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18 April 2019, 08:40 | Silvia Roy
Sales halted of pelvic mesh tied to injuries in women
Each year, thousands of women undergo transvaginal surgery to fix pelvic organ prolapse, a condition where weakened muscles and ligaments cause the pelvic organs to drop lower in the pelvis, creating a bulge or prolapse in the vagina.
In 2016, the agency had reclassified the mesh as class III or high risk, requiring its makers to submit and obtain approval from the FDA's most stringent device review pathway in order to continue marketing the products.
"That evidence was lacking in these premarket applications, and we couldn't assure women that these devices were safe and effective long term", Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a news release.
The FDA saidBoston Scientific Corp and Coloplast A/S did not demonstrate a reasonable assurance of safety and effectiveness of these devices in their premarket applications. Different organizations needed to expel their items from the market a year ago in light of the fact that they didn't submit required premarket endorsement applications, the FDA stated.
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Surgical mesh has been used by surgeons since the 1950s to fix abdominal hernias. It began to be used for abdominal fix by gynecologists in the 1970s, and for pelvic organ prolapse in the 1990s.
The FDA began slowly chipping away at mesh after it held its first committee meeting in 2011, and thousands of women have been waging a war against the device for years.
About 1 in 8 women in the US undergo some form of surgery to treat pelvic collapse problems, according to the FDA. Several other big manufacturers have discontinued this product.
Simply put, the remaining makers of the mesh devices - Boston Scientific and Coloplast - failed to prove the long-term safety or benefit of their devices, the FDA said in a news release.
In its statement, the FDA said it could no longer provide mesh patients "reasonable assurance of safety and effectiveness".
Boston Scientific filed two PMAs for its devices, the Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair System, and Coloplast filed a PMA for its device, Restorelle DirectFix Anterior. Implanting surgical mesh for abdominal fix of POP began in the 1970s.
"Too many women and men have been harmed by surgical mesh that was allowed on the market without any requirement for clinical trials", Zuckerman told Drugwatch. There is no need to have the mesh removed if patients are not having problems or symptoms. But they should notify their physicians if they have vaginal bleeding or discharge, pelvic or groin pain or pain during sex, the agency said.
They should also inform their health care provider if they have surgical mesh, especially if they're scheduled for another surgery or medical procedure. Women who were planning to have mesh placed transvaginally for the fix of POP should discuss other treatment options with their doctors. Regulators said use of the mesh targeted by their latest action has decreased in recent years due to safety concerns. The FDA order applies to mesh that is inserted through the vagina with a small incision, not mesh inserted through the abdomen with a larger incision. Most manufacturers elected to stop marketing surgical mesh for transvaginal fix of POP after receiving their 522 orders. In the 1970s, gynecologists began implanting surgical mesh for abdominal fix of pelvic organ prolapse and two decades later for the transvaginal fix of the condition, the FDA said.
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July 5, 2018: This was the deadline for applications to be filed for premarket approval for any surgical mesh marketed for transvaginal POP fix. Many manufacturers withdrew from the market amid the heightened regulatory scrutiny and the growing number of lawsuits.
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