MAYFIELD HEIGHTS, Ohio, Jan. 10, 2012 /PRNewswire/ -- Transvaginal mesh will undergo new safety studies, as required by the FDA. The product defect lawyers at Elk & Elk are currently investigating transvaginal mesh claims.
The Food and Drug Administration is requiring more than 30 transvaginal surgical mesh manufacturers, including Johnson & Johnson, Boston Scientific Corp. and C.R. Bard Inc., to perform post-market safety studies after a fivefold increase in the number of complications linked to these devices.
The manufacturers will study side effects of the devices, including mesh erosion, pain and infection. They must provide data on the effectiveness of transvaginal mesh implants for treating conditions like pelvic organ prolapse and stress urinary incontinence in women.
Approximately 300,000 women underwent transvaginal mesh procedures in 2010, according to the FDA, and many manufacturers are now facing lawsuits for complications involving transvaginal mesh. The Ohio injury lawyers at Elk & Elk are investigating claims for transvaginal surgical mesh injuries.
In July 2011, the FDA issued a safety communication alerting patients of the risks of transvaginal surgical mesh. The alert came after transvaginal mesh was linked to a much higher rate of complications than claimed by manufacturers.
"Now these companies are going to have to tell the truth," said Lana Keeton in an article in Bloomberg Businessweek. Keeton is a mesh recipient and patient advocate from Austin, Texas. "Up until now, there's been no data. It's all been marketing."
Transvaginal surgical mesh hasn't been adequately tested as a safe and effective treatment for POP or SUI. Elk & Elk's product defect lawyers support the FDA's decision for additional testing of transvaginal mesh devices.
If you or a loved one underwent a transvaginal mesh surgery to treat POP or SUI and are experiencing painful complications, get in touch with the Ohio injury lawyers at Elk & Elk to make sure you're fairly compensated for your injuries. Call 1-800-ELK-OHIO for a free, no-obligation case consultation.
About Elk & Elk:
Elk & Elk is one of Ohio's premier personal injury and medical malpractice law firms. It represents individuals and families in serious personal injury and wrongful death cases throughout Ohio and around the country. Its lawyers are renowned for their achievements in the courtroom and their contributions in the community. The experience and resources of the firm has resulted in exceptional results for its clients.
Contact Jay Kelley at 1-877-355-1355 x 1154 or firstname.lastname@example.org.
|SOURCE Elk & Elk|
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