- Transvaginal Mesh: "A Female Surgical Nightmare"
- October 10, 2012
- Law Firm: Lieff Cabraser Heimann Bernstein LLP - San Francisco Office
Earlier this year, Lindsay Beyerstein, award-winning investigative journalist of In These Times, examined the medical controversy surrounding transvaginal mesh implants in “A Female Surgical Nightmare.”
Transvaginal mesh was marketed by medical manufacturers as a product that could surpass old treatment methods for pelvic organ prolapse (POP) in terms of efficacy and affordability. However, many patients have experienced symptoms including mesh erosion, urinary problems, such as incontinence, infection, pain, and vaginal scarring.
Watchdog groups, injured patients and concerned physicians have expressed frustration at the FDA’s 510(k) premarket approval process and post-market surveillance process.
The FDA has taken steps to monitor the mesh. In 2011, the FDA issued a warning, stating that complications due to mesh are not rare and can be serious. By September 2011, the FDA held a public meeting to hear opinions about mesh regulation.
In early 2012, the FDA ordered mesh manufacturers to test the safety and efficacy of their products and report back. If the mesh products do not pass the test, they must be taken off the market. Currently, the FDA is considering reclassifying mesh products to a high-risk, Class III product. If reclassified, all mesh products will have to apply for premarket approval.