Surge In Vaginal Mesh Lawsuits Indicative Of Flawed FDA Approval Process
Bernstein Liebhard LLP reports on an October 20, 2011 Bloomberg News article, which chronicled how Johnson & Johnson’s vaginal mesh implants received market approval from the U.S. Food and Drug Administration (“FDA”) by claiming it was “substantially similar” to a now-recalled vaginal mesh product made by a different medical device manufacturer.* Bloomberg News highlighted the flaws in the expedited FDA 510(K) process, focusing on how the defective vaginal mesh implants have caused serious and life-threatening injuries to women who received them. Currently, there are more than 600 vaginal mesh lawsuits pending against Johnson & Johnson and other manufacturers. Moreover, the FDA estimates that almost 300,000 women received vaginal mesh implants in 2010. Therefore, the number of vaginal mesh lawsuits is likely to grow.
Closely Scrutinizing The FDA 510(K) Approval Process
In the report, Bloomberg News traced the history of vaginal mesh implants that are currently available on the market. Using the expedited FDA 510(K) process, Johnson & Johnson received clearance for their vaginal mesh implants based on their similarity to Boston Scientific Corporation’s ProteGen vaginal mesh implants, which had previously received FDA market approval. Vaginal mesh implants are used to treat urinary incontinence, or pelvic organ prolapse, a condition in which the internal organs slump into the vagina. Complications from vaginal mesh implants can cause discomfort, painful intercourse, scarring and erosion of vaginal tissue. Due to the serious nature of these complications, ProteGen vaginal mesh implants were subsequently recalled and pulled from the market after the manufacturer received numerous safety complaints. However, all other vaginal mesh products produced by other manufacturers were allowed to remain on the market. In fact, the FDA continued to approve vaginal mesh implants through the fast-track 510(K) process even after the ProteGen recall. Recently, the FDA’s approval process has been the subject of increased media attention, which prompted the agency to hold advisory meetings and issue warnings.** However, vaginal mesh implants have not been recalled, nor has the 510(K) process been reformed.
FDA Recommends Patients Should Consider Alternatives To Vaginal Mesh
On July 13, 2011, the U.S. Food and Drug Administration (“FDA”) issued a transvaginal mesh warning advising patients and doctors to consider alternative treatments to vaginal mesh. In 2008, the FDA issued its first communication regarding the dangers associated with vaginal mesh, and has since continued to review the safety of the devices. Since that time, Bernstein Liebhard LLP has provided a wealth of consumer information concerning vaginal mesh on its website, www.consumerinjurylawyers.com. If you or a loved one underwent a surgical procedure and have been implanted with vaginal mesh, you may be entitled to compensation for medical bills, pain and suffering, lost wages and other injuries.
For more information about filing a vaginal mesh lawsuit, contact an attorney at Bernstein Liebhard LLP at (877) 779-1414 or at email@example.com.
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993, including those who have been harmed by dangerous drugs, defective medical devices and consumer products. The firm has been named by The National Law Journal to the “Plaintiffs’ Hot List,” recognizing the top plaintiffs’ firms in the country for the past nine consecutive years. Only two firms in the country have been selected for the Hot List nine years in a row.
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