Our Practice Areas

To increase public safety, FDA tightens regulation of transvaginal mesh

Federal regulators have increased the safety risk assessment of transvaginal mesh used to repair pelvic organ prolapse.

The federal government just took action to keep women safer by strengthening regulation of transvaginal mesh. Specifically, surgical mesh will now be more tightly regulated when used to prevent pelvic organ prolapse, called POP, by permanently implanting the mesh inside the body via vaginal insertion.

We previously published an article about the U.S. Food and Drug Administration's May 2014 proposal to reclassify transvaginal mesh to Class III, the classification of highest risk. The FDA is the federal agency responsible for, among other things, keeping the public safe by regulating medical devices like transvaginal mesh.

On January 4, 2016, the agency issued a news release that it had ordered the classification change from Class II to Class III as well as requiring that these devices receive premarket approval or PMA.

The FDA designates each medical device into one of three classes:

  • Class I is for lower risk devices that have the fewest regulatory controls.
  • Class II is for moderate risk devices that require higher regulatory control.
  • Class III is for medical devices that present the highest risk to public health and require the most government regulation. Notably, the FDA must approve Class III devices for release to market, called premarket approval or PMA for short.

As more evidence about the safety of a device comes to light, the agency may move to reclassify a medical device, which is what happened after serious health dangers of transvaginal mesh were reported to the FDA. The agency received a "significant increase in the number of reported adverse events" when mesh was used for transvaginal POP.

POP is suffered by women whose pelvic floors collapse because of weak or damaged tissue, causing organs (bladder, uterus or bowel) to drop into the vagina. This condition may cause constipation, incontinence, constant urinary pressure, back pain and other problems. Transvaginal mesh is utilized to support the dropped pelvic floor and weakened muscles, but the FDA has received thousands of complaints of medical complications associated with this use of the mesh such as:

  • Infection
  • Bleeding
  • Severe pain
  • Painful intercourse
  • Perforation of surrounding organs by mesh
  • Urinary difficulty
  • And more

The agency believes that its new rule that manufacturers get premarket approval will force makers to address the safety problems patients have reported. The five manufacturers already selling the device have 30 months to retroactively submit their applications for PMA.

It is hoped that the FDA's actions will result in a safer medical device for female patients with pelvic organ prolapse. In the meantime, however women have been and continue to be seriously injured from transvaginal use of mesh for POP repairs. A substantial number of product liability lawsuits have been filed against manufacturers for injury from these allegedly defective or dangerous products.

Any woman injured by transvaginal mesh should speak with a lawyer as soon as possible to understand her legal rights and potential legal remedies, including a product liability or personal injury lawsuit for damages. Legal counsel who have handled surgical mesh cases will be familiar with the medical and legal issues, including how to undertake the necessary investigation and the use of expert witnesses.

From offices in Stamford and Bridgeport, the lawyers at Tooher Wocl & Leydon LLC represent clients in Fairfield County and throughout the state of Connecticut injured by transvaginal mesh and in other personal injury matters.