On April 30, 2014, Endo International plc (“Endo”), a global specialty healthcare company headquartered in Dublin, Ireland (with its U.S. headquarters located in Malvern, Pennsylvania) that develops, manufactures, markets, and distributes pharmaceutical and device products, announced that it has reached agreements in principle to pay approximately $830 million to settle about 20,000 claims related to vaginal mesh products sold by its American Medical Systems (AMS) subsidiary.
The plaintiffs’ claims include allegations that their vaginal mesh implants eroded in some of them and as a result, they became incontinent and suffered pain. Endo’s agreement to settle the claims does not include any admission of liability or fault. The vaginal mesh plaintiffs will be required to verify the implantation of an AMS vaginal mesh product and provide relevant medical documentation. The plaintiffs will receive an average of $40,000 each, to compensate them for their alleged injuries.
Endo still faces at least 5,000 additional vaginal mesh claims against its AMS subsidiary.
Surgical mesh is a medical device that is used to provide additional support when repairing weakened or damaged tissue. Mesh products are manufactured by different companies and many of the mesh products come in kits that include instruments specifically designed to aid in insertion, placement, fixation, and anchoring of mesh in the body.
Endo’s announcement came one day after the FDA announced that it has issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP), which would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and would require manufacturers to submit a premarket approval (PMA) application for the FDA to evaluate safety and effectiveness.
The FDA proposes that instruments provided in mesh kits be reviewed as part of the regulatory submission for the mesh product and that urogynecologic surgical instrumentation be reclassified from low-risk devices (class I) to moderate-risk devices (class II).
What Is POP?
Pelvic organ prolapse (POP) occurs when the tissue and muscles of the pelvic floor no longer support the pelvic organs resulting in the drop (prolapse) of the pelvic organs from their normal position. The pelvic organs include the vagina, cervix, uterus, bladder, urethra, and rectum. The bladder is the most commonly involved organ in pelvic organ prolapse. While not a life-threatening condition, women with POP often experience pelvic discomfort, disruption of their sexual, urinary, and defecatory functions, and an overall reduction in their quality of life.
POP may occur when supporting muscles and tissue of the pelvic floor become torn or stretched because of labor or childbirth or may weaken with age. Many women have some degree of POP, although not all women have symptoms. Other risk factors for POP include genetic predisposition, connective tissue disorder, obesity, and frequent constipation.
If you or a loved one may have been injured as a result of a vaginal mesh product or surgical mesh product, you should promptly seek the legal advice of a local medical malpractice lawyer in your U.S. state who may investigate your mesh claim for you and represent you in such a claim, if appropriate.
Click here to visit our website or telephone us toll-free at 800-295-3959 to be connected with vaginal mesh lawyers (surgical mesh lawyers) in your state who may assist you with your mesh claim.
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