Consumer Reports Says FDA Testing Too Lax for Metal Hip Implants
A May 2012 article in Consumer Reports investigates “Dangerous Devices” – medical implants that have allegedly caused serious health problems in recipients. The article explains that in the United States, implant devices are subject to few pre-market requirements and a manufacturer is required only to pay a $4,000 user fee to the Food and Drug Administration (FDA) in order to sell a device that may bring in millions in profit.
In fact, CR states that, “often, the only safety ‘testing’ that occurs is in the bodies of unsuspecting patients.” Zimmer’s Durom Cup, which has allegedly resulted in Zimmer hip replacement problems in some patients, is one such device. Though the manufacturer has not issued a Zimmer hip replacement recall for the Durom Cup, Zimmer did temporarily suspend sales of the implant in 2008 to investigate patient reports of Zimmer hip replacement problems.
The company released the device back on the market, maintaining that the Durom Cup is safe, effective, and defect-free. It attributed any reported Zimmer hip replacement problems to inadequate technique on the part of surgeons, and issued more detailed surgical instructions.
Zimmer hip lawyer may cite lack of government requirements
In 2011, an Institute of Medicine panel opined that the FDA should overhaul its device regulatory system, stating that current measures do not ensure patient safety. However, Congress appears to be doing just the opposite – the legislative authority is currently debating a new law that would ratify an agreement between the FDA and manufacturers to hasten the process of readying devices for sale.
There is currently no systematic way for the government, researchers, or patients to easily learn about potential problems with medical devices. Unlike a toaster or baby crib, which has an identifying serial number, the only way for patients to learn of implant problems, including potential Zimmer hip replacement problems, is if their doctor contacts them.
Alleged Zimmer hip replacement problems include metallosis
As an orthopedic surgeon, Dr. Stephen Tower of Alaska thought he knew what to expect from his hip implant surgery. According to CR, Dr. Tower had selected the DePuy ASR XL hip implant, since all-metal hips were marketed as an improvement over plastic implants.
Within a year of surgery, Dr. Tower was in almost constant pain, and blood work revealed high levels of chromium and cobalt – a side effect called metallosis that has been cited by plaintiffs seeking damages for alleged Zimmer hip replacement problems. Dr. Tower suffered vision problems, mood swings, anxiety, disturbed sleep, tinnitus (ringing in the ears), and hearing loss.
No Zimmer hip replacement recall
A common Zimmer hip lawyer allegation is that Zimmer did not conduct sufficient trials on the Durom Cup, and that the manufacturer secured FDA clearance under Section 501(k), which requires only that a new device be substantially similar to a device already on the market.
Many plaintiffs allege that this lack of control is partially to blame for their alleged Zimmer hip replacement problems. Nevertheless, despite the brief suspension of sales in 2008, Zimmer has never issued a Zimmer hip replacement recall for its Durom Cup.