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FDA Warning: Transvaginal Surgical Mesh May Cause Serious Complications
| On October 20, 2008, the Food and Drug Administration (FDA) issued a Public Health Notification warning consumers and health practitioners about serious complications associated with transvaginal placement of surgical mesh used to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). |
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Injured By Transvaginal Surgical Mesh Complications? Contact Consumer Injury Lawyers Today for a Confidential and Free Case Evaluation Tool Free: (877) 779-1414
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The FDA stated that, over the last three years, it has received more than 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. Typically, these surgical mesh devices are placed transvaginally (through the vaginal wall) using a minimally-invasive procedure.
The transvaginal surgical mesh complications most frequently reported to the FDA included:
- erosion through vaginal epithelium
- infection
- pain
- urinary problems
- recurrence of prolapse and/or incontinence
Additionally, the FDA received reports of bowel, bladder, and blood vessel perforation which occurred during insertion of the transvaginal surgical mesh. In some cases, discomfort and pain (including dyspareunia) from vaginal scarring and surgical mesh erosion led to a significant decrease in patient quality of life.
The FDA has not yet determined whether specific characteristics put some patients at an increased risk for transvaginal surgical mesh complications. Contributing factors may include the patient’s overall health, the transvaginal surgical mesh material, the size and shape of the surgical mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status.
Treatment of the various types of complications associated with transvaginal placement of surgical mesh may require additional surgical procedures (some of them to remove the transvaginal mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.
In order to help the FDA learn more about possible problems with transvaginal placement of surgical mesh, physicians and patients are strongly encouraged to report complications that may be associated with this medical device. Complications related to transvaginal surgical mesh can be reported to the FDA’s MedWatch Adverse Event Reporting Program at www.fda.gov/MedWatch/report.htm.
Transvaginal Surgical Mesh Complications Attorney
If you or a loved one has experienced the painful complications associated with transvaginal placement of surgical mesh, including Avaulta surgical mesh, you may be entitled to compensation for your injuries. Contact our surgical mesh lawyers today for a confidential and free case evaluation. We are in favor of a Avaulta surgical mesh recall.
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About Bernstein Liebhard: BL is a nationally recognized law firm located in New York City that exclusively represents injured plaintiffs in a variety of individual and class actions. We have been ranked among the top plaintiffs law firms in the country by the National Law Journal for the past six years--an honor achieved by only one other law firm in the United States. Our experienced Transvaginal Surgical Mesh trial attorneys are standing by ready to review your case. We represent our injured clients on a contingency fee basis, meaning that we advance all costs and do not collect any attorneys fees unless we are successful. |
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