The U.S. Food and Drug Administration recently received a letter from the Consumers Union, signed by more than 11,000 people, that pressed the agency to adopt a new rule that would change how metal-on-metal hip implants can be approved before going to market.
The group is urging the FDA to review the current premarket approval (PMA) process, which Consumers Union asserts would ensure only the safest and most effective products are sold to the public. Specifically, the group stated that it hopes the FDA will take a closer look at all high-risk hip implants and medical devices and place them in new categories. These new classifications would be based on the clinical evidence that shows their efficacy and safety rating before they are sent to market.
“Thousands of patients have been seriously injured by faulty metal on metal hip implants and other medical devices that were never properly tested before being cleared for sale,” said Lisa McGiffert, Director of Consumers Union’s Safe Patient Project. “It’s time to stop experimenting on patients and require more rigorous safety testing of all high risk implants to prevent flawed medical devices from reaching the market.”
In the letter, Consumers Union also expressed its support for a recent proposal that calls for all hip implant manufacturers with products already on the market that fall into the “high risk” category to be labeled as such within 90 days. The letter also mentions that Consumers Union agrees that it is a major step forward that manufacturers would have to demonstrate safety and efficacy before receiving approval, but adds that more should be done.
“[A]t this time we are skeptical that any metal on metal hip implant could be safe for patients,” the group noted. “Because of that, we urge the FDA to push all manufacturers of metal-on-metal hips to remove their products from the market, because of the high failure rates and high numbers of adverse events, especially experienced by women.”
No guarantee
The union stressed that the current system in place includes FDA-issued alerts regarding the potential health effects of defective implants, but added that this does “not guarantee” that patients who received the implants are given all the information they need to solve their health issues. The group pointed to the UK’s advisory system, which encourages all patients with implants to receive yearly tests, as a strong example of how the U.S. could model its advisory system.
Many say the problem with hip implants begins with defective designs that are not addressed by the manufacturer. According to The New York Times, Johnson & Johnson conducted an internal analysis after a 2011 recall of its hip implant product, and found that its device would fail within five years in almost 40 percent of all patients who had it inserted.
It’s instances like these, the group said, that are indicative of the “irresponsible behavior” of these manufacturers, which “must stop.”
“Requiring a more thorough review up front, as the current order proposes, will help to keep flawed devices from the market,” the group said.
If these proposals are made into rules, it will be more important than ever for companies to focus on product testing to avoid high costs later on.