MESH NEWS DESK, September 26, 2016 ~ This story originally ran last March but is is appropriate as the organization, the American Urogynecologic Society (AUGS) begins its annual conference this week in Denver.
Expect to see some discussion of litigation and what potential exposure implanting physicians might expect from the plaintiffs who have so far filed more than 100,000 product liability lawsuits against seven manufacturers.
Though there are divisions among the 1,900 members of AUGS about the use of polypropylene slings and tape for POP, as an organization its position papers still supports the use of mid-urethral slings (MUS).
Introduced in the late 90’s, for the next decade, about seven manufacturers were in competition to get their polypropylene (PP) mesh implants to the market. One, Prolift by J&J, even bypassed any Food and Drug Administration (FDA) approval 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.”
The FDA, noting a five-fold upswing in complications, ordered post-approval studies to determine how implanted women were faring.
This year, the FDA gave industry 30 months to reclassify mesh for pelvic organ prolapse (POP) to class III or high risk. Manufacturers, facing the challenge and expense of conducting clinical trials, have instead taken their POP mesh off the market- Ethicon removed Prolift, Boston Scientific removed Pinnacle.
Boston Scientific is fighting allegations it imported counterfeit mesh resin from China when its U.S. supplier cut off the company, and American Medical Systems, sold to Endo, decided in February to close its women’s health division that makes mesh – ASTORA Women’s Health – due to the cost of litigation.
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.
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 manufacturers, 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 can support a program at the platinum level for $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 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 from corporations. #
AUGS Talking Points – Physician talking points
AUGS Informed Consent – AUGS Mesh Toolkit – Prepared Responses to FDA questions formatted
FDA Considers Reclassifying Surgical Pelvic Mesh Instruments