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Premarket review process for some medical devices raises safety concerns
In an attempt to obtain speedy clearance to market from the FDA, some manufactures misrepresent the characteristics and/or intended uses of devices resulting in the sale and use of unsafe and ineffective medical devices, often resulting in serious pain, suffering and even death to the recipients of those medical devices.

Before a medical device can be marketed and sold in the United States, the Food and Drug Administration (FDA) must review the device and make a determination about its safety and effectiveness. Once the FDA is satisfied with the safety and effectiveness of a medical device, it will clear the device for marketing to the public. Unfortunately, in an attempt to obtain speedy clearance to market from the FDA, some manufactures misrepresent the characteristics and/or intended uses of devices resulting in the sale and use of unsafe and ineffective medical devices, often resulting in serious pain, suffering and even death to the recipients of those medical devices.

Food and Drug Administration (FDA), Institute of Medicine (IOM) and Government Accountability Office (GAO) critical of 510(k) process

Citing its findings that from 2005-2009 three out of four recalled high risk medical devices had been cleared by the FDA under the 510(k) process, the Institute of Medicine (IOM) has called for eliminating the 510(k) process. Echoing the IOM’s findings, the Government Accountability Office (GAO) found that 83 percent of roughly 700 medical devices recalled every year are Class II medical devices that received premarket approval under the 510(k) process, concluding that the FDA should enhance its oversight of recalls.

Even the FDA acknowledges the breakdown of the 510(k) process, at least with respect to all-metal artificial hips, and recently announced it will be proposing new rules to tighten regulation of those devices. The rule would require manufacturers of all-metal artificial hips to provide clinical data showing that the all-metal hips they have already placed on the market are safe and effective. If a manufacture fails to provide clinical data or the data fail to show that the device is safe and effective, the device will be pulled from the market. Similarly, if a manufacture wishes to obtain approval for a new all-metal artificial hip, the FDA will only accept clinical data, not a predicate artificial hip as it had in the past, to make a determination as to the safety and effectiveness of the device. The FDA will also issue new guidance to doctors that they monitor their patients who have received all-metal hip replacements and to test the level of metallic ions in the blood of those patients experiencing pain or other symptoms associated with the potential failure of their hip replacement.

Premarket approval of medical devices

There are two main premarket review processes for medical devices used by the FDA: premarket notification (also called the 510(k) process) and premarket approval (PMA).

  • Premarket notification — 510(k) review — Premarket notification, also called 510(k) review, is the medical device premarket review process used in about 90 percent of medical device applications. It is available for most Class I and Class II medical devices (medical devices which pose little risk of illness or injury), provided the manufacturer can show there exists a lawfully marketed medical device to which it is "substantially equivalent" in safety and effectiveness. The lawfully marketed device to which the new device is being compared is called a "predicate." A medical device is substantially equivalent to a predicate if it has the same intended use as the predicate.
  • Premarket approval (PMA) — For Class I and Class II medical devices for which no predicate exists, and for Class III medical devices (medical devices that support or sustain human life and present a potential, unreasonable risk of illness or injury), premarket approval (PMA) is the process used by the FDA to evaluate the safety and effectiveness of the device. PMA is the most-stringent type of premarket review, often taking years to complete. In PMA review, the manufacture must conduct extensive research, including clinical trials, to collect data proving the device’s safety. The data is then added to the PMA application and transmitted to the FDA. Only if the scientific evidence and data filed with the PMA application is sufficient to prove that a medical device is safe and effective for its intended use, will the FDA clear the device for market.

High-profile examples of 510(k) premarket review failures

Hip and knee replacement implants and surgical mesh are two high-profile examples of situations in which the 510(k) process failed to adequately protect the health and safety of millions of consumers.

Knee and hip replacement implants. With an estimated 1 million people getting an artificial hip or knee every year, the artificial hip and knee industry is worth roughly $7 billion a year. Many of these hip and knee replacements and implants, such as the all-metal Stryker's ABG II modular neck hip implant stems, Stryker’s Rejuvenate, DePuy’s ASR Acetabular System and DePuy’s ASR Hip Resurfacing System, were deemed safe and effective by the FDA who relied on the implants’ similarity to others made of both plastic and metal to make its decision. Unfortunately, the all-metal hip implants proved to be neither safe nor effective. Unlike the plastic and metal hips which don’t typically fail for at least 15 years, the all-metal hips started failing at high rates shortly after implantation. Another problem with the all-metal artificial hips was the release of minuscule particles of metal into the body causing potentially disabling tissue and bone damage.

Surgical mesh. Implantable surgical mesh is another case in which the 510(k) review process failed to identify an unsafe medical device. In the late 1990’s, the FDA cleared for market Boston Scientific’s ProteGen Sling, a surgical mesh for implantation into the vaginal wall intended to treat urinary incontinence. In its 510(k) application, Boston Scientific cited as its “substantially similar” predicate a surgical mesh implanted in the abdomen to treat hernias — and even though the predicate was approved for a different treatment and implantation in a totally different part of the body, the vaginal surgical mesh was cleared for market by the FDA. Johnson & Johnson subsequently received 510(k) clearance for Gynecare TVT, its version of vaginal surgical mesh, based on its similarity to Boston Scientific’s ProteGen Sling.

By 1999, Boston Scientific had received so many complaints of pain, infections and injuries it voluntarily recalled the ProteGen Sling. Despite similar problems with Johnson & Johnson’s Gynecare TVT, it did not issue a recall and has faced hundreds of lawsuits over its safety and effectiveness.

Seek legal representation

If you are the recipient of an all-metal artificial hip or other implanted medical device and are experiencing pain or other symptoms you believe to be related to the possible failure of your medical device implant, your first step is to see your doctor and obtain the necessary medical treatment. Next, you should schedule a consultation and case evaluation with an attorney experienced in handling defective medical device litigation.

Keywords: premarket notification, 510(k) review, premarket approval, defective hip replacement, defective surgical mesh
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