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Transvaginal Mesh Warnings Added to Labels

One transvaginal mesh manufacturer is adding new safety labels to its pelvic meshes and slings, saying the devices are considered permanent implants and it can be complicated or impossible to remove them.

Transvaginal mesh products have been used for around 15 years, mostly to treat pelvic organ prolapse (POP) and stress urinary incontinence problems in females. Since that time, 27 clinical studies have shown that one in 12 patients have suffered some form of TVM complication. It has been estimated that 50 percent of women by the age of 50 years will have some degree of POP and more than 10 percent by the age of 80 will require surgery.

The warning came from Boston Scientific, which involves five different brands of TVM slings, and was sent by way of an urgent advisory letter to doctors worldwide in May. A Minneapolis newspaper reported that a company spokesman said changes were prompted by a review of data by company officials and medical device regulators in Australia.

The FDA warned doctors twice. The first warning was sent in 2008, and inspite of the warning, the use of mesh for POP actually increased. Of course this begs the question: do doctors heed the FDA warnings? Again in 2011, the FDA sent out a stronger warning regarding mesh to treat POP: “There were an enormous number of serious, unique complications with use of vaginal mesh and that these cases were just the tip of a looming iceberg.”

Between 2008 and 1014, Johnson & Johnson alone sold 787,322 of its Ethicon TVM devices in the United States. Around 42,000 were sold in California, resulting in its latest lawsuit: California Attorney General Kamala D. Harris announced that her office is suing J&J for alleged false advertising and deceptive marketing of it transvaginal mesh products.

American Medical Systems (AMS) is currently facing about 46,000 lawsuits. AMS was the first transvaginal mesh manufacturer to resolve its product liability cases and closed its unit that sells the devices.

Boston Scientific is facing more than 36,000 product liability cases. And it remains to be seen whether physicians pay attention to a manufacturer. Many women have lost trust in their doctors. Some are frustrated and some blame their surgeons for mesh complications. A number of women have reported that their doctors said the mesh was the best thing since sliced bread and their problems “are all in your head.” Their surgeons never discussed the procedure in detail, or if there were any mesh complications.