AdvaMed Reveals New Information In Light Of Transvaginal Mesh Meeting

As recent as July 2011, the U.S. Food and Drug Administration (FDA) issued an updated safety communication regarding the safety and effectiveness of transvaginal mesh products. The safety communication was the result of an influx of adverse transvaginal mesh reports that had escalated in recent years. Due to the severity and frequency in which these reports have been received, an advisory committee to the FDA has scheduled a meeting later this week to discuss potential changes in regulation, if any are required. The meeting will likely have overwhelming repercussions in the transvaginal mesh industry. Therefore, a number of manufacturers have submitted data in an attempt to convince the FDA that transvaginal mesh benefits outweigh the risks.

The Advanced Medical Technology Association (AdvaMed), in collaboration with a number of world renown industry leaders, have founded the Transvaginal Mesh Industry Working Group (Working Group). Comprised of Ethicon Inc., C.R. Bard, Boston Scientific, and American Medical Systems, the Working Group represents the combined opinions of leaders in the medical device industry. The Working Group believes that the use of surgical mesh in transvaginal procedures for the treatment of pelvic organ prolapse (POP) is safe and effective. Subsequently, they believe that serious adverse events remain rare, while the surgical application of transvaginal mesh remains a valuable treatment option for women.

Of significant concern to the Working Group is this weeks deliberation of future restrictions on transvaginal mesh devices that will include stricter regulations and a possible medical device reclassification. Each of which have the potential to impact the transvaginal mesh industry in a profound way.

In a recent Docket Submission, the Working Group acknowledges that:

  • The class II, 510(k) requirements are appropriate for surgical mesh devices intended for POP treatment.
  • Special controls can be implemented to ensure the adequacy and reliability of labeling information provided to both patients and physicians, and also to ensure consistency in the evaluation of the safety and effectiveness of new products through standardized requirements, including performance of pre-market clinical trials.
  • The industry will work with Societies to develop and support training programs to ensure that physicians have appropriate knowledge of the use of transvaginal mesh devices.

Information provided by the Working Group demonstrates that the surgical application of transvaginal mesh is safe and effective in the treatment of POP. Perhaps more significantly, the Working Group feels strongly that transvaginal mesh devices should remain as a Class II medical device. Leading them to these conclusions is information provided by their own research. Initial reviews of medical device reports indicate that transvaginal mesh products coincide with long-term durable repairs and provide clinical benefits.

However, a strong argument acknowledged by the Working Group is the probability of a patient experiencing the benefits. In view of the aging population, as well as the obesity epidemic, a durable transvaginal mesh repair will become an increasingly important treatment option. In certain sub-populations, the benefit will be more pronounced as already demonstrated in the repair of anterior vaginal wall prolapse and patients undergoing secondary prolapse repairs.

In addition to their argument for the surgical application of transvaginal mesh, the Working Group acknowledges that mesh-specific adverse events are well characterized and relatively easy to treat.

The Working Group is a strong advocate in transvaginal mesh products retaining their current Class II medical device classification, subject to the 510(k) requirements. Reasoning behind their stance is due to the safety and effectiveness that has already been established through bench testing, cadaveric modeling and animal testing that has been confirmed in scientific literature and observational trials. Due to the current regulatory scheme for medical devices, this data reflects that of class II specifications.

Because regulatory controls were established before transvaginal mesh was specifically designed to treat POP, the Working Group is recommending that a new special controls document be developed to clearly define the appropriate information for continuing to
assess the safety and effectiveness of transvaginally placed mesh products used to treat POP. The Working Group acknowledges that updated controls can ensure the adequacy and reliability of labeling information provided to patients and physicians. Furthermore, newer controls will allow consistency in the evaluation of the safety and effectiveness of new products through standardized requirements, including
performance of pre-and post- market clinical trials.

New controls will include pre-market clinical data, post-market clinical data, product labeling and patient labeling. The most significant control proposed by the Working Group will be reflected in product labeling. They suggest that the Labeling of new products will contain a summary of the product-specific pre-market clinical data
collected in support of product clearance. A detailed summary of risks associated with the use of mesh kits will also be included. Patient sub-populations that are at risk for adverse events associated with transvaginal mesh procedures will be identified. Lastly, adequate information will be provided to ensure proper use of the device.

Based on their analysis of adverse event information and their review of published scientific literature, the Working Group has concluded that the benefits obtained with the use of transvaginally placed surgical mesh for the treatment of POP provide an important treatment option for women. In submitting this data the the FDA, the Working Group is asking the agency to consider relevant information when deliberating on future regulations of transvaginal mesh products at this weeks meeting.

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