FDA Orders Transvaginal Mesh Manufacturers to Conduct More Safety Tests to Study Serious Risks

January 13, 2012

Vaginal mesh attorneys at Pintas & Mullins Law Firm are warning patients of a recent spike in serious injuries and death associated with the use of defective transvaginal mesh devices. In response to growing number of complications such as pain, bleeding, infection, and erosion reported by women implanted with the mesh sling, federal regulators recently ordered manufacturers to conduct new medical studies to evaluate the safety and effectiveness of these devices.

On January 3, 2012, the U.S. Food and Drug Administration mandated additional postmarket studies from more than 30 transvaginal mesh manufacturers, including Johnson & Johnson, American Medical Systems (AMS) and C.S. Bard. As Bloomberg News is reporting, these mesh manufacturers must provide three years of research data to the FDA in order to determine whether the devices should remain on the market.

The vaginal mesh products were originally approved though the FDA's controversial fast-track approval process, which allows products to reach the market without clinical studies or tests. In 2010, nearly 300,000 women were implanted with a mesh sling in order to treat stress urinary incontinence and pelvic organ prolapse (POP). Unfortunately, studies show that the edges of the mesh fibers can erode through the vaginal wall, tear the body's internal organs, and cause serious pelvic pain and infections. The FDA has already received more than 1,500 reports of serious complications involving transvaginal mesh.

In July of 2011, the FDA acknowledged the serious safety risks associated with transvaginal mesh products and issued a safety alert to patients. At that time, the agency also admitted that it found no benefit in using transvaginal mesh to treat POP in place of other, safer alternatives. An advisory panel recommended that the FDA re-categorize the mesh products as "high-risk" but the agency has yet to act on that recommendation.

Vaginal mesh erosion is one of the most serious side effects that many women have suffered, and requires removal of the vaginal mesh. Other serious and painful complications include bladder perforation, vaginal scarring and recurrent organ prolapse.

As more and more women experience these devastating side effects, the number of lawsuits filed in connection with defective mesh slings continues to grow. Medical device manufacturers have a duty to appropriately test their products before releasing them into the market. These manufacturers also have a duty to warn doctors and patients about serious health risks. When a defective medical device results in death or other severe health complications, the manufacturer can be held responsible with the help of a defective drug lawyer. A vaginal mesh lawsuit holds the device manufacturer legally and financially responsible for complications that patients experience, such as bleeding, scarring and vaginal erosion.

Our vaginal mesh lawyers are currently representing many women who underwent surgery for stress urinary incontinence or pelvic organ prolapse and suffered harm. If you or a loved one suffered from vaginal mesh complications, you may be entitled to compensation your medical bills and pain and suffering. It is important to contact an experienced mesh lawyer today in order to protect your legal rights. Given that the FDA has not yet issued a recall for these defective devices, they continue to remain on the market, exposing patients to potential harm.