Issued: October 20, 2008
Transvaginal Surgical Mesh Complications Prompt FDA Public Health Notification
Over the past three years, FDA has received over 1,000 reports from nine 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.
Due to the possibility of serious medical complications, the FDA issued a Public Health Notification and notified medical practitioners of recommended guidelines and best health care practices.
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. Specific characteristics of patients at increased risk for complications have not been determined. Contributing factors may include the overall health of the patient, the mesh material, the size and shape of the mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status.
FDA recommendations to physicians included obtaining specialized training for each mesh placement technique, and that physicians should be aware of its risks. The FDA also recommended that physicians inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication and there is the potential for serious complications and an effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall.
If you or a loved one are experiencing any of the above mentioned symptoms, you should protect yourself and contact the law firm of Rappaport, Glass, Greene and Levine immediately or complete our contact form. There are several ongoing cases for defective Transvaginal Surgical Mesh products. You may potentially receive compensation for medical expenses, wages, and disability. We offer a free initial consultation.