The FDA has released public health notifications due to serious complications associated with transvaginal placement of surgical mesh.
Transvaginal placement of surgical mesh to repair pelvic organ prolapse (“POP”) and Stress Urinary Incontinence (“SUI”) has led to rare but serious complications that have life altering consequences. Over the past several years, the Food and Drug Administration (“FDA”) received over a thousand reports from nine surgical mesh manufacturers of complications associated with surgical mesh devices used to repair POP and SUI. Mesh devices are usually placed with minimal invasive placement, but in many cases they have led to “erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence.”
Reports of bowel, bladder, and blood vessel perforation during insertion have also been released. 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.”
The FDA provided warnings to the public stating that to treat the various complications arising from mesh, additional surgical procedures were used including removing the mesh itself. The treatments included IV therapy, blood transfusions, and drainage of hematomas and abscesses. The specific characteristics of patients at increased risk for complications have not been determined.
The FDA notifications discuss six recommendations and require hospitals and other facilities to report deaths and serious injuries associated with the use of these surgical mesh devices. The recommendations directed toward physicians included informing 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; informing patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall in POP repairs; and providing patients with a written copy of the patient labeling from the surgical mesh manufacturer if available.
The FDA provided questions women should ask their surgeons before having an operation for POP or an SUI or any surgery in which mesh is used. After telling your surgeon of any past reactions to mesh materials such as polypropylene, you should ask:
(1) what are the pros and cons of using surgical mesh in my particular case and can the repair be done without using mesh?
(2) What is your experience with implanting this particular product and what have other patients experienced with the product?
(3) What is your experience dealing with complications that might occur?
(4) What can I expect to feel after surgery and for how long?
(5) What are the specific side effects I should tell you about after surgery?
(6) What if mesh does not correct the problem?
(7) Can the mesh be removed and what are the potential consequences?
(8) May I have a copy of the patient information if it comes with the product?
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