Defective Medical Devices

The medical device industry is now valued at tens of billions of dollars per year. As manufacturers compete to develop new products, many devices are sold without ever being tested in humans or studied for long-term side effects. Our attorneys represent patients who experience serious injuries as a result of dangerous medical devices.

Recent Medical Device Lawsuits

• Transvaginal Mesh – Surgical mesh used to treat female incontinence has been associated with dangerous complications such as mesh erosion, infection, organ perforation, and prolapse while failing to provide better clinical outcomes than traditional surgical methods.

• Metal Hip Implants – Medical studies show that hip replacements made from metal-on-metal components fail at an alarming rate, often requiring painful revision surgeries and causing serious health risks from the release of metal debris into the blood.

• Morcellators – Power morcellators facilitate the removal of tissue during laparoscopic surgery. When used in hysterectomy or myomectomy procedures, however, morcellators can spread cancerous tissue beyond the uterus to the abdomen and pelvis causing life-threatening health risks not seen with other treatment options.

Doesn’t the FDA Test for Safety?

The U.S. Food and Drug Administration does not test medical devices. Instead the FDA relies on safety data cultivated and submitted by the manufacturers of the devices themselves before approving products for sale. The FDA can impose different approval requirements on manufacturers depending on the type of device.

The most rigorous type of FDA approval is known as Premarket Approval (PMA), which is required for high-risk devices. The manufacturer must provide the FDA with valid scientific evidence showing the device is safe and effective for use in patients before it can be sold to the public.

The danger: The PMA process does not require the manufacturer to conduct post-marketing surveillance of its product to validate the safety data the company submitted to the FDA in gaining approval.

A less stringent or “fast-track” approval process is known as Premarket Notification (PMN). This process is more commonly referred to as 510(k) Clearance. Under 510(k), the manufacturer need only show that the device is “substantially equivalent” to a pre-existing device already approved for sale.

The danger: With 510(k) clearance, a manufacturer can sell its device without testing the product in humans or conducting clinical trials beforehand. In addition, manufacturers can make small changes to existing devices and charge patients a higher price for “improved” technologies.

Example: The recalled DePuy ASR hip implant was approved under 510(k) and implanted in 100,000 patients worldwide. The device was later shown to fail at a rate of 50% after six years in what has been reported as the worst orthopedic disaster in history.

Consult an Attorney About Your Case

If you experienced complications from a defective medical device, we invite you to contact our office to discuss your potential case. Call (866) 808-2424 or send a message using our brief online form at any time. All consultations are free and confidential.