
The Act would allow the FDA to approve such devices not based on randomized controlled trials, the gold standard for determining safety and efficacy, but on less scientific, anecdotal evidence such as case histories. Scientific studies could take place after a device goes on the market, but many researchershave found problems with that approach. The Act would require the FDA to use third parties to review the safety and efficacy of devices when manufacturers make small changes as they often do. Currently the FDA does the review. The proposed changes weaken already weak rules for device approval that have led to thousands of complaints. Prominent among them are those from women who’ve taken to Facebook to discuss their injuries with the pelvic mesh.
Where were consumer advocates in this bill drafting process? Apparently not where it counted. Susan Wood, a former FDA assistant commissioner for women’s health, told Bloomberg News, “FDA’s drafting legislation in consultation with outside entities, whoever they are, strikes me as unusual. It gives a great deal more weight to the industry representatives on very specific legislation that affects both FDA and the industry, and others were not at the table.” That seems to be the point given the FDA’s bend-over-backward posture toward industry these days. A look at approvals of new drugs—those that are new molecular entities—illustrates the agency’s tilt. In 2015 the agency approved 45 new drugs — more than twice the number approved in 2005. A year ago a Forbes columnist proclaimed 2014 was “a good year for pharmaceutical innovation—the best, in fact, since the industry’s all time record of 1996.” The drive to get new drugs to market seems to be working, and the goal of the Cures Act is to do the same for devices.
Once again consumer advocates and others are asking, Whose interests does FDA represent anyway? Iposed that question to Dr. Hooman Noorchashm, a cardiothoracic surgeon who has been waging a grassroots campaign to get a device called the Power Morcellator off the market. The FDA-approved device is thought to have spread a hidden cancer when his wife underwent a procedure for fibroid tumors. This fall Noorchashm and his wife, also a physician, met with top FDA officials, including Shuren. Noorchashm told me he left the meeting with the sense that Shuren and his colleagues believe that “getting life-saving devices into the marketplace efficiently by streamlining with industry is the goal of their agency. It is not public health and patient safety.”
If the FDA favors fox-in-the-hen house regulation and isn’t interested in policing the safety of medical devices, where does that leave the public? As the agency moves ever closer to the side of those it regulates, stories like those that Chad Tehune wrote for the Los Angeles Times in late December show how relevant that question is. The Times as well as other news outlets have investigated deaths at U.S. hospitals caused by transmission of antibiotic-resistant bacteria that remain in endoscopes even after the devices are cleaned according to manufacturers’ directions. Over a three-year period, 21 people died and more than two dozen became ill from infections related to dirty scopes in Pittsburgh, Seattle, and Los Angeles. The FDA identified 10 outbreaks; seven involved a device made by Olympus, but the paper reported: “Even as patients died and others were put at risk, Olympus continued to sell the device and failed to warn U.S. hospitals that the scopes were tied to dangerous infections.”
Although Olympus did not tell hospitals about the dangers of their device, it did have to tell the FDA, but according to the paper those reports “suggested culprits other than its scope. The FDA issued no warnings based on those reports. Following federal regulations, it didn’t publicly identify the hospitals.” Maybe warning the public doesn’t matter much in today’s Washington. As the Cures Act collaboration illustrates, maybe advancing the interests of industry now takes priority over ensuring patient safety at the FDA.
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FDA Finalizes Tougher Stance on Transvaginal Mesh
Jan 5, 2016 | Medical Device and Diagnostic Industry
By Marie Thibault
FDA is taking a stricter approach to surgical mesh used in transvaginal repair of pelvic organ prolapse (POP), issuing two final orders reclassifying the devices from Class II to Class III and requiring manufacturers to submit PMA applications showing safety and effectiveness.
The orders follow numerous reports of adverse events and thousands of lawsuits filed against the devices in recent years. POP is a relatively common condition in women that takes place when the pelvic organs are no longer held in place by the pelvic floor. Sometimes caused by childbirth, POP can cause pelvic organs like the bladder to extend out of the vagina and may cause symptoms such as incontinence or pain during sexual intercourse. Surgical mesh was first cleared for this indication in 2002 as a Class II moderate-risk device, according to FDA.
"These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse," William Maisel, MD, MPH, deputy director of science and chief scientist for CDRH, said inan agency press announcement. "We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures."
FDA noted in its announcement that there are five manufacturers selling surgical mesh for use in transvaginal POP repair. These manufacturers will have 30 months—until July 5, 2018—to submit their PMA application. Any manufacturer looking to introduce new surgical mesh for transvaginal POP repair will first need to submit a PMA application for approval.
FDA originally proposed the PMA requirement and reclassification in May 2014.
This week's final orders cap off years of FDA communication on the issue. The agency published safety communications in 2008 and 2011 about increasing adverse event reports and held an advisory panel in September 2011 to gather expert recommendations. That panel's findings led to FDA's decision to reclassify the devices as Class III.
As explained in the FDA reclassification order, "FDA is reclassifying these devices based on the determination that general controls and special controls together are not sufficient to provide reasonable assurance of safety and effectiveness for this device. In addition, in the absence of an established positive benefit-risk profile, FDA has determined that the risks to health associated with the use of surgical mesh for transvaginal POP repair identified previously present a potential unreasonable risk of illness or injury."
In January 2012, FDA notified transvaginal mesh manufacturers that they must run postmarket surveillance studies on safety and effectiveness.
Manufacturers have been dealt tens of thousands of lawsuits related to transvaginal mesh. Ethicon counted 44,400 plaintiffs at the end of September while Boston Scientific noted over 30,000 cases or claims linked to transvaginal mesh for stress urinary incontinence and POP as of early November. In May 2015, a Delaware state court awarded$100 million in damages to a female plaintiff against Boston Scientific, but that was later reduced to $10 million.
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