FDA Called to Ban Surgical Mesh Implants

Public Citizen, a public advocacy group, recently petitioned the United States Food and Drug Administration to recall all non-absorbable synthetic surgical mesh products used in treating pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Public Citizen said that vaginal mesh should be recalled because it does not offer significant benefits but rather, exposes patients to risks and serious complications. Public Citizen was joined by a professor of obstetrics and gynecology at Washington University in St. Louis and a urologic surgeon specializing in female urology, including POP, at the Mayo Clinic in Rochester, Minn.

A POP occurs when the pelvic organs descend, or "prolapse" into the vagina or the vaginal opening. Although it most commonly affects the bladder, it can also occur when the uterus or small bowel drop into the vagina. The main reason this occurs is because the muscles and ligaments that surround the pelvic organs and keep them in place become weakened or stretched during childbirth or after a hysterectomy, or surgical removal of the uterus.

Although many women do not experience symptoms of a pelvic organ prolapse, those that do report extreme discomfort, pressure, difficulty going to the bathroom, and pain during sexual intercourse. There are non-surgical options available including performing Kegel exercises to strengthen the pelvic floor muscles and Botox to treat incontinence. However, surgery is the most common treatment option to alleviate the discomfort of a POP.

Surgical methods involve implanting a non-absorbable mesh transvaginally, or through incisions and punctures made through the wall of the vagina, with the intent of reinforcing the tissue around the pelvic organ that has prolapsed and to prevent any future prolapse.

The FDA estimates that in 2010, more than 100,000 women were treated with POP with a surgical mesh. Of those, 75,000 women had a mesh transvaginally implanted. According to Public Citizen, approximately 67,500 of these procedures used non-absorbable mesh. Public Citizen said in the petition that this device offers no clinical significant benefits and has high risks of serious complications, which may or may not be fixed through additional surgeries.

In a report released in July 2011, the FDA cited more than 1,000 manufacturer complaints and said that the device has some serious complications. One of the most common and consistently reported complications is mesh erosion where the device erodes into surrounding tissues and organs and can protrude through the skin. Other common complications include mesh shrinkage, mesh migration, painful sexual intercourse, painful urination, bleeding and an increased risk of infection.

Public Citizen calls on the FDA to ban the marketing of all currently available non-absorbable mesh products that are designed and specifically labeled for transvaginal mesh repair of POP, to order manufacturers to recall their products, and to require that any future products be classified as a class III medical device and be subject to more stringent approval requirements.

"Surgical mesh in POP treatment procedures needlessly exposes patients to a wide array of serious risks, many of which can permanently alter women's quality of life," said Dr. Michael Carome, deputy director of Public Citizen's Health Research Group. "Even the FDA seriously questions the safety and effectiveness of these mesh products, so they should be removed from the market immediately."

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