How the FDA Confirms the Safety of Medical Devices and Implantable Incontinence Treatments

Nancy Muller Health Pro
  • Much publicity and controversy have surrounded the question of drug safety in recent years. As a result, the amount of efficacy data requested by the FDA for pre-market approval (PMA) of a prescription drug now pales in relation to the volumes of data aimed at proving a new drug to be safe. Unprecedented attention is also being given, with good reason, to post-market surveillance data, for the first time.


    The same rigor, however, is missing in the medical device sector.


    As Dr. Diana Zuckerman, President of the National Research Center for Women & Families, so eloquently shared in her Congressional testimony last summer before the House Subcommittee on Energy and Commerce, almost all of the medical devices approved by the FDA each year are still cleared through a "quick and easy" process - known as the 510(k) process.

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    Under these requirements - intended when issued decades ago as a temporary means of government scrutiny - device companies need only to prove that their new device is "substantially equivalent" to a product that was on the market BEFORE 1976. It does not matter if the previously sold product was subsequently found to be unsafe and is no longer sold. In fact, many devices approved through this process today are not like ANY devices on the market over 30 or more years ago. Instead, they are constructed of different materials using different technologies, perhaps even for different uses.


    Unfortunately, many implantable, medical devices used to treat incontinence and other gynecological and urological conditions were not required to undergo clinical trials before being released commercially. Differentiation among them by you, the consumer, is virtually impossible. Clinical trials are needed to unearth risk factors and measure the likelihood of adverse outcomes from using such devices so that patients can be more carefully selected as candidates for their application... or to send the product back to the lab for further development.


    Of course, the device is only part of the equation for safety and desired outcomes. The other essential element is the training and experience of the physician and the entire support team.


    In recent months, progress was made under the banner of patient safety in requiring hospital registries for implanted devices, using unique identifying numbers, to keep a recalled medical device from being inadvertently implanted, among other things. This was largely the result of a coalition led by Premier, a hospital group purchasing organization, and one in which the National Association For Continence (NAFC) has actively participated.


    Still, much needed policy change to strengthen the review and oversight role of the FDA has languished. The FDA's current means of collecting post-market outcomes data on devices, by way of self-reported, anecdotal stories posted by doctors, remain grossly inadequate and incomplete.


    As a nation, we can do better. Until consumers and their doctors are assured of safeguards and have unfiltered, unencumbered access to data about the experience of others using these devices, you as patients are left completely on your own to gamble. If you or a close friend are considering surgery for incontinence or other pelvic floor dysfunction such as prolapse, visit to know what to ask your doctor BEFOREHAND or call us at 1.800.252.3337 (1.800.BLADDER) for guidance.


Published On: September 22, 2008