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Consumer Reports, DePuy, Hip Replacement, hip replacement products, India, joint replacement, knee replacement, Medical device, metallosis, Stryker Hip Replacements, surgery, University of California
Consumer Reports Urges a Lemon Law For Joint Replacements
by Christy Rakoczy, a J.D.
Manufacturers of hip and knee replacement products made many promises to consumers. This is especially true of DePuy Orthopaedics, Stryker, Zimmer and other manufacturers of the new generation of joint replacement products largely marketed as medical devices that would last longer and provide more flexibility than traditional joint replacement solutions.
Unfortunately, the marketing for many of the new hip replacement products may have turned out to be a lot of hype. In fact, many of the hip replacement products that came on the market in recent years not only fail to last longer but actually appear to have higher failure rates and may cause serious complications for many patients. The extensive problems that patients allege they’ve experienced has even caused Consumer Reports to call for a “lemon law,” on replacement joints.
Consumer Reports Calls for a Warranty On Artificial Hips and Knees
Consumers Union, the policy arm of Consumer Reports, argues that medical device manufacturers should give consumers a warranty on hip and knee replacement products, promising to replace the medical devices at no costs. This suggestion comes at a time when as many as 20 percent of all hip replacement procedures and 10 percent of all knee replacement procedures each year are revision surgeries that are necessary because of problems with the implanted artificial joint.
Consumer Reports believes a warranty would both be fairer to patients who need to undergo repeated surgeries and would prompt medical device manufacturers to make sure their products are safer and more durable.
While this idea has merit as a method of protecting customers, unfortunately a warranty may not be enough. Those whose artificial joints fail often experience significant pain and serious medical complications. A no-cost revision surgery wouldn’t compensate the victims of defective medical devices for these other losses, but a product liability claim can and does allow patients to take action for defective hip and knee replacement devices.
Patients Have Rights When Hip and Knee Products are Defective
A large part of the reason revision surgeries have become so common in recent years is that many of the newer hip replacement products are metal-on-metal devices that were brought to the market under a special FDA rule.
The FDA’s 501(K) clearance rules allow manufacturers to produce and sell medical devices with a fast-tracked approval process and minimal testing provided there are substantially similar devices on the market already. Unfortunately, many of the devices brought to market under these rules have now been recalled when it turned out the products weren’t so safe after all.
DePuy Orthopaedics, for example, instituted a voluntary recall of its ASR™ Hip System after data from a UK joint replacement registry indicated a higher-than-average failure rate. The Stryker Rejuvenate and ABG II Modular-Neck Hip Systems were also recalled because of high failure rates.
The FDA continues to review the safety and efficacy record of metal on metal hip implants. The agency continues to receive adverse event reports with regard to the devices. Commonly alleged problems include:
- Aseptic loosening
- Infection
- Bone loss
- Metallosis (a/k/a “metal poisoning”)
- The formation of pseudo tumors
- Decreased range of motion and limited mobility
- Pain
Patients who experience these complications deserve to have the manufacturer of their defective device pay for revision surgery. This is not all they deserve, though, and a warranty allowing for a no-cost revision procedure doesn’t go far enough. Victims whose lives are affected by defective medical products should also be compensated for time missed from work; for pain and suffering; for emotional distress and for any reduction they experience in their quality of life.
Bio:
Christy Rakoczy, a J.D. from the University of California, is a legal writer and advocate for consumer rights and patient safety. You can read more of her work on the Stryker hip implants, including recall information, complications, and ongoing legal action, at strykerhiprecall.co.
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- CIHI Study Reveals Problems with Metal-on-Metal Hip Implants (earlsview.com)
How about they just give us a new car if the hip doesn’t work……….At least we’d be able to get around. It has been over 5 years since my first hip replacement in my right leg and if i knew then what i’d be going through i would have chosen the pain and being addicted to pain killers if necessary. The odyssey that i have been on has been delirium producing. 3 operations later among the 6 times the unit had “popped out” and six reductions had to be done has proven to be psychologically debilitating. The 501k rule is a joke when it comes to these hips. It’s about money and we’re being used as experiments. 501k needs to be revisited. Or does 501k mean that 501 people were killed from using the replacement hips. All i know is that my life has been ruined and the manufacturer’s lawyers look down their noses and sy 501k, 501k, 501k. Since i don’t have too much to do anymore because my activities have been sharply curtailed’ and i love to talk about it please feel free to call me to discuss 203 885 8950. Enjoy your hips while you still can……………..I do have a sense of humor, just not right now at almost midnight and i can’t fall asleepl
The new agency PCORI is a component of the ACA (U.S. ‘Obamacare’) – PATIENT CENTERED OUTCOMES RESEARCH INITIATIVE. It is authorized to fund research, but do you think any recent grants relate to implanted medical devices? NO! The leadership denies receiving grant applications related to patient outcomes from implanted devices. It is unreasonable for PCORI to expect harmed patients to initiate contacts with researchers to prompt a proposal, but this is apparently the excuse that is being used. It is clear that our legislators, regulators and healthcare providers are not interested in collecting patient outcome measures to inform patients. If you are a researcher who is also a harmed patient – this is your invitation . . . !