The FDA, Food and Drug Administration, says all-metal hip implants can cause soft-tissue damage and pain by shredding metal components when walking or running.
All-metal hip implants were made to last longer than traditional implants, which are made from ceramic or a metal ball with plastic socket. The all-metal hip implants have a metal ball and metal cup. The wear and tear of the metal ball sliding against the cup can cause damage to bone and soft tissue around the implant. This damage could lead to further surgery to replace the implant.
The FDA estimates 500,000 people in the US have had all-metal hip surgery and many of them are having issues early on. The biggest maker of all-metal devices, Johnson Johnson, recalled the ASR hip implant in 2010 after having safety problems. Smith Nephew stopped making a components of it hip implant system after they received a high level of patients reporting problems. Stryker Corp also recalled some it’s components due to corrosion risks.
All-metal hip replacements were made to last longer than the traditional hip replacements which are made of ceramic or plastic. The traditional hip replacements only last about 15 years. Companies started marketing all-metal hip replacements, many without testing them first. Now a large amount are failing soon after implantation. Thousands of patients are having to undergo the painful, expensive surgery again.
Dr. William H. Maisel, deputy director for science at the FDA told The New York Times the agency’s proposal would require makers of all-metal hips to produce clinical data to justify their use because of the “large number of patients who received these products and the numbers of adverse events associated with them.”
The FDA wants to place stricter rules. Rules that could stop manufacturers from selling the implants. The new regulations proposed would require manufacturers to prove the all-metal components are safe and effective before they could sell existing ones or obtain approval for new all-metal designs. Under the old rules, companies are not required to conduct clinical studies on them before selling them. They only have to show that their hip implant resembles ones already on the market.
Medical devices were first regulated under federal law in 1976. The FDA plans to close a loophole, in the 1976 law, by using powers that Congress gave the FDA to deal with medical devices. The FDA says surgeons should recommend all-metal hip replacements only if the benefits outweigh the alternative hip replacements.
According to Reuters, the US Health regulator said there was not enough data to specify the concentration of metal ions in a patient’s body or blood pressure that would create negative effects.