Boston Scientific Ordered by the FDA to Halt Sales of Gynecological Mesh

Boston Scientific and another transvaginal mesh manufacturer were ordered by the U.S. Food and Drug Administration (FDA) on April 16 to stop selling and distributing the products. The move comes in response to safety concerns regarding the surgical implants, which have been used in more than 2 million women. [1]

Transvaginal surgical mesh is used to repair weak or damaged tissue and provides support for women suffering from pelvic organ prolapse (POP). The condition occurs when muscles and tissues supporting the uterus, bladder, and rectum become weak, allowing one or more of the pelvic organs to drop or press into or out of the vagina. [1] [2]

Neither Boston Scientific nor the other company, Coloplast, have demonstrated the safety or efficacy of the devices, according to the FDA.

In a statement, Jeffrey Shuren, a physician and director of the FDA’s Center for Devices and Radiological Health, said:

“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.”

The agency reclassified the devices as high risk in 2016, requiring both companies to win the FDA’s approval under its most stringent review process to keep selling the implants. Tens of thousands of women have filed lawsuits alleging that transvaginal surgical mesh caused them life-altering pain or injury.

Read: Johnson & Johnson Sued Again over Transvaginal Mesh Marketing

The Mayo Clinic says that transvaginal mesh for POP repair can cause complications such as erosion and pain, infection, bleeding, pain during sex, organ perforation, and urinary problems. In many cases, these complications require further treatment, including surgery.

The percentage of transvaginal POP mesh procedures has declined in recent years amid warnings about their potential risks.

The medical device makers have 10 days to come up with plans for pulling the products from the market. [2]

Boston Scientific said it is “deeply disappointed by the FDA’s decision,” and that “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.”

Coloplast took a humbler approach to the FDA’s demand, saying in a statement:

“Patient safety is always our highest priority and we will work closely with the agency to understand its direction and determine next steps.”

Sources:

[1] CBS News

[2] Fierce Biotech