FDA Takes Steps to Address Transvaginal Mesh Problems
More than five years after first highlighting the risks of problems with transvaginal mesh, the FDA has finally taken the much-needed step of reclassifying the controversial products as “high-risk” medical devices.
Unfortunately, this will do little to help the tens of thousands of women who suffered painful and disfiguring injuries after receiving transvaginal mesh, which likely could have been prevented if manufacturers had conducted rigorous studies on the products before the mesh was first introduced.
More than 50,000 women throughout the United States are now pursuing transvaginal mesh lawsuits against more than a half-dozen different manufacturers of these dangerous and defective products, and the number of complaints continues to increase every month involving claims brought by women who suffered problems like:
- Erosion of the Mesh into the Vagina
- Injuries to the Uterus
- Organ Perforation
- Urinary Problems
The transvaginal mesh lawyers at Saiontz & Kirk, P.A. have been representing women throughout the United States involving these products since 2008. Although manufacturers should have been required to fully research and evaluate these products before they were ever approved, it is good to see the FDA finally taking steps to close the back-door that has been available for manufacturers to introduce these inherently dangerous products.
Long Road to Address Transvaginal Mesh Risks
This week, the FDA announced that it plans to reclassify transvaginal mesh from Class II moderate risk medical devices to Class III high-risk medical devices, which will prevent manufacturers from introducing new products through the controversial 510K fast-track approval process.
Previously, manufacturers were only required to show that their mesh products were “substantially equivalent” to another approved medical device. However, a growing chorus of critics, including some within the FDA, have pointed to transvaginal mesh in recent years as evidence that the 510k process allows dangerous devices to reach patients.
The decision comes after years of warning signs, and raises many questions about why it took the FDA so long to address the risk of transvaginal mesh problems.
- October 2008: The FDA issued a public health notification to warn about reports involving more than 1,000 women who experienced severe complications from transvaginal mesh products sold by nine different companies, including infection, pain, urinary problems and bowel, bladder or blood-vessel perforations. The agency also indicated at that time that women reported the need for additional surgery to remove mesh that had eroded into the vagina, recommending that physicians ensure patients are aware of the potential transvaginal mesh risks.
- July 2011: The FDA issued an updated safety communication about transvaginal mesh ahead of an independent advisory committee convened to look at the safety and effectiveness of the devices for treatment of pelvic organ prolapse (POP) and female stress urinary incontinence (SUI). At that time, the FDA indicated that transvaginal placement of the surgical mesh carried a high risk, and suggested that there was no evidence that vaginal mesh provided any benefits when compared to traditional treatments for POP.
- August 2011: The prominent consumer group Public Citizen filed a petition with the FDA calling for a transvaginal mesh recall and ban on marketing of all available products to protect women from the risk of serious complications.
- January 2012: The FDA sent letters to 33 different manufacturers of transvaginal mesh products, including Johnson & Johnson’s Ethicon subsidiary, American Medical Systesms (AMS), Boston Scientific and C.R. Bard, calling for the companies to conduct post-marketing studies to evaluate the safety of the devices.
Rather than conducting the required studies over the past two years, several manufacturers chose to withdraw their vaginal mesh products from the market.
Transvaginal Mesh Lawsuits
The product liability lawyers at Saiontz & Kirk, P.A. are continuing to review new cases for women who experienced problems after receiving transvaginal mesh or bladder sling products. As a result of the manufacturers’ failure to adequately research and evaluate the safety and efficacy of these products, financial compensation may be available through a transvaginal mesh settlement.
To review a potential claim for yourself or a loved one who has suffered an injury, request a free and confidential consultation and claim evaluation. All cases are handled on a contingency fee basis, meaning there are no fees unless a recovery is obtained and never any out-of-pocket expenses.