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One Product Different Results – Transvaginal Mesh Disputes.

Although it sounds unsightly, it is true. Pelvic Organ Prolapse (POP) is a medical condition that occurs when your organ drops out of place in your belly and exerts pressure against the vagina. Some of the organs involved in case of prolapse include are bladder, urethra, uterus, vagina, small bowel, and rectum. It is more common in older women and can occur as result of weakened pelvic muscles due to childbirth, hysterectomy, and menopause.

Doctors now have a technique whereby a transvaginal mesh (TVM) implant is inserted through the vagina to permanently fix POP. While inserting a the mesh through the abdomen is possible, placement of the mesh through the vagina is easier and less invasive.

It does however have its own risks including the product (mesh) being defective, or faulty manufacture recommended surgical technique. The results of surgery gone wrong include serious infection and injury and scarring to vaginal tissue and nearby organs.

Where does the law stand on the issue?

The Food and Drug Administration is critical safeguard to ensure medical products on the market are safe. While safety is a primary concern, it is not always guaranteed. Advocacy groups of exerted pressure on the FDA for a total ban of transvaginal mesh. Transvaginal mesh, however, is still on the market and being used to help with women experience POP. The FDA provided some reassurance however, and reclassified transvaginal mesh from a Class II to a Class III product. (According to the FDA, a class III device generally requires premarket approval.)

Legal Outcomes

Pharmaceutical companies across the nation are being hailed into court to defend their product. Their outcomes vary drastically. Take for example a Massachusetts case against Boston Scientific Corporation. In the second trial the jury sided with Boston Scientific with a verdict that Obtryx was not defectively manufactured, and adequate risk warnings were provided to doctors and patients. But companies are not all made equally, and neither are the products they manufacture nor the juries they encounter. In a Dallas, Texas case, Boston scientific was not so lucky. A 42-year-old plaintiff was awarded $23 million dollars after a when a jury found Boston Scientific was grossly negligent. The plaintiff successfully persuaded the jury Boston Scientific knew of the Obtryx’s questionable safety, and yet failed to warn doctors and patients.

Boston Scientific is not the only company facing suits for similar claims. Other manufacturers include Johnson & Johnson, C.R. Bard Inc., and Endo International. While Johnson and Johnson, were each ordered to pay more than $13 million dollars, Endo International agreed to pay $830 million to settle nearly 20,000 transvaginal mesh suits.