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Is the FDA’s 510(k) Loophole Responsible for 1000’s of Transvaginal Mesh Injuries?

A troubling number of reports have surfaced linking transvaginal mesh to serious side effects including erosion of the mesh into the vaginal tissue, infection, bleeding, pain, and recurrence of the urinary problems the devices were implanted to treat in the first place.

Many of the modern surgical mesh products used for the treatment of women’s urinary problems on the market today are based on Boston Scientific’s original ProteGen design, which was used to treat abdominal wall defects and hernias. By 2010, 168 transvaginal mesh devices were approved for sale under the U.S. Food & Drug Administration’s controversial 510(k) clearance process, a loophole that requires no clinical studies so long as the device in question is similar to one already on the market. Unfortunately, over the past several years, a troubling number of reports have surfaced linking transvaginal mesh to serious side effects including erosion of the mesh into the vaginal tissue, infection, bleeding, pain, and recurrence of the urinary problems the devices were implanted to treat in the first place.

Free Transvaginal Mesh Lawsuit Evaluation: If you or a loved one has been injured by a transvaginal mesh device, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the transvaginal mesh and we can help.

What’s the problem?

In 1976, Congress passed the Medical Devices Amendments, which defined the required steps for medical device manufacturers to gain approval from the FDA to sell their products on the U.S. market. This would later become known as the 510(k) approval process.

The FDA separates medical devices into three broad categories based on their potential side effects and the ability of post-market controls to manage them. With products that are classified as having a low to moderate risk (Class II), device manufacturers are only required to notify the FDA 90 days before the company brings them to market. Under 510 (k), Class II devices that are determined to be ‘substantially similar or equivalent’ to a product already on the market are granted approval without undergoing clinical tests. Since the process was first enacted in 1976, about 90% of medical devices have been approved through 510(k). One of the most controversial and widely-used medical devices approved under this process was transvaginal mesh.

Surgical mesh was first used in the 1950s to reinforce and support weakened soft tissue or bone. Then in the 1970s, gynecologists started using the material to treat pelvic organ prolapse (POP), a condition that occurs when the tissue that holds the pelvic bones together becomes weak and organs begin to bulge into the vagina. In the 1990s, surgical mesh began being used to treat stress urinary incontinence (SUI), a common problem in aging women characterized by the loss of urine at unexpected times. Although exact statistics are hard to come by, most experts estimate that about 500,000 women are implanted with transvaginal mesh to treat POP and SUI each year around the country.

Test results involving vaginal mesh side effects have been conflicting. It has been found that anywhere between 10 and 25% of recipients have suffered serious complications, with the most commonly reported side effects including:

  • Erosion of the mesh into the vaginal tissue
  • Infection
  • Bleeding
  • Extreme pain
  • Pain during sexual intercourse (dyspareunia)
  • Organ perforation (puncturing) from surgical tools during mesh implantation
  • Return of POP or SUI
  • Neuromuscular problems
  • Vaginal scarring/shrinkage
  • Emotional / psychological side effects

In 2008, the FDA issued its first warning to healthcare providers about the risks associated with the placement of surgical mesh for transvaginal purposes. At the time, the administration had received over 1,000 adverse event reports (AERS) involving transvaginal mesh. A growing body within the medical community has voiced concerns that the lack of safety data on transvaginal mesh is enough to warrant recalling the devices on a nationwide level. One of the main concerns centers around the FDA’s 510(k) loophole.

In July 2011, the Institute of Medicine released a report entitled “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years.” The report called on the FDA to junk 510(k) and require surgical mesh manufacturers to prove their devices are safe and effective. To date, thousands of transvaginal mesh lawsuits have been filed in courthouses around the country on behalf of women allegedly injured by transvaginal mesh side effects.

Do I Have a Transvaginal Mesh Lawsuit?

The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in transvaginal mesh lawsuits. We are handling individual litigation nationwide and currently accepting new injury cases in all 50 states.

Free Transvaginal Mesh Lawsuit Evaluation: If you or a loved one suffered a serious injury after being implanted with a transvaginal mesh device, you should contact our law firm immediately. You may be entitled to compensation by filing a transvaginal mesh injury suit and we can help.

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