The FDA has faced reports of problems with metal-on-metal hip implant devices for years. Now the agency is responding to growing backlash and beefing up its oversight of the products.
Regulators think that "there is insufficient evidence and information" that would ensure the "safety and effectiveness of these devices," the FDA said on its website. So the agency issued a final order this week that requires companies to submit a premarket approval (PMA) application for two types of metal-on-metal hip replacement devices, including one with a cemented acetabular component and another with an uncemented acetabular component.
Companies have until May 18 to submit a PMA application for related products. The application should include "any risks known, or that should be reasonably known" about the device, the product's effectiveness and "full reports of all nonclinical and clinical information from investigations on the safety and effectiveness of the device," the FDA said.
The latest action builds on the agency's previous efforts to crack down on metal-on-metal hip implant makers. In 2013, regulators issued a proposed order that would require companies to submit PMA applications for related devices. The same year, the FDA issued a safety communication to orthopedic surgeons, healthcare providers and patients that warned of "unique risks" associated with the products.
|Johnson & Johnson's ASR all-metal hip implant--Courtesy of Johnson & Johnson|
In some implants, the metal ball and metal cup can slide against one another when a person walks or runs. The devices can also release metal, which damages bone and soft tissue that surround the implant and joint. Eventually, the erosion can lead to serious problems such as device failure or the need for revision surgery, the FDA said.
Meanwhile, devicemakers such as Johnson & Johnson ($JNJ) continue to deal with pushback over allegedly defective all-metal hip implants. In 2011, the FDA flagged manufacturing problems for devices made by the company's DePuy unit. In 2013, J&J stopped selling its related devices after the FDA issued more stringent regulation for all-metal hip products.
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