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Manufacturers Prepare Their Own Evidence for FDA Panel

Manufacturers Prepare Their Own Evidence for FDA Panel

September 8, 2011: As an FDA public advisory counsel meets today and tomorrow to discuss the safety and effectiveness of transvaginal mesh in pelvic organ prolapse repair, the industry is preparing arguments of its own. The Transvaginal Mesh Working Group — a group comprised of transvaginal mesh manufacturers, working in association with AdvaMed — has officially submitted their own clinical findings to the panel, which they are asking the panel to consider during deliberations. In their docket, Working Group argues that transvaginal mesh is safe and effective. Yet, Working Group does recommend implementing special controls to ensure consistency in the products.

The Transvaginal Mesh Working Group (Working Group) is comprised of Ethicon, Inc., C.R. Bard, Boston Scientific, and American Medical System. All of these companies have recently come under fire as manufacturers of transvaginal mesh. The 4 manufacturers account for about 90% of the total number of transvaginal mesh units sold.

Under the name Working Group, they teamed up with AdvaMed, a medical trade association that represents medical device manufacturers, and submitted their own evidence, which they would like the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to consider during its deliberations.

From September 8-9, a public advisory panel is convening in Maryland to discuss the risks, benefits, safety and effectiveness of transvaginal mesh repairs. In light of recent evidence linking transvaginal mesh repairs to serious and life-altering complications, including erosion and infection, the FDA panel may make recommendations to reclassify the products from Class II to Class III, which would place stricter regulations on the products.

Meanwhile, Working Group is making the argument that transvaginally-placed mesh in pelvic organ repair (POP) is a safe and effective form of treatment. It offers patients a more durable repair, Working Group argues. They also argue that reports of complications still remain rare (at a rate of 0.16% from 2008-2010 and 0.05% from 2005-2007) and the benefits of transvaginal mesh repair outweigh the risks.

Working Group suggests that transvaginal mesh repair procedures are advantageous treatment options for patients who have a high risk of recurrence. These patients may include women with severe POP, anterior vaginal wall prolapse, poor tissue quality, or women who have already experienced recurrence after a traditional non-mesh procedure.

For these patients, Working Group believes transvaginal mesh procedures are beneficial and put them at little risk.

Working Group argues that other non-mesh procedures have similar complications rates as transvaginal mesh repairs. Additionally, while Working Group acknowledges that erosion-caused exposure into the vaginal wall is the most common complication, it believes it can be successfully managed in the majority of cases, with proper surgical technique, proper mesh and smaller-sized incisions. Working Group states that erosion into other organs is rare and predetermined conditions increase a patient’s chances of exposure. These predisposed conditions include concomitant hysterectomy, patient age, surgeon experience, smoking and diabetes mellitus.

Because Working Group believes transvaginal mesh is safe, they are urging the FDA to keep the Class II classification of the devices. Yet, Working Group is recommending special controls be implemented to ensure consistency in the evaluation of the safety and effectiveness of new products.

Working Group recommends the following actions as part of the special controls:

  • New versions of the products introduced to the market should be mandated to undergo pre- and post-market clinical trials. Pre-market clinical trials would last up to 12 months and post-market clinical trials would continue monitoring patients from pre-market clinical study for 3-5 years.
  • Existing transvaginal mesh products should undergo “active surveillance,” where by 200-500 patients who have received transvaginal mesh POP procedures are followed for up to 3 years.
  • All product labeling should be updated on both new and existing transvaginal mesh products to reflect the findings of the clinical trials. The uniform product labeling would include the clinical data as it became available, as well as identification regarding patients who may be at risk of complications.
  • Patient labels should be made available to people considering the surgery, notifying them of product risks and benefits, as well as alternative treatment options.
  • The industry should work alongside the medical field to develop training programs to ensure doctors know how to use the transvaginal mesh products properly and have adequate knowledge of the use of the products. Working Group believes that proper surgical technique, including the right mesh choice and small incisions, impact outcomes.

Overall, Working Group believes that collected evidence leads to the conclusion that transvaginal mesh has an “acceptable safety profile.”

While Working Group’s docket and evidence will no doubt be considered during the public advisory panel deliberations, ultimately, the decision as to the safety and effectiveness of transvaginal mesh in POP repair will fall on the panelists. It will be their decision what the future holds in store for transvaginal mesh, not the manufacturers.

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