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FDA Issues Public Health Notification for Transvaginal Surgical Mesh



Over 1,000 Reports of Complications in 3 Years

FDA has issued a public health notification concerning serious complications associated with transvaginal placement of surgical mesh used in the repair of pelvic organ prolapse (POP) and urinary Stress Urinary Incontinence.

Over the past 3 years, FDA has received more than 1,000 reports from 9 surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. These mesh devices are usually placed transvaginally utilizing tools for minimally invasive placement.

The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.

Treatment of the various types of complications included additional surgical procedures (some of them to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.

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Published on Oct-21-08

LEGAL ARTICLES AND INTERVIEWS

Inside the $13 Million Pelvic Mesh Award: A Defendant Without Empathy
Inside the $13 Million Pelvic Mesh Award: A Defendant Without Empathy
January 18, 2017
Philadelphia, PA: Following the refusal of a Pennsylvania state judge to strike down a $13.7 million transvaginal mesh lawsuit verdict, defendant Johnson & Johnson and its Ethicon unit immediately signaled they would appeal the award to the state Supreme Court, in spite of the judge’s admonitions that the plaintiff’s suffering was real and chronic. READ MORE

Transvaginal Mesh Problems in Canada
Transvaginal Mesh Problems in Canada
November 4, 2016
Toronto, Ontario Exactly how many women in Canada have had transvaginal mesh implanted to deal with bladder issues or collapsing pelvic organs is not known. Estimates run as high as 60,000 women. What is clear is that there are hundreds of Canadian women who are so unsatisfied with the results that they have filed transvaginal mesh lawsuits– many of those women have had surgery to remove the mesh. READ MORE

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