The FDA is requiring further testing of transvaginal mesh devices, amid safety concerns. Contact the Ohio product defect lawyers at Elk & Elk if you suffered transvaginal mesh complications.
Safety studies required for transvaginal mesh manufacturers
The U.S. Food and Drug Administration (FDA) is requiring more than 30 makers of transvaginal surgical mesh to conduct post market studies on the safety of the device. The mandate came after a fivefold increase in the number of complications linked to women who underwent transvaginal mesh procedures to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI).
Johnson & Johnson, Boston Scientific Corp and C.R. Bard are a few of the many manufacturers who will be required to conduct additional studies on the safety transvaginal mesh devices. They will study rates of organ damage, erosion, pain and infection in women who received transvaginal surgical mesh implants. They will also be required to provide data on the effectiveness of transvaginal mesh procedures for POP and SUI.
Approximately 300,000 women underwent transvaginal mesh procedures in 2010, according to the FDA, and many companies are now facing lawsuits for complications caused by transvaginal mesh. The Ohio injury lawyers at Elk & Elk are currently investigating claims for transvaginal surgical mesh injuries.
In July 2011, the FDA issued a safety warning advising patients to seek alternative treatment options for pelvic organ prolapse. The safety communication came about after agency linked transvaginal mesh to a much higher rate of serious complications than claimed by manufacturers.
“Now these companies are going to have to tell the truth,” said Lana Keeton, a mesh recipient and patient advocate from Austin, Texas. While companies say implants are safe, “up until now, there’s been no data. It’s all been marketing,” the article in Bloomberg Businessweek reads.
Transvaginal surgical mesh needs to be adequately tested as an effective treatment for women suffering from pelvic organ prolapse and stress urinary incontinence, which is why the Ohio product defect lawyers at Elk & Elk support the FDA’s decision for additional testing of transvaginal mesh devices.
If you suffered complications after a transvaginal mesh procedure, contact the Ohio injury lawyers at Elk & Elk to learn your rights and see if you’re entitled to compensation for your damages. Call 1-800-ELK-OHIO for a free, no obligation case consultation.
Around the Web:
Bloomberg Businessweek: J&J, C.R. Bard Must Study Safety of Vaginal Mesh, FDA Says
Wall Street Journal: Surgical Mesh Gets Closer Look