FDA Clamps Down on Metal-on-Metal Hips due to Hip Replacement Side Effects
The hip replacement side effects story is getting more concerning every month. Initially, it was the metal on metal or MOM hips used in resurfacing. Then it was the wear particles released by all hip replacement prostheses. Then hip resurfacing devices began failing at an alarming rate. Now the FDA is proposing that metal on metal hips need much more safety research before being placed on the market. This is after an FDA review of more than 100 studies found issues like severe wear from the hips as well as local allergic reactions to the metal wear particles. In addition, metal ions in the blood stream have been found in patients who have undergone hip resurfacing. The FDA issued a statement on the issue on their web-site: “metal-on-metal hip implants have unique risks in addition to the general risks of all hip implants” because “metal release will cause some tiny metal particles to wear off of the device around the implant, which may cause damage to bone and/or soft tissue surrounding the implant and joint. “The soft tissue damage may lead to pain, implant loosening, device failure and the need for revision surgery,” according to the communication. “Some of the metal ions released will enter the bloodstream and travel to other parts of the body, where they may cause symptoms or illnesses elsewhere in the body.” Two product recalls have plagued these devices in recent years due to high failure rates and the hip replacement side effects. Based on this the FDA implored surgeons to warn their patients about these devices. They stated that surgeons should, “Inform patients about the benefits and risks of metal-on-metal hip implants, including the risk that the hip implant may need to be replaced. Also discuss the patient’s expectations and review the potential complications of surgery with a metal-on-metal hip implant.”Learn about Regenexx procedures for hip conditions.