Why Foley & Small?

FDA Approval Process

Before a medical implant, such as an artificial hip or knee or cardiac pacemaker, can be sold in the United States, the manufacturer must put the device through testing and trials. The manufacturer then must submit the implant to the Food and Drug Administration (FDA) for approval before the device can be distributed in the United States. At times, implant manufacturers push the FDA to approve a medical implant before the safety and efficacy of the implant have been adequately and fully tested. They do this for a variety of reasons, some good – to make the device available to patients who need it, and some bad – to get the device to market as soon as possible to start making a profit on its sale. Due to its limited resources, the FDA is unable to carefully test and screen all such devices or surgical tools. Sometimes, the FDA approves a new device or implant on the basis of its “substantial similarity” to an already existing device. Unfortunately, this can and has led to instances where a device has been approved and it is later discovered that the device is defective as failures occur after the device or implant has been placed in patients.

FDA Monitoring

Once the device has been placed on the market, the FDA continues to monitor it through post-marketing reports sent in by the manufacturer and through the MedWatch program, an FDA program that allows consumers and health care professionals to report serious side effects or defects, quality control issues and medical errors associated with the device.

Each year medical device makers offer for sale and use hundreds of medical devices, including joint replacement implants, such as knees, hips, and other joints; cosmetic implants, such as breast implants; and offer surgical instruments. Sometimes, unanticipated side effects or defects are discovered after the implant or device is approved for use. If the problem is serious enough, the FDA may issue a warning to the public. If the problem or defect is sufficiently dangerous, the FDA may decide that the risks of the device outweigh its benefits and issue a recall. When this occurs the patient should receive written notification of the recall and information on what to do in response to the defective product.

The FDA is supposed to be responsible for testing and approving each and every medical device for safety and efficacy. However, the truth is that the FDA is unable to carefully test and screen all such devices or surgical tools. In recent years, the approval process for medical devices has been accelerated as multi-national manufacturers motivated by the desire for profit have pushed harder and harder for fast device approval and less rigorous testing. Oftentimes, the FDA simply approves a new device, prosthesis, or implant on the basis of its “substantial similarity” to an already existing device.

Types of Implant Recalls and Claimed Defects

A wide variety of medical implants have either been recalled or challenged in litigation as being defective.

In September 2010, DePuy Orthopaedics, Inc. issued a recall of its ASR Hip Replacement Systems. This DePuy recall followed reports of a higher than acceptable failure rate often requiring another hip replacement surgery within 5 years. It is estimated that the DePuy ASR hip systems have been implanted in 93,000 patients. This hip recall only affects patients who had hip surgery after July 2003. Thousands of patients have already reported experiencing hip implant problems including: serious or ongoing pain, swelling and loosening or dislocation of the hip implant.

Davol Inc., the manufacturer of the Bard Composix Kugel Mesh Hernia Repair Patch, issued the first hernia patch recall in December 2005 after problems were detected with the “memory-recoil ring” which surrounds the device. Further related hernia patch products were recalled in 2007. The ring allows the hernia patch to be folded in half during surgery and then springs back into place when the device is placed at the spot of a hernia. In many cases, however, the memory recoil ring broke after it was implanted, which can lead to serious injury, including bowel perforation, bowel obstruction, and chronic enteric fistulas (abnormal connections between two sections of the intestines).

These are just two examples of defective medical implant recalls.