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Rushed Medical Device Approvals Endangering Patients

Oct 28, 2008 | Parker Waichman LLP

Thousands of medical devices are approved every year in the U.S. without proof of their effectiveness.  The Food & Drug Administration (FDA) defends this process - known as 501(k) approvals - by claiming that it promotes innovation.  But a recent article in The New York Times raises serious concerns that 501(k) approvals might actually be putting patients at risk.

According to The New York Times, when Congress gave the FDA authority over medical devices in 1976, it allowed a quick review process for any new product deemed “substantially equivalent” to something already on the market.  That expedited process became known as a 510(k) review under the relevant section of the law.  But in 1976, devices played a much smaller role in medicine.  Critics of the 510(k) review argue that the complexity of the thousands of devices on the market today makes the expedited process inadequate.

The FDA's policy of fast-tracking medical devices contrasts greatly with its process for drug approvals.  The FDA requires that a new medication be studied in thousands of people to see if it is both safe and effective before it will approve it for market.  But medical device makers must simply demonstrate that a device does what they say it does, and that it poses no undue safety risks.  Unlike a new drug, a device approved under the 501(k) rules does not have to be shown to be effective.

Last year, the FDA reviewed 3,052 devices under the 510(k) process and cleared 2,640 of them.   By contrast, of only 41 novel devices required to go through a more comprehensive, evidence based process last year, only 27 were approved.

Some medical devices that have undergone 501(k) approvals have been found to be defective later on.  For instance, Protegen, a synthetic sling implanted under a woman’s bladder to prevent stress incontinence that was granted 501(k) approval in 1996 was recalled three years later  because of a high rate of complications.  Last year, Medtronic Inc. recalled its Sprint Fidelis defibrillator lead, which had undergone the same process, after it was found to have a higher than normal facture rate and was implicated in the deaths of five patients.

The 501(k) approval of MammoSite, a device used to treat breast cancer by inserting radioactive seeds into the tumor site, has also raised concerns. The treatment has been around for six years, and has been used in roughly 45,000 breast cancer patients. MammoSite appeals to many patients because of its shorter treatment periods (5 days vs six weeks for traditional radiation), and because it allows them to avoid many side effects of standard radiation.  Unfortunately, no one really knows if MammoSite is as effective in treating breast cancer as traditional treatments.  In fact, it is still considered highly experimental.  

When MammoSite was approved in 2002, the FDA based its decision on a study of only  25 women that did not even address the question of its effectiveness.  While the FDA did require that MammoSite bear a label warning that the system had not been shown to be a substitute for conventional radiation, its doubtful many patients ever see that warning.  In fact, doctors are not even required to tell their patients that MammoSite is unproven.

Critics of MammoSite also argue that it never really met the  "substantially equivalent" standard required for 501(k) approval.  MammoSite was able to undergo 501(k) review because its maker claimed it was "substantially equivalent" to a device called GliaSite which also delivers radioactive seeds to tumor sites.  But GliaSite is used for brain tumors, and patients who use it have far fewer proven options than breast cancer.  For these patients, a treatment that has not been fully proven effective might make  sense.  But critics of MammoSite argue that because traditional radiation has been proven to be very effective in treating breast cancer, use of the device is placing these patients at an unnecessary risk.

Many patient advocates are pushing Congress to change the law regarding 501(k) approvals.  Next month, the Government Accountability Office is expected to release report on the effectiveness of the process.   Many critics of 501(k) approvals are hoping that report will be the impetus for Congress to change the law.



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