FDA Raises Serious Personal Injury Concerns with All-Metal Hip Replacements

An estimated 500,000 individuals had hip replacement surgery in the last decade and many had an all-metal hip implanted. Many people, as well as their doctors, were attracted to the latest hip replacement technology and wooed by ads that featured celebrities and athletes. As highlighted in the marketing pieces, the promise of being able to do strenuous activity was a big draw. But now some patients are dealing with pain and other complications from the devices.

“There was a patient demand to get these implants on the misconception that the latest was the best,” said Dr. Henrik Malchau from the Massachusetts General Hospital in Boston.

The Food and Drug Administration (FDA) is now mandating that all manufacturers conduct emergency studies on the metal hips. Some patients are experiencing pain as a result of metallic debris that is coming off the artificial hip. Others are developing gray fluid around their hip. And some are showing signs of abnormal tissue growth around the hip and tumors.

Women and older individuals are more at risk to complications from all-metal hips. Patient safety advocates say that more testing should have been done before these devices were allowed to be mass marketed. The thinking that new is always better definitely did not come true with these devices.

The FDA does not require clinical trials on most all-metal hips. They are only required to be tested in the lab by machines to simulate use. Critics say these simulations are conducted under conditions that do not mimic real-world scenarios of movement and strain. All-metal hips are less resilient, which is why some individuals are dealing with tissue, muscle, and neurological concerns even in the first year after surgery.

Manufacturers are under pressure to come out with new products that utilize the latest technology to stay ahead of the competition. But recent headlines show that across manufacturers and products, new devices and drugs do not always live up to the hype. Medtronic’s new heart device fractured after being implanted in some patients and caused 12 deaths. Artificial spinal discs proved no better than what had been in use. Avandia, a blockbuster diabetes drug, caused heart attacks, and the medical community went back to medicines that had a long-term history of helping diabetes patients.

“The vast majority of the ‘innovations’ on which we have spent money with respect to orthopedics over the past two decades have not resulted in improved patient outcomes,” said Dr. Kevin J. Bozic, an orthopedic surgeon and professor at the University of California, San Francisco.

Previous artificial hips were made of metal and plastic. These devices have been found to remain safe and work for 95 percent of patients, even after a decade of use. Patient safety advocates say problems with the all-metal hips could have been prevented, or at least lessened, with more rigorous testing, phasing in of the product to select patients, and more consistent product records.

Individuals who are dealing with serious injuries and concerns after having an all-metal hip implanted should seek immediate medical attention and the expertise of a personal injury lawyer.

Robert I. Briskman is a Chicago personal injury lawyer and Chicago personal injury attorney with Briskman Briskman & Greenberg. To learn more call 1.877.595.4878 or visit http://www.briskmanandbriskman.com/.

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