MASSDEVICE ON CALL — Boston Scientific Corp. (NYSE:BSX) and American Medical Systems Holdings Inc. (NSDQ:AMMD) found themselves at the center of a lawsuit claiming that transvaginal mesh products sold by the companies were defective and caused severe injuries to a patient.
The complaint cited mesh complications leading to body tissue erosion, a propensity to harbor infection and a tendency to migrate from the original implant site.
The FDA recently issued warnings associated with the products, which are used reinforce and support organs that prolapse into the vagina when internal support structures weaken.
"There are clear risks associated with the transvaginal placement of mesh to treat POP," said Dr. William Maisel, deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health, in an agency release last month. "The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh."
Consumer watchdog group Public Citizen filed a petition with the FDA earlier this month asking the agency to issue a recall for all transvaginal mesh products.
An FDA advisory panel is scheduled to hold a two-day meeting on Sept. 8 and 9 to develop recommendations for the use of transvaginal mesh.
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