Vaginal Mesh Implants Provide Glaring Example Of Flawed FDA 510(K)
On October 20, 2011, Bloomberg News published an article detailing the history of events leading up to the recent surge in vaginal mesh lawsuits currently facing manufacturers, such as Johnson & Johnson. These vaginal mesh implants are used to treat urinary incontinence, or pelvic organ prolapse, a condition in which the internal organs drop into the vagina. In addition to allegations against the manufacturers stemming from the defective medical design, the vaginal mesh lawsuits also point to the flawed fast-track 510(K) approval process, which allows manufacturers to circumvent rigorous clinical trials and testing by the U.S. Food and Drug Administration (“FDA”) in order to receive market clearance for their products. In order to utilize the expedited 510(K) process, medical device manufacturers are only required to show that their products are “substantially similar” to other devices available on the market.
How Did Johnson & Johnson’s Vaginal Mesh Implants Receive Market Approval?
Johnson & Johnson and other manufacturers received FDA clearance for their vaginal mesh implants based on their similarity to Boston Scientific Corp.’s ProteGen. Ironically, the vaginal mesh implants manufactured by Boston Scientific Corp. were pulled from the market after it was shown that they were unsafe for patient use. Yet, the Johnson & Johnson vaginal mesh implants have not been recalled. In fact, the FDA continued to approve vaginal mesh implants using the 510(K) process even after the Boston Scientific devices were recalled and pulled from the market due to numerous safety complaints. Amy Allina, a policy director at the National Women’s Health Network commented on the flawed FDA approval process, stating “If a first iteration is recalled, they don’t necessarily look at the second, third or fourth things that are based on that . . . The system is a mess.” Currently, manufacturers of vaginal mesh implants face more than 600 vaginal mesh lawsuits, which have been filed by women who claim that they were injured as a result of the defective devices. Additionally, the FDA estimates that almost 300,000 women received vaginal mesh implants in 2010. Therefore, the number of vaginal mesh lawsuits is expected to rise.
Defective Vaginal Mesh Implants Lead to Vaginal Mesh Lawsuits
In addition to explaining the flawed FDA approval process, Bloomberg News also provided personal accounts of individuals who have filed vaginal mesh lawsuits, including Lara Keeton and Marian Goldberg. “Once implanted, pieces of the synthetic fabric began flaking off, migrating through Keeton’s body and scraping against internal organs. . . It’s like removing gum from your hair . . . You can never get it all out.” Since Keeton’s original vaginal mesh implant in 2001, she has undergone 17 medical procedures, including five surgeries to remove the mesh debris from her body.” Similarly, Marian Goldberg has suffered permanent pain, nerve damage and incontinence worse than the original condition the vaginal mesh was intended to treat. Given that the vaginal mesh implants were “approved without being tested on its own merits. That in itself is unconscionable . . . Then to have been allowed to stay on the market when it was modeled on a device that was already impaired is unbelievable.” In spite of increased media attention, FDA advisory meetings and FDA warnings, vaginal mesh implants remain on the market.
Vaginal Mesh Lawsuits
If you or a loved experienced vaginal mesh complications after receiving treatment to repair pelvic organ prolapse, you may be able to file a vaginal mesh lawsuit seeking compensation for your medical expenses, pain and suffering, lost wages and more.
Contact a vaginal mesh lawyer at our firm today for a free and confidential lawsuit evaluation. The vaginal mesh lawyers at Bernstein Liebhard LLP have extensive litigation experience and have recovered billions of dollars for their clients. In addition to being staunch advocates for your claim, our vaginal mesh lawyers also provide personal attention to guide you through the complex litigation process.