A hip-replacement surgery is a complicated medical procedure that requires a long and often painful recovery period. In 2000, the FDA approved the Pinnacle artificial hip developed by DePuy Synthes, an orthopedic and neurosurgery franchise acquired by Johnson & Johnson in 1998. These all-metal hip implants were touted as a durable, long-lasting solution for patients who needed to undergo hip-replacement surgery, with thousands implanted between 2000 and 2013.
But by 2010, investigations into the safety and durability of the Pinnacle implant unveiled serious safety concerns over metal-on-metal artificial hips. Read on to learn about the health risks associated with these devices as well as legal recourse available to recipients of all-metal hip implants.
Common Medical Complications of Metal Hip Implants
All-metal hip implants are typically made of chromium and cobalt. When the metal ball and cup grind together over time, tiny particles of these metals can leak into the bloodstream and surrounding tissue. Exposure to these toxic chemicals can cause:
- Bone deterioration
- Tissue death
- Metallosis (blood poisoning)
- Skin rashes
- Extreme pain
- Mobility problems
- Device failure
- Need for revision surgery
- Heart complications
- Renal failure
- Thyroid problems
FDA warning against the Pinnacle implant
According to a safety warning released by the FDA in 2013:
“Soft tissue damage may lead to pain, implant loosening, device failure and the need for revision surgery (a surgical procedure where the implant is removed and another is put in its place). Some of the metal ions released will enter the bloodstream and travel to other parts of the body, where they may cause symptoms or illnesses elsewhere in the body (systemic reactions).”
The FDA says that, despite some risks, these devices help improve the quality of life for millions of Americans.
“The system for the most part works fairly well,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Radiological Devices and Health, “but that does not discount the importance about being vigilant about addressing safety issues particularly as technologies continue to evolve.”
Diana Zuckerman, president of the National Center for Health Research, isn’t buying it. “The devil’s always in the details,” said Zuckerman. “The fact that the FDA is now going to change the process—on the one hand it’s terrible so maybe any change is for the better. But the track record over there is not good.”
Human Guinea Pigs
Attorney Mark Lanier helped win the $1.04 billion verdict against DePuy and Johnson & Johnson in a Dallas-based trial that dragged on for more than eight weeks in late 2016.
"The problem is the DePuy, Johnson & Johnson Pinnacle metal-on-metal [implant] was never tested in one single human being before they started selling it," said Lanier. "And the company basically made guinea pigs out of everyone who received it."
In 2013, an article published in the New England Journal of Medicine revealed that studies "might have identified the high revision rate of the ASR," another of DePuy’s all-metal implants. The ASR was recalled in 2010. Depuy and Johnson & Johnson paid more than $2.5 billion to resolve those lawsuits.
"As thousands of Americans are painfully learning, there are unknown risks with devices that enter the market without clinical data showing safety and effectiveness, and implanted body parts cannot be recalled as easily as defective auto parts," wrote the study’s authors.
Failure to Warn
New evidence shows that manufacturers of all-metal hip implants likely knew about the risks long before physicians and the general public were warned. As a result, billions of dollars have been awarded to patients who needed surgery after their all-metal hip implants failed.
If you have an all-metal hip implant and are concerned about the risks, talk to your health care provider today. Specifically, if you develop any of the following symptoms—pain or swelling in the hip or groin area, numbness, or difficulty walking—seek immediate medical attention. An experienced defective medical products attorney can help you protect your rights, and get you the compensation you deserve if you’ve been harmed by an all-metal hip implant.