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Shezad Malik MD JD
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FDA and Dallas Defective Hip Attorney Warns About Metal on Metal Hips

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The US Food and Drug Administration (FDA) issued guidelines for defective implanted metal-on-metal (MoM) hips. MoM hip implants have been subjected to many manufacturer recalls and allegations that government regulators in Europe and the United States did not disclose to injured patients about the risks of these devices.

What is the problem with Metal on Metal Hips?

Metal release is the root of the problem. This happens during the daily wear and tear of the implant's metal ball and metal cup grinding against each other. Other parts of the hip implant where 2 components connect also can cause metal release.

According to the FDA, the metal particles can lead to bone and soft tissue damage surrounding the implant, known as "adverse local tissue reaction". Soft-tissue and hip bone damage can lead to pain, device loosening and failure, and the need for revision surgery.

Metal on Metal Hip Metallosis

Metal ions released from the implant can enter the bloodstream, affect other organs, and trigger illness in a systemic reaction, called metallosis. Skin rashes, cardiomyopathy (weakening of the heart), and kidney damage can occur as a result of metallosis. According to the FDA, makers of all-metal, total-hip replacement products will now have to file approval applications for the strictest level of agency device review.

DePuy ASR Lawsuits

The DePuy unit of New Brunswick, New Jersey-based Johnson & Johnson (JNJ) recalled 93,000 metal-on-metal hip devices in 2010 after more than 12 percent failed within five years. J&J faces more than 10,000 lawsuits related to the recalled hips in federal and state courts.

Similar product liability lawsuits have also been filed over other metal-on-metal implants, including the DePuy Pinnacle hip, Biomet M2A-Magnum hip, Stryker Rejuvenate and ABG 2, Smith and Nephew and Wright Conserve hips.

To report problems with MoM hip implants, contact MedWatch by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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