Under the RADAR and Over to Market: FDA 510(k) Submissions for Today’s Vaginal Slings are based on an FDA Equivalent Device that Was Actually Defective

Armand Rossetti

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Dr. Donald Ostergard is a founding member of the American Urogynecologic Society (AUGS) who presented the keynote address at the Society’s 27^th Annual Meeting, which took place between October 19^th and 21^st, 2006. During Dr. Ostergard’s presentation, he expressed concern about an inherent problem in the FDA’s regulatory process. He mentioned that manufacturers were becoming increasingly involved in surgical innovation, and Dr. Ostergard heightened the group's awareness about the current FDA 510(k) regulatory process for approving new surgical implants.

The key is that FDA requirements for new implant clearance are different than requirements for new drug approval. Most notably, the FDA may not require proof of medical device safety and efficacy. Instead, the FDA can grant clearance (approval) for marketing based on whether the product being approved is “substantially equivalent” to a similar “predicate device” that is already on the market. For example, here is a link to a 510(k) that Specialties Remeex International, S.I. (SRI) of Barcelona, Spain submitted on October 12, 2006 for clearance to market a mesh sling for treating stress urinary incontinence (SUI).

In reading SRI's 510(k), notice the heading “Predicate Devices” and SRI's statement to the FDA that its competitor, Gynecare, already had two similar devices on the market. SRI then informed the FDA that any differences between its device and the Gynecare equivalent did not raise new questions of safety and effectiveness. As you might suspect, this type of voluntary reporting on the part of the manufacturer, and the FDA’s subsequent acceptance of the veracity of the statement, may not ensure safety and effectiveness, and Dr. Ostergard provided a cogent example to illustrate that concept.

In the 1990’s a manufacturer sought FDA clearance to market the Vesica procedure for the surgical treatment of female stress incontinence. It was the first convenient surgical kit of its kind marketed for profit. However despite the Vesica’s convenience, surgeons found it was less effective than other options and abandoned it. In 1996, the FDA then approved a second device called the ProteGen sling (Boston Scientific, Inc.), which was similar to the Vesica, except that the manufacturer used a synthetic mesh sling coated with bovine collagen.

As time passed, the ProteGen sling became associated with an unacceptably higher rate of vaginal erosion and dehiscence, and it did not function as intended. The FDA reviewed post market data and suggested a recall. The FDA further described the ProteGen sling as “adulterated and misbranded.”

Reportedly, at least one class action lawsuit resulted from complications associated with the ProteGen sling. Unfortunately at the time of the recall, there were no published investigations; those publications surfaced later in December 1999, after market withdrawal of the ProteGen sling.

Moving ahead to the present, the FDA has based its clearance of the currently used transobturator tape on the claim that the product is substantially similar to transvaginal tape slings. The problem is that the FDA approved the first transvaginal sling in 1998 and that approval was based on substantial equivalence to the ProteGen sling that Boston Scientific recalled in 1999. And the ProteGen received FDA clearance based on its substantial equivalence to the less effective Vesica procedure.

As Victoria L. Handa, MD wrote in her article on Dr. Ostergard’s address (Medscape Today posted January 24, 2007):

"In the current climate, there is no incentive for manufacturers of new devices to provide such data to the public. At present, surgeons considering the use of a new device have to rely on expert opinion, anecdotal experience of colleagues, or marketing information from the manufacturer. Without adequate information, the possibility that associated problems will not be identified until a new device has been used on hundreds or possibly thousands of women is significantly increased. Other examples of products successfully marketed but later withdrawn for safety concerns were cited to emphasize that the medical-legal implications of using unproven products or devices should always be carefully considered. Surgeries involving such devices could be deemed "experimental" by third-party payers or malpractice carriers, with physicians held liable for associated complications and malpractice coverage denied.”