Transvaginal Mesh Falling from Favor
In July 2011, the FDA issued a warning that surgical mesh products “are associated with significant morbidity,” and that outcomes of using surgical mesh were not better than using other non-mesh surgeries to repair pelvic organ prolapse and stress urinary incontinence.
Survey Shows Surgeons Use Surgical Mesh Less, Other Surgical Mesh More but Selectively
Recently, the 33rd Annual Scientific Meeting of the American Urogynecologic Society featured a presentation on the safety and effectiveness of surgical mesh devices, led by Catherine Matthews, MD from UNC Chapel Hill. The study was conducted in November 2011.
The survey presented was created to determine whether the FDA’s warning would have any effect on surgeons’ practices. Since 2008, surgical mesh use has increased five-fold, and the FDA received a huge increase in reports of complications related to the mesh, from neuromuscular problems to vaginal scarring. There were even three deaths directly related to mesh use. The FDA noted in their warning that most cases of POP and SUI can be treated successfully without using surgical or transvaginal mesh, “thus avoiding the risk of mesh-related complications.”
The survey, issued at the 2011 meeting, showed that specialists were more likely to use surgical mesh, and were more likely to use it to solve recurring prolapse, rather than first-time vaginal prolapse. Just over half of respondents said they included more information about surgical mesh in their counseling and recommendations to patients.
The FDA Moves to Reclassify Transvaginal Mesh Because of Associated Dangers
Last month, a federal advisory panel for the FDA met to discuss transvaginal mesh, a specific type of surgical mesh used in women suffering from pelvic organ prolapse, and which has caused the most reported complications. They discussed whether or not additional testing should be required for future versions of surgical mesh devices to be approved.
The panel was formed in response to personal injury lawsuits filed regarding transvaginal mesh, and to the FDA’s proposition that mesh devices be moved to Class III, which would require additional testing before the products could be approved.
A formal vote was not tallied at the meeting, but the majority of the medical experts on the panel agreed with the FDA’s recommendation.
Currently, surgical mesh devices are eligible for the FDA’s 510(k) process, which allows products that are similar to already-approved products to be fast-tracked for approval. In the case of transvaginal mesh, however, the original product that all current mesh devices are based on was approved in 1996, then recalled by the manufacturer in 1999 due to complaints about defects. Because of the severe complications related to transvaginal mesh, the FDA has been heavily criticized recently for the 510(k) process.
However, if surgical mesh is reclassified as a Class III device, manufacturers will be required to complete clinical trials before their products are approved. This means they will be required to thoroughly test transvaginal mesh devices to prove their safety and usefulness for patients. While this would drive the cost of the devices up, it would ensure patient safety.
While doctors may be using the mesh devices more for primary abdominal repair related to prolapse, thanks to the FDA’s warning, surgeons are reconsidering using transvaginal mesh devices to repair pelvic organ prolapse and stress urinary incontinence, particularly in women. In the meantime, there are still 6 surgical mesh multidistrict litigation suits in the works, one for each major surgical mesh manufacturer. The Strom Law Firm is handling these types of cases.
The Strom Law Firm Can Help with Your Transvaginal Mesh Lawsuit
If you or a loved one have had surgical mesh implanted to repair prolapse or stress urinary incontinence, and have since suffered harmful side effects including pain, organ perforation, bleeding, and infection, you may be entitled to compensation. The personal injury attorneys at the Strom Law Firm collectively have 30 years experience with courts, and can help get you with your transvaginal mesh personal injury litigation. We also offer free, confidential consultations to discuss the facts of your case. Contact us today at (803) 252-4800. If you prefer to speak to a female attorney, we will be glad to accommodate you.