One of the manufacturers of the transvaginal mesh device, American Medical Systems, has announced that a settlement has been reached with lawyers representing about 22,000 patients injured by its use. The settlement is for $830 million, which will work out to about $40,000 for each patient, before paying their legal fees.
Transvaginal mesh (TVM) is a polypropylene mesh used to treat pelvic organ prolapse or urinary incontinence. The device is permanently implanted to reinforce the weakened vaginal wall for pelvic organ prolapse repair or supports the urethra or bladder neck for the repair of urinary incontinence.
Surgical mesh is intended to provide additional support when repairing weakened or damaged tissues. In the TVM cases, the meshes support pelvic organs that have slid forward and downwards, relieving the pressure on the uterus and bladder that causes prolapse or urinary incontinence.
The US Food and Drug Administration (FDA) apparently approved the product without requiring the manufacturers to show any patient data on its safety.
The problem with the TVM is that it broke down over time, causing infection. Some women were able to have the device surgically removed, but in other cases, doctors were unable to remove the TVM, even after multiple surgeries, usually because the mesh had eroded into the vaginal wall.
The serious side effects that patients have experienced have included:
- Infection and bleeding
- Perforation of the bowel and bladder
- Pain and discomfort during sex
- Pain and discomfort during urination
The settlement agreement is intended to resolve “a substantial majority” of the TVM claims American Medical Systems Inc. (AMS) and its parent company, Endo International PLC.
Plaintiffs have alleged that the AMS product is defective. Plaintiffs also allege that doctors and patients were not properly warned about possible complications with its use.
The Wall Street Journal included a quote from the manufacturer, stating: “The agreements are not an admission of liability or fault, Endo said, adding individual plaintiffs’ law firms must fulfill certain requirements to receive a portion of the settlement, including verification of an implant and other pertinent medical records.”
Endo is one of seven companies facing litigation over its transvaginal mesh products.
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