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 new filings follow lawsuits lodged against C.R. Bard Inc. (NYSE:BCR) for its Avaulta transvaginal mesh, filed earlier this month, ClassAction.org reported.
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.
FDA breast implant safety panel this week
The FDA is holding its General and Plastic Surgery Devices Panel this week and plans to focus on tracking the safety and efficacy of silicone breast implants, Medpage Today reported.
The Motley Fool makes the case for Medtronic
Medtronic’s earnings aren’t as important as its free cash flow, which has a higher revenue margin than St. Jude Medical Inc. (NYSE:STJ), Stryker Corp. (NYSE:SYK) or Boston Scientific Corp. (NYSE:BSX), the Motley Fool reported.
Don’t consider cost in weighing treatment, American Medical Assn. says
The American Medical Assn. is circulating a comment letter asking that government-funded research conducted under the Patient Centered Outcomes Research Institute exclude cost in order to ensure there is no rationing down the line, Healthwatch reported.
A new surgical robot to challenge the throne
The Amadeus robot-assisted surgery system, under development by Titan Medical Inc., may take a bite of Intuitive Surgical Inc.’s (NSDQ:ISRG) Da Vinci system, which has the corner on the market, the Pipeline reported.
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