FDA requires more testing of transvaginal mesh products after safety concerns

Transvaginal mesh implants will undergo post-market safety studies after a spike in the number of complications linked to the devices. Contact the Ohio product defect lawyers at Elk & Elk if you suffered injuries from a transvaginal mesh procedure.

The U.S. Food and Drug Administration is requiring more than 30 manufacturers of transvaginal mesh devices, including Johnson & Johnson, Boston Scientific Corp. and C.R. Bard Inc., to perform post-market safety studies after an fivefold increase in the number of complications and injuries linked to these devices, including mesh erosion, pain and infection.

Surgical mesh was originally used for hernia repair procedures in the 1950s, but it was later adapted to treat two conditions affecting millions of women, known as pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

Device manufacturers are required to conduct a three-year study to look at the side effects in women who received transvaginal mesh to treat POP or SUI. They will study rates of complications and will be required to provide data on the effectiveness of transvaginal mesh compared to other procedures.

Approximately 300,000 women underwent transvaginal mesh procedures in 2010, according to the FDA. There are now more than 650 lawsuits against the makers of transvaginal surgical mesh devices, according to an article in Bloomberg Businessweek.

The Ohio injury lawyers at Elk & Elk are currently investigating claims for transvaginal surgical mesh injuries. Contact us today if you suffer from any of the following transvaginal mesh complications:

In July 2011, the FDA issued a safety warning advising patients to seek alternative treatment options for POP and SUI. The safety communication came about after agency linked transvaginal mesh to a much higher rate of serious complications than claimed by manufacturers.

The bottom line is that transvaginal surgical mesh has not been adequately tested as a safe and effective treatment for pelvic organ prolapse and stress urinary incontinence. That’s why the Ohio product defect lawyers at Elk & Elk support the FDA’s decision for additional testing.

If you suffered complications from transvaginal mesh implants, contact the Ohio injury lawyers at Elk & Elk for a free, no-obligation case consultation. Call 1-800-ELK-OHIO. Our product defect lawyers have nearly 50 years of experience representing victims who were injured by defective medical devices and we can help you get the compensation you deserve.