Some Vaginal Meshes for Prolapse Coming Off the Market; FDA Expresses Safety Concerns About These Devices

June 7, 2012

Earlier this week, Johnson & Johnson stated in federal court that it would no longer sell several of its vaginal mesh products. The company is being sued by hundreds of women who claim it caused them injuries. According to reports, earlier this year the FDA said the company had sold one of the implants, the Gynecare Prolift, for three years without proper regulatory approval.

Vaginal (or transvaginal) mesh has been one surgical approach to pelvic organ prolapse – when organs like the uterus or bladder may protrude into the vagina. This often has to do with weakness of the muscles and tissues that support these organs, and can cause pain, urinary incontinence, sexual issues, and other problems for women. Treatment options include Kegel exercises or other physical therapy, various types of surgery, and other approaches.

Last July, the FDA issued a safety communication on transvaginal placement of these surgical meshes for pelvic organ prolapse (POP), explicitly stating that:

  • “serious complications associated with surgical mesh for transvaginal repair of POP are not rare;” and
  • “it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”

The complications of the mesh described in that communication are quite serious:

…the most frequent complications reported to the FDA for surgical mesh devices for POP repair include mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems. Many of these complications require additional intervention, including medical or surgical treatment and hospitalization.

Despite this information, a Johnson & Johnson spokesperson, commenting on the decision to stop selling the products, claimed, “We continue to have confidence in the safety and efficacy of these products.”

Also in 2011, the American College of Obstetricians and Gynecologists and the American Urogynecologic Society issued a joint recommendation on the procedures, stating that it should be reserved “for high-risk individuals in whom the benefit of mesh placement may justify the risk, such as individuals with recurrent prolapse.”

In January of this year, the FDA announced that it was considering changing transvaginal mesh for pelvic organ prolapse repair from a Class II to Class III device. Class III devices are those that are considered riskiest, and require specific premarket approval from the agency, supported by scientific evidence to assure that the device is safe and effective for its intended use. The FDA also ordered more than 30 manufacturers of the mesh to submit postmarket study plans to address specific safety and effectiveness concerns.

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