July 3, 2014
April 7, 2024

510(k) Loophole in Medical Device Cases

In the past 3 years, several recalls of medical devices has prompted concern regarding a major loophole in the 510(k) approval process. Under the 510(k) application, the FDA will approve a device based on a predicate provided that it is “substantially equivalent” to the predicate device. This means that the FDA does not require these devices to undergo clinical testing or demonstrate that it is safe and effective. Once the FDA has approved the device, it can be used as a predicate for future devices.

In August 2010, DePuy recalled its ASR and ASR XL hip implants after receiving information from the UK National Joint Registry which showed a five-year revision rate of approximately 12% for the ASR Hip Resurfacing System and approximately 13% for the ASR XL Acetabular System. An estimated 93,000 units were recalled worldwide. The ASR System was predicated on three different devices. Had testing been required, the loosening of the implant and revision rate could have been detected prior to approval.

This recall follows in the footsteps of the Zimmer Durom hip implant recall in 2008 and the recall of the R3 metal liner in 2012. On July 6, 2012, Stryker recalled its Rejuvenate and ABG II modular neck stems in the United States.

Given the level of concern regarding the use of metal-on-metal hip implants and injuries associated with these implants, the FDA held an advisory committee meeting in June 2012. The FDA indicated that recent data from orthopaedic implant registries, peer reviewed journal publications and presentations at scientific meetings have shown that these metal-on-metal hip systems have been linked to serious side effects including psuedotumors, early device failure, the need for revision surgery and complications associated with metal ion exposure.

On January 17 2013, the FDA issued a Safety Communication which provided recommendations for surgeons implanting metal-on-metal hip implants and associated adverse events. Additionally, the FDA decided that metal-on-metal hip implant systems should be ordered to submit premarket approval (PMA) applications forcing hip manufacturers to perform clinical studies on the implant prior to seeking approval.

Similarly,  in the transvaginal mesh litigation, vaginal mesh implants were approved through the 510(k) process and solely required that the product be “substantially equivalent” to a predicate device. In 1996, Boston Scientific received approval for its ProteGen sling and a mere 3 years later in 1999, Boston Scientific recalled the ProteGen sling after learning that it caused erosion, severe pain and infections.

Ethicon, a subsidiary of Johnson & Johnson, used ProteGen as its predicate device for the Gynecare TVT. Gynecare TVT remains on the market, however, Johnson & Johnson recently removed GynecareTVTSecur System, GynecareProsima Pelvic Floor Repair System, GynecareProlift Pelvic Floor Repair System, and GynecareProlift+M Pelvic Floor Repair System from the market.

Even more disturbing is the fact that Mentor Corporation produced the ObTape product in 2003 which was predicated on ProteGen and remained on the market until it was recalled in 2006. Much like ProteGen, ObTape was removed from the market after women complained of serious complications, including erosion, organ perforation, pelvic pain and pain during intercourse.

On July 13, 2011, the FDA issued a Safety Communication to physicians and patients stating that vaginal mesh had been associated with complications including erosion through the vaginal epithelium, infections, pain, urinary problems and bladder perforation. The FDA found that there was very little evidence to support the use of mesh in pelvic organ prolapse and an advisory panel recommended that the FDA reclassify the mesh as a “high-risk” product.

Disturbingly, it has been reported that approximately 300,000 women have received vaginal mesh implants in the United States in 2010. The FDA has asked 31 manufacturers including Ethicon (J&J subsidiary), C.R. Bard and AMS to conduct three years of trials on the safety and effectiveness of their products including providing adverse event reports.

On March 22, 2012, Congressman Edward J. Markey introduced the SOUND Devices Act (The Safety of Unused and New Devices Act) which is meant to close the 510(k) loophole. The Act would provide the FDA with the ability to reject devices whose design might mirror a major design or manufacturing flaw that was found in the predicate device.

On April 29, 2014, the FDA announced that it would follow the advice of the advisory panel and has reclassified transvaginal mesh products used for pelvic organ prolapse as "high risk." The FDA found that mesh products can cause a variety of side effects such as pelvic pain, pain during intercourse, urinary infections, recurrent incontinence and erosion. Moving forward, transvaginal mesh products used for pelvic organ prolapse will be required to go through the PMA process. This means that the manufacturers will have to perform studies and provide evidence that the mesh products are safe and effective.

The events over the past 3 years have demonstrated that the approval process for medical devices must be reformed. In one of the transvaginal mesh trials that resulted in $3.35 million in compensatory injuries and $7.76 in punitive damages, it was revealed that Johnson & Johnson’s advertising and marketing expenses were $20.9 billion last year, approximately $57 million a day. Clearly if that amount of money is spent on marketing and advertising, it can also be spent on clinical trials and studies to make certain that their products are safe and effective.

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