FDA continuing to review vaginal mesh implants

Monday, July 18, 2011

According to a Los Angeles Times report this month, the U.S. Food and Drug Administration has released an updated warning focused on surgical mesh that is implanted into women to help strengthen their vaginal tissue.

The FDA was quoted as saying that they have conducted a review of literature and reports that show little evidence that the vaginal mesh implants help pelvic organ prolapse. Not only did the reviews find little advantage to using the mesh implants, but they also found numerous risks.

The report states that in September the FDA held an expert panel meeting to discuss the future of the product. Right now, it’s estimated that around 75,000 women who used vaginal mesh were treated for pelvic organ prolapse.

Warnings began to pop up concerning the vaginal mesh in 2008, mainly because of numerous reports which began to arise after 2005. According to the Times article, the FDA warned doctors to get special training in the placement of mesh. Since the 2007 FDA warning, there’s been an influx in complaints relating to prolapse repair.

According to the article, medical devices are often cleared without the requirement of clinical trial data. With these limited restrictions, a number of different products which are considered similar to other ones can be approved for selling.

The FDA is set to continue overseeing these vaginal mesh implants in all forms, to see if they may run the same level of risk. The agency has been under criticism for a few years due to the approval process for medical devices.

The report states that any future banning on the vaginal mesh products are highly unlikely, even if they required approval applications. FDA representatives have been quoted as saying that removing the products right now wouldn’t be appropriate. The agency is said to be planning on continuing spreading information to health care providers and patients concerning the possible risks associated with the products.

Mai Duc, Christine. (July 13, 2011). “FDA reevaluating vaginal mesh implants.” Retrieved on July 18, 2011 from the Los Angeles Times.