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August 20, 2019

FDA halts sales of mesh implants for pelvic conditions after years of injury and complication reports

April 18, 2019
In this Dec. 20, 2018, photo, Dr. Jeffrey Clemons, a pelvic reconstructive surgeon, holds a sample of transvaginal mesh used to treat pelvic floor disorders and incontinence in women as he poses for a photo in Tacoma, Wash. (Ted S. Warren/AP)

The U.S. Food and Drug Administration (FDA) is telling the remaining two manufacturers of transvaginal mesh implants used to treat pelvic collapse to halt production immediately, citing the potential for complications and injury.

The move comes after the FDA in 2016 decreed transvaginal mesh a high-risk product and gave the two remaining manufacturers, Boston Scientific and Coloplast, time to demonstrate “a reasonable assurance of safety and effectiveness for these devices.”


The two companies failed to do so, the FDA said in a statement on Tuesday, and now have 10 days to produce a plan for pulling the devices from the market.

The order applies solely to transvaginal mesh products used to cure pelvic organ prolapse (POP). Surgical mesh used to treat hernias, incontinence and other conditions are not affected, the Associated Press noted. The ban also does not apply to mesh products treating stress urinary incontinence.

POP occurs when the muscles and tissues supporting the uterus, bladder or rectum become weak, or loose, causing one or more of them to drop or press into or protrude from the vagina, according to the U.S. Department of Health & Human Services’ Office on Women’s Health.

The condition is most common in older women, especially white and Hispanic, the Office on Women’s Health said. In extreme cases, treatment can include surgery that uses either a woman’s own tissues, or synthetic mesh, to help repair the prolapse and buttress the pelvic-floor muscles that hold the organs in place.

Mesh can be implanted surgically either through the abdomen or the vagina, or transvaginally. It’s the transvaginal pelvic mesh that the FDA is halting. That mesh procedure has been in place since the 1990s.

Complications can include pain, bleeding and infection. The mesh has also been known to shift and puncture internal organs or the abdominal wall, issues that themselves can require surgery to fix, according to the Mayo Clinic.

The complications have generated lawsuits from more than 100,000 people against manufacturers, with multimillion-dollar settlements.

Susan Harrison of Lawrenceville, Ga., left, and Vea Gaby of Athens, embrace after telling their stories about complications from having surgical mesh placed in their pelvic cavities following an interview in their attorney's office, Monday, Jan. 28, 2013, in Athens, Ga.
Susan Harrison of Lawrenceville, Ga., left, and Vea Gaby of Athens, embrace after telling their stories about complications from having surgical mesh placed in their pelvic cavities following an interview in their attorney’s office, Monday, Jan. 28, 2013, in Athens, Ga. (David Goldman/AP)

“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these pre-market applications, and we couldn’t assure women that these devices were safe and effective long term,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, in the agency’s statement. “Patient safety is our highest priority, and women must have access to safe medical devices that provide relief from symptoms and better management of their medical conditions. The FDA has committed to taking forceful new actions to enhance device safety and encourage innovations that lead to safer medical devices, so that patients have access to safe and effective medical devices and the information they need to make informed decisions about their care.”

Women who are not having issues with their implants should continue to undergo regular checkups but do not need to take any action if they are not having symptoms, the FDA said.

Coloplast, a Danish company, did not comment. But Boston Scientific said it stood by its products and that the decision would hurt women.

“The inaccessibility of these products will severely limit treatment options for the 50% of women in the U.S. who will suffer from pelvic organ prolapse during their lives,” spokeswoman Kate Haranis told the Minneapolis Star Tribune.

But patient advocates said the FDA needed to do more, and should have done it sooner.

“These mesh devices were on the market for over 20 years, leaving tens of thousands of women to live with permanent disabilities and disfigurement,” said Amanda Dykeman, the Illinois-based founder of Medical Device Problems, in a statement to the Star Tribune. “We feel the announcement, while a step in the right direction, also does not go far enough; it does not address other mesh devices that are causing similar life-altering injuries.”


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