2 medical groups call for national registry of patients treated with surgical mesh

The American College of Obstetricians and Gynecologists (The College) and the American Urogynecoloc Society (AUGS)recommends that synthetic mesh placed vaginally to treat pelvic organ prolapse (POP) should only be performed on women that surgeons deem “high risk” whose benefit from the surgery outweighs the risks. This is only one of the recommendations of The College and AUGS involving this surgical procedure in wake of many women coming forward with continuing pain after the corrective surgery and other complications.

The joint committee of The College and AUGS is also calling for a development of a national registry to track the outcomes of patients who have been or will be treated with surgical mesh.

More than 350,000 women have surgery for POP every year in the United States. POP is a condition in which the muscles in the pelvis become torn or stretched and organs in the pelvis can bulge into the vagina. A leading cause of POP is childbirth but other factors such as obesity, constipation, coughing, aging and physical activity can contribute to the condition.

Surgical mesh was first introduced to repair POP in 2001 and it was cleared through the FDA 501(k) premarket notification system which is the “fast track” for a product to get FDA approval. The approval was based on the vaginal mesh being “substantially equivalent” to the surgical mesh used in hernia repair. Products introduced to the market using the 501(k) approval do not have to go through clinical trials and provide data which supports the safety of the medical devices.

Another recommendation by The College and AUGS is that surgeons be trained specifically in the procedure to place the device. Many suspect that one factor in the device failure unskilled surgeons performing the operation.

This information is provided by Washington Injury Attorney blog, a service of The Farber Law Group. We are a personal injury law firm and we represent people who have been seriously injured due to dangerous or defective products.

Related Posts:

FDA panel reclassifies surgical mesh for pelvic organ prolapse as a class III device

FDA advisory panel to look at safety of surgical mesh for pelvic organ prolapse (POP)

FDA considers revising medical device approval process

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