It is possible for the pelvic organs in a woman’s body to slip out of place. This condition, known as pelvic organ prolapse1, occurs when the muscles and ligaments supporting the pelvic region become weaker. Different treatment options are available, depending on the nature of the prolapse. One of these treatment options is pelvic mesh.
How pelvic mesh works
A doctor may use pelvic mesh to reinforce tissue that is failing to support the bladder, uterus or bowel so that they no longer bulge out of place. A doctor will decide whether pelvic mesh is suitable based on the nature of the problem and the patient’s medical history. Mesh placement is a surgical procedure and only an experienced professional should undertake the operation.
Risks of pelvic mesh
Success rates with pelvic mesh differ according to a number of factors, and there are risks2 that may accompany its use. These can include heavy bleeding, post-surgery infections or chronic vaginal pain. Other more serious side effects are also possible. Mesh erosion or extrusion can occur when the mesh edges cut through the vaginal lining and other nearby organs.
These complications can be very painful and cause serious disruption to a patient’s life. Furthermore, they may require additional surgery in order to correct the problem.
Regulation in the United States
The U.S. Food and Drug Administration (FDA) approves the use of all medical devices on the market, including pelvic mesh. The agency may issue a recall on a medical device for safety reasons, or a manufacturer may recall the device voluntarily.
In October 2008, the FDA published a Public Health Notification3 advising consumers and health care professionals about the risks of using pelvic mesh. The FDA advised that they had received more than 1,000 reports from nine different manufacturers related to surgical mesh products. An update4 was issued in 2011, stating that the potential complications of using surgical mesh were more likely than previously reported.
Common pelvic mesh brands
Many women in the United States who have been injured by the use of pelvic mesh brands have filed lawsuits against the manufacturers. Pelvic mesh manufacturers and brands include:
- American Medical Systems, Inc. — Elevate®, Perigee® and Apogee®
- Boston Scientific — Pinnacle Posterior Pelvic Floor Repair Kit®, Polyform Synthetic Mesh® and Prefyx PPS System®
- C. R. Bard, Inc — Avaulta®, Pelvisoft BioMesh®, Pelivicol Acellular Collagen Matrix® and Pelvitext®
- Johnson & Johnson (J&J pelvic mesh) — Gynecare®, Gynemesh®, Gynecare Prolift® and Gynecare TVT®
The FDA has issued a recall for some of these brands. In other cases, consumers are asking for a recall (for example an Avaulta mesh recall). If you believe you have been injured by any of these brands or others, you should contact an attorney for advice. You may be entitled to compensation.