Pelvic Organ Prolapse (POP) is a medical condition suffered by women where a woman’s pelvic organs fall from their normal position and protrude into a patient’s vagina. While the condition can occur to any woman, women who have had very long labors or large babies are more prone to the condition. Women who smoke, are obese or have strain injuries are also at increased risk to experience pelvic organ prolapse.
POP was often the cause of a hysterectomy — removal of the uterus — in women. Surgeons also have other surgical options which include repairs to the vaginal wall through a transvaginal procedure.
Surgeons have increasingly been using surgical mesh, implanted through the vagina, to repair the prolapse. Surgeons had an option of using a non-absorbable synthetic, an absorbable synthetic or a biolgic to do the repair. However, in most cases, surgeons used a non-absorbable synthetic polyproplene.
The FDA reports that 300,000 women underwent POP repair in 2010 alone and in 75,000 of those cases, surgeons opted for the mesh repair.
Now it has come to light that some women who have had a repair with non-absorbable surgical mesh have suffered some serious and some time debilitating complications.
On July 13, the U.S. Food and Drug Administration issued a notice that with who had the transvaginal mesh repair have a five fold increase of pain and injuries. Last week Public Citizen, a consumer advocacy group petitioned the FDA to have the medical devices pulled off the market.
Up to 600 women with serious injuries have filed lawsuits against some of the leading manufacturers of the surgical mesh including Johnson & Johnson. The lawsuits claim that the manufacturers were negligent in bringing the product to market and did not do due diligence in testing what they say is a defective product. So far, none of the lawsuits have gone to trial.
The Farber Law Group is closely monitoring news feeds from the FDA and keeping abreast of the latest developments. We are a personal injury law firm and we represent people who have been seriously injured by dangerous or defective products .
Congress and FDA discussing medical device review process
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