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1. AUGS Defends Polypropylene Mid-Urethral Mesh Slings

   Mar 7, 2016 | Mesh Medical Device News Desk

   By Jane Akre
   
   
   It’s been a rough road for polypropylene (PP) mesh manufacturers and the doctors who implant pelvic mesh.

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Online Sources

1. AUGS Defends Polypropylene Mid-Urethral Mesh Slings

   Mar 7, 2016 | Mesh Medical Device News Desk

   By Jane Akre

   It’s been a rough road for polypropylene (PP) mesh manufacturers and the doctors who implant pelvic mesh.

   Introduced in the late 90’s, for the next decade, about seven manufacturers couldn’t get their PP mesh implants to the market fast enough. Some even bypassed any Food and Drug Administration (FDA) approval (Prolift) before the agency caught on three years later.

   In 2008, the FDA issued a safety communications after receiving thousands of complaints that mesh problems were “rare” but the agency reversed itself by 2011 saying those same complications were “not rare.”

   Prolift on eBay July 2013

   Litigation began, and tens of thousands of defective product lawsuits amassed in multidistrict litigatation with about 100,000 lawsuits filed in just four years. Pelvic mesh has been found to be defectively designed in several trials, even pelvic mesh still on the market.

   The FDA, noting a five-fold upswing in complications, ordered post-approval studies to determine how implanted women were doing.  An expert panel convened and suggests the larger PP mesh implants for pelvic organ prolapse (POP) should be reclassified and finally in January of this year the FDA announced POP mesh would be considered high-risk. The FDA gave manufacturers 30 months to prove safety or efficacy or pull their implants off the market.

   Boston Scientific is fighting allegations it imported counterfeit mesh resin from China when its U.S. supplied dried up, and American Medical Systems, sold to Endo, decided just last month to close its women’s health division that makes mesh- ASTORA Women’s Health – due to the cost of litigation.

   Desara Sling by Caldera

   On February 26, 2016, the FDA convened a special panel to consider whether the trocars or stainless steel instruments used in the blind passage of implanting pelvic mesh should be considered of “moderate risk” a move up from their present category they share with band-aids and wheelchairs. Trocars are used internally in the blind procedure of implanting mesh and have caused organ perforation, bleed-outs and nerve damage. The Gastroenterology-Urology Devices Advisory Panel will give recommendations regarding the reclassification of the instrumentation.

    

   TREATMENT WORTH PROTECTING

   Considering the above, and the fact that many doctors have been sued by mesh-injured women, might give pause to a medical society and its members to reconsider how doctors fit into the mesh mess. But it’s not.

   In a statement to its members Friday, March 4, the incoming president of AUGS (American Urogynecologic Society) Douglass Hale, MD writes mid-urethral slings are a “treatment worth protecting.”

   Hale blamed unpredictable juries who have put mid-urethral slings in the “crosshairs” of our legal system.”  Dr. Hale says companies have paid out large settlements and he points to ASTORA (formerly AMS) shutting down as an example, calling it a purely business decision, he says for AMS it was “no longer worth the fight.”

   On the contrary he says, the data is overwhelmingly in favor of slings and doctors and patients should still be able to choose this option.

   “Despite what some of our own members are saying denouncing these products as unsafe, the data tells a different story that does not support this stance.”  ~ Douglass Hale, MD 

   He calls it a “misrepresentation by our legal system” that juries have not seen the realities of these cases.

   Never mind that many doctors have also been sued along with the mesh manufacturing putting a chilling effect on the use of mid-urethral slings as well as mesh for pelvic organ prolapse (POP). Never mind that there are more defective product lawsuits filed over alleged injuries from mid-urethral slings than the larger POP mesh, and never mind that juries who have listened to the evidence have decided that the mesh still on the market is defective in its design and in its instructions to doctors.

   CORPORATE SPONSORS

   In two weeks, the AUGS Board of Directors will meet to lay out a strategy.

   And still ahead, AUGS will hold is annual convention in Denver, Colorado September 27 to October 1, 2016.

   Corporate sponsors can support a program at the platinum level fo $75,000 to the copper level at $5,000. One can even have a hotel room key imprinted with a corporate sponsor as this was from the American Hernia Society a few years ago.  See the program for sponsorship here.   

   AUGS PFD Corporate research sponsorship 2014

   
   
   AUGS is collecting a patient registry of women undergoing treatment for POP to evaluate the effectiveness, quality of life and safety associated with transvaginal/ transabdominal native tissue repair, transvaginal mesh and sacrocolpopexy and a pessary.

   It is supported by ACell, ASTORA, Boston Scientific and Coloplast.  In 2014, the PFD Research Foundation received 64% of its funding by corporations. #

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