A new investigation by Consumer Reports sheds light on a number of dangerous medical devices, such as the DePuy ASR hip replacement and vaginal mesh implants, which received market approval by the U.S. Food and Drug Administration (“FDA”) without clinical testing. These devices ultimately resulted in patients suffering serious complications, such as a transvaginal mesh injury. The most troublesome aspect is that patients who received these devices may not be aware of the devices’ safety issues even after a recall. In order to rectify this widespread problem, in 2011, a panel from the Institute of Medicine recommended that the FDA should modify its medical device approval system because it fails to protect patient safety. However, Congress is currently debating a new law that would maintain the current system. “What they’re doing is conducting clinical trials on the American public,” said Dan Walter, a political consultant from Maryland whose wife suffered from one such defective device. Patients have little power to protect themselves under the current system, and worse, there is no systematic and certain way for governments, researchers or patients to learn about the dangers of the devices without reform.

Transvaginal Mesh Injury Requires One Woman To Undergo Multiple Surgeries

Consumer Reports told the story of Janet Holt from Floresville, Texas, who received a surgical mesh implant in 2007 and later suffered a transvaginal mesh injury. In the weeks after the surgery, Holt said, “I was in such pain I couldn’t sit, I couldn’t stand, and I could hardly walk.” Over time, the surgical mesh shifted its way out of the vaginal walls where it was implanted. Holt described the transvaginal mesh injury as akin to “open cigarette burns with each step you take. It’s complete torture.” The 54 year old woman had to undergo eight surgeries to adjust and finally remove the surgical mesh. The long term effect of her transvaginal mesh injury resulted in nerve damage in one leg.

The defective transvaginal mesh implant Holt received came on the market in the early 2000s. It was intended to support prolapsed organs, and was marketed to doctors in a “kit” with tools for insertion as an easier way to implement something that traditionally required advanced medical training. Since then, there have been many signs of the device’s failures, including:

  • thousands of adverse event reports,
  • women’s health and consumer health advocate warnings; and
  • hundreds of lawsuits filed against manufacturers of surgical mesh implants.

Despite these alarming signs of the device’s failures, the implants are still being sold and classified as “moderate risk” devices.

Investigation by Consumer Reports Questions FDA Device Approval Process

Lewis Wall, M.D., a professor of obstetrics and gynecology at Washington University in St. Louis told Consumer Reports, “You’re putting a foreign object into the pelvis through a contaminated space, so there’s a very high potential risk of infection. But there weren’t any clinical trials done with these products before they hit the market.” Transvaginal mesh was approved without testing because it was deemed “substantially equivalent” to a device that was already on the market—according to Consumer Reports, “An earlier mesh used to repair abdominal hernias that was sold as long ago as the 1950s.” The clearance process costs manufacturers a nominal user fee of $4,049, payable to the FDA. In August 2011, a consumer advocacy group, Public Citizen, petitioned the FDA to remove transvaginal mesh from the market out of concern for the number of women who experienced a transvaginal mesh injury, calling the device “a ‘poster-child’ example of the fundamental failure…to protect the public’s health and welfare.”

In January 2012–10 years after the first transvaginal mesh kits hit the market–the FDA finally ordered safety studies on the devices. Specifically, on January 5th, 2012, the FDA ordered 33 companies to conduct post-market safety studies of their transvaginal mesh devices. Currently, the agency is considering reclassifying vaginal mesh to include it in the highest risk category.

Transvaginal Mesh Injury Lawsuits Filed

Holt is now among hundreds of women who are filing vaginal mesh lawsuits. If you suffered from a transvaginal mesh injury, you may be entitled to compensation for your pain and suffering, lost wages, and medical expenses. Contact a lawyer today for a free and confidential case review. The lawyers at Bernstein Liebhard LLP have recovered over $3 billion on behalf of their clients, and are dedicated to protecting your legal rights and options.

Published April 11, 2012 by