Today, the Food and Drug Administration (FDA) proposed new rules that may stop manufacturers from selling faulty all-metal hip implants. The FDA’s proposal comes after an estimated 500,000 people in the United States received hip implants that can fail early – one of the biggest device failures in decades.
Congress granted the FDA the power to deal with medical devices in 2012, and this action represents the agency’s first act of authority. The FDA’s proposed order will require manufacturers of metal-on-metal total hip replacements to go through a complete premarket approval process, including submitting a full application.
Under the current FDA regulations, medical device companies can get approval for devices by showing that they are similar to products already on the market. No clinical studies are required before making them available to the public. This approval process is referred to as the 510(k) premarket notification program.
According to the FDA, all-metal devices were originally marketed before the Medical Device Amendments of 1976 gave the agency authority to regulate them. So, these implants were classified as high-risk devices but were regulated as moderate-risk products. The proposed order is aimed at better controlling these types of devices and is intended to close the loophole in the 1976 law. It could take a year before the new rules are finalized.
FDA’s Current Recommendations for Doctors and Patients
The FDA released a safety communication regarding all-metal hip implants along with its proposed order today. In the communication, it stressed that “metal-on-metal hip implants have unique risks in addition to the general risks of all hip implants.”
Specifically, the communication refers to adverse reaction to metal debris (ARMD). This condition occurs when “tiny metal particles [that] wear off of the device around the implant, which may cause damage to bone and/or soft tissue surrounding the implant and joint.”
For patients with all-metal implants, the FDA recommends:
- Those who are not experiencing discomfort or pain in the joint should still follow up with their surgeon every 1-2 years.
- Anyone who experiences swelling, numbness, pain, difficulty walking or noises like grinding or popping should speak to a doctor immediately.
- Those who experience changes in general health should inform their doctors that they have an all-metal hip implant.
For orthopaedic surgeons, the FDA recommends they:
- Conduct clinical evaluations every six months for patients suffering side effects from an all-metal implant.
- Consider soft tissue imaging such as MRI, CT and ultrasound for patients with symptoms and weigh the risks and benefits of these tests.
- Monitor metal ions levels in symptomatic patients.
All-Metal Devices Lead to Lawsuits
Many companies that sold metal-on-metal implants marketed them as being more durable than traditional hip implants made from plastic and metal. The problem was that they were not adequately tested in clinical trials.
After a number of these devices were already implanted, researchers conducted studies on the failure rates. The studies revealed that the revision surgery rate for people with all-metal implants was much higher than those who received other types of implants.
Thousands of people who received untested all-metal hips later required revision surgery to correct defective products after they failed prematurely. The tissue and bone damage from metal ions has left many all-metal hip recipients with disabling, chronic pain.
Many of these patients filed lawsuits against manufacturers of metal-on-metal implants, and companies have set aside billions of dollars to cover the costs of litigation and settlements. Johnson & Johnson has been embroiled in lawsuits stemming from its DePuy ASR and Pinnacle metal-on-metal hip implants and expects to spend more than $3 billion on the DePuy ASR cases alone.
More than 6,200 DePuy ASR lawsuits have been consolidated under multidistrict litigation (MDL) in the Northern District of Ohio, and more than 3,000 DePuy Pinnacle hip lawsuits have been consolidated under an MDL in the Northern District of Texas.