AUGS advocates for evidence-based options that enhance the choices available to members and their patients who suffer with pelvic floor disorders.
Many of you will have seen the “60 Minutes” segment investigating issues with synthetic mesh implants which they called “gynecologic mesh.” This broadcast focused primarily on a single manufacturer, and issues around the supply chain and manufacturing process. It did not distinguish between mesh for SUI and mesh for prolapse. We are concerned that the broadcast could lead many patients to believe that implants they have received are inherently defective as a result of the manufacturer, and are more likely to either dissolve and disappear or, conversely, to create permanent complications.
AUGS cannot comment on the manufacturing and regulatory decisions or processes of any manufacturer. However, AUGS has no reason to disagree with the FDA’s conclusions based on a more robust interpretation of data, that currently available mesh poses no new safety concerns. On May 15, 2018 the Boston Globe provided the following statement from FDA officials:
“The FDA takes its commitment and obligations to patient safety very seriously. After the FDA became aware that Boston Scientific changed suppliers for the polypropylene resin used in the gynecologic mesh products, we conducted an extensive investigation. The FDA conducted its own testing of the finished product for specific mechanical properties and physical characteristics and determined that all samples met the appropriate specifications. We also evaluated information [data and analysis], from various sources available to the FDA including the company, regarding the polypropylene raw material, as well as the finished mesh manufactured with polypropylene resin from both sources, and we conducted inspections of Boston Scientific and two of its contract manufacturers. Further, we reviewed our adverse event reporting database and did not find any indication that the change in resin led to an increase in adverse events. As a result, the FDA concluded that the new resin does not raise new safety or effectiveness concerns. In December of last year, we asked 60 Minutes for the opportunity to review their test results and hoped they would have provided this information as soon as possible, especially if they believed this data could impact public health. They declined until after their report aired, and we still have not received this information. While we have confidence in our investigation findings, we welcome any new information that would help us better evaluate this product and protect the health of patients.”
AUGS has not changed our positions about midurethral slings or mesh-based options for patients with pelvic floor disorders, nor our support for the availability of non-mesh alternatives. [Position Statement: Mesh Midurethral Slings for Stress Urinary Incontinence] We also recommend that patients who are without signs or symptoms of mesh-related complications should not be advised to undergo surgical procedures to remove their implants. We remain concerned about the practice of surgeons accepting payment from lawyers’ offices or third-party financiers to perform mesh removal surgeries which may not be clinically indicated but are being used to bolster a legal claim.
These are highly-charged issues, and passions run high. Optimizing the care of our patients demands that we remain objective, and rely on science in assessing the role of treatment modalities.