Ann Morrison, DePuy, Food & Drug Administration, Hip Replacement, Hospital for Special Surgery, Johnson & Johnson, Medical device, New York TImes
Complaints Surge About Crumbling Artificial Hips
on August 23, 2011 Source: fairwarning.org
As researchers scramble to assess the health dangers of flawed artificial hips, the federal government has received a flood of new complaints about the devices.
An analysis by The New York Times reveals that the Food and Drug Administration has been deluged with more than 5,000 reports since January about several types of so-called metal-on-metal hips. That is more than the overall complaint total for artificial hips for the previous four years. Most are from patients who either had, or will have, the devices removed because they failed long before their expected duration of at least 15 years.
The growing number of complaints raises the likelihood that all-metal replacement hips will become the most expensive medical implant problem in several years, the biggest since the 2007 Medtronic recall of a widely used heart device.
The hip implants, which have an artificial ball and cup both made of metal, tend to shed tiny particles of cobalt and chromium as they wear, causing crippling pain in some patients. Researchers still are struggling to understand the tissue damage caused by the debris.
Hip replacement is one of the most common medical procedures in the U.S. and, according to one estimate, roughly 500,000 patients have the all-metal implants. Amid the mounting complaints, however, most surgeons have switched to replacements that combine metal and plastic components.
“It is like playing Russian roulette,” said Dr. Geoffrey H. Westrich, an orthopedic surgeon at the Hospital for Special Surgery in New York, who no longer uses all-metal implants.
One of the most troubling devices has been the A.S.R., or Articular Surface Replacement. Recalled last year by Johnson & Johnson, it accounted for 75 percent of the complaints reviewed by the Times.
Under FDA rules, many all-metal devices were sold without testing on patients or a means of tracking their performance. In May the FDA took the unusual step of ordering producers to study the devices’ failure rate and health risks, but the companies have faced obstacles in conducting sound studies.
For many patients, any changes will come too late. In 2008, Ann Morrison, a 50-year-old physical therapist from Newark, Del., received all-metal replacements for both of her hips and soon experienced pain, rashes and inflammation.
Morrison had the devices replaced last year, but by then the metal debris had caused so much tissue damage that she now needs a brace to walk. She called the FDA’s order for medical studies a “joke.”
“We will be the little crash test dummies here until they figure out the health ramifications for us down the road,” said Morrison, who has sued the DePuy division of Johnson & Johnson, the manufacturer.
Scientists Urge Scrapping FDA System for Screening Medical Devices
Safety Problems Spur Order for Follow-Up Studies on Artificial Hips
Posted in Medical Errors, News & Notes, Product Hazards and Recalls
- Hip Implant Complaints Surge, Even as the Dangers Are Studied (earlsview.com)
- Hip Implant Complaints Surge, Even as the Dangers Are Studied (nytimes.com)
- Reuters-INSIGHT-DePuy’s handling of hip recall sparks questions (earlsview.com)
- UK – Answers to commonly asked questions from patients with metal-on-metal hip replacements / resurfacings (earlsview.com)
- Barry Meier – Study Faults Approval Process for Medical Devices (earlsview.com)
- ‘Metal on metal’ hip implants leave some recipients in pain, at risk (earlsview.com)
- Medical Devices – Balancing Regulation and Innovation (earlsview.com)
Howard Sadwin said:
Ann, is absolutely right the FDA is a bad joke being directed by the medical device world.any of their new innovative new rules,regulations, etc. appear to add more patch work to an old leaking roof. There appears to be more concern on adding more groups to watch over these new groups and more groups to make sure the other groups no where to go to work on these new ideas. Old roofs need to be replaced,not constantly repaired, if you don’t replace the roof, chances are you will have mold issues. The FDA is beyond mold issues. Get rid of the way too many groups, make discloure laws that tough, impose stiff fines, maybe even shelf products, or take a doctors hospital rights taken away. Break the law, you pay. Modify a data system, device already has an ID #, so patients with these devices can be tracted when they have follow-up visits with doctors .This information goes into a data system developed and paid for by the medical device manufacturers, controlled by the government. More common sense,logic less B.S.
Where is the concern for me,Ann others who are suffering due to inadequacy in this system.
Where is the research data these manufacturers were to disclose addressing these issues? It appears there is more research on having new devices approved rather than taking care of existing issues.
Does the FDA think we are not going to read through these shenanigans? I would like one of the decision makers of medical devices explain to all of us what they are doing, and do they even no.
They need to listen and see Ann, me and others so they can hear our thoughts and they can ask face to face how it feels to lose the quality of our lives.
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