A rosy picture is painted but not for the women, Polypropylene seems to harbor biofilm infection. Whether it is the implant, the foreign body response or the biofilm that is sparking autoimmune disease among a subset of mesh implanted women is not yet known. Who will react badly to the implant is also not known or even being studied. One researcher believes an allergic response may forecast rejection of the implant.
Pelvic floor disorders are predicted to increase substantially in the U.S. That may be why we see White Papers produced forecasting a rosy picture for new mesh implants.
One former executive of American Medical Systems, plans to relaunch a transvaginal mesh, even as litigation closes for mesh injured women implanted with the former variations. AMS went out of business, sold its women’s gynecologic line to Endo International which closed its doors to that division. The new device planned to launch is made of the same polypropylene as the former line.
Expect launches by Caldera, which claimed it was insolvent and severely underinsured, so much so it could not pay out settlements to women injured by its meshes. The average payout was $2,000. The fight with the insurance company and legal fees took most of its $35 million fund.
Your thoughts on these projections?