Industry, Patient Advocates at Odds over Transvaginal Mesh Regulation

There’s little common ground between < "">transvaginal mesh device makers and patient advocates, according to a summary detailing last week’s two-day Food & Drug Administration (FDA) advisory panel meeting. While many patient advocates demanded that transvaginal mesh devices be recalled until their safety is more firmly established, industry representatives want the FDA to keep the status quo.

Transvaginal mesh manufacturers, including American Medical Systems, C.R. Bard, and Johnson & Johnson, have been named in hundreds of lawsuits filed by women who claim to have suffered painful and debilitating complications following implantation of the devices to repair pelvic organ prolapse. Earlier this summer, the FDA said in a safety communication that it had received 1,503 reports of serious complications associated with transvaginal mesh used in POP repair, including mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. The agency also said that its review had not seen any evidence that POP repair with transvaginal mesh offers any additional benefits compared to other treatment methods.

Last Thursday and Friday, the FDA’s Obstetrics and Gynecology Devices Advisory Panel met to discuss the safety of transvaginal mesh devices in POP repair. In advance of that meeting, FDA staff released an Executive Summary detailing the issues with the devices in this type of surgery. The Executive Summary proposed that transvaginal mesh products for POP repair be reclassified as Class III medical devices, and undergo the most stringent of testing prior to FDA market approval. Doing so would make transvaginal mesh devices ineligible for the FDA’s 510(k) approval process, which among other things, does not require human testing. The majority of advisors on the FDA panel backed the FDA staff proposal, and also agreed that the agency should require the manufacturers of transvaginal mesh devices currently on the market to conduct postmarketing studies to assess their safety and effectiveness in POP repair.

During the meeting, the advisors heard from patients, patient advocates and industry representatives. The views expressed ranged from requests that mesh for POP repair be banned due to safety concerns to arguments that POP repair without mesh would be a disservice to women.

According to a report from Bloomberg News, Johnson & Johnson and other makers of transvaginal mesh devices agreed that the products should be subjected to more studies. They also backed labeling changes to warn of potential risks. But they want transvaginal mesh to remain in the Class II, moderate risk category. During an interview at the hearing, for example, a director from Endo Pharmaceuticals claimed that a reclassification would be too burdensome for manufacturers.

Those on the other side of the argument included a physician speaking for the American Congress of Obstetricians and Gynecologists who told the panel that more clinical trials are needed to establish whether the benefits of transvaginal mesh devices outweigh their risk. According to Bloomberg, the group’s representative also pushed for a registry to follow patients already with implants.

At least one prominent consumer advocate had gone on record seeking a transvaginal mesh recall even before the meeting. In August, Public Citizen filed a petition with the FDA calling for such a recall, asserting that transvaginal mesh devices “offer no significant benefits but expose patients to serious risks and the potential for permanent life-altering harm.”

Yesterday, Parker Waichman LLP, a national law firm that represents people in lawsuits involving defective medical devices, issued a statement in support of the proposal to reclassify them as high risk. The firm also added its voice to those calling for a recall of currently marketed devices.

“In light of the staggering number of serious complications reported among women who have received transvaginal mesh devices for POP repair, Parker Waichman LLP urges the FDA to implement its proposal to reclassify these devices as soon as possible,” the statement said. “Parker Waichman LLP also calls on the FDA to order a recall of all transvaginal mesh devices currently being marketed for POP repair until their safety and effectiveness can be established.”

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