Problems with Medical Devices Highlighted by CBS Sunday Morning
If you were watching the morning news programs on Sunday, you may have caught a report on CBS that brings some much needed attention to the problems with the FDA’s 510(k) fast-track approval process and the large number of faulty medical devices that have been implanted in patients without being rigorously tested and researched, including metal-on-metal hip replacements and other devices.
▸ CBS Sunday Morning: When Medical Implants Fail
The report on CBS Sunday Morning highlighted concerns raised by doctors, the Government Accountability Office and other experts who have indicated that the FDA fast-track approval process and medical device oversight is fundamentally flawed. As a result, a number of medical devices have been allowed onto the market as “substantial equivalents” to other approved devices, only to determine years after being on the market that they contain serious design defects.
One of the examples cited in the report are the recent problems with metal hip implants, which were approved by the FDA based on devices already on the market. Therefore, they did not have to undergo the detailed testing and research most consumers expect for medical devices.
After an estimated 500,000 people received a metal-on-metal hip implant, evidence has now emerged about serious health problems from metallosis or metal toxicity, which could occur as metal particles are released from the metal parts rubbing against each other over time.
In August 2010, a DePuy ASR hip recall was issued after more than 90,000 of the implants were sold. It was discovered that the DePuy ASR implant has a failure rate of 12% to 13% within five years after surgery, requiring individuals to undergo risky revision surgery.
The ASR implant was approved as a “substantial equivalent” of the DePuy Pinnacle metal-on-metal hip, which was itself approved under the FDA’s 510k process and has also now been associated with a higher-than-expected failure rate.
It was not until hudnreds of thousands of people had the metal-on-metal hips implanted into their body that the FDA began to investigate the design of the device.
The agency relies on a system where problems are reviewed after they are identified on the market, allowing consumers to serve as unknowing study subjects for untested devices. In addition, the FDA is often slow to recognize potential problems and manufacturers have substantial incentive to delay any action, allowing them to continue to sell potentially defective devices.
2 Comments • Add Your Comments
Susan says:
I had a Zimmer total hip replacement Implant on January 9, 2012 and I am so worried now since this report and found out that this device fails and could poison me!
Posted on April 14, 2012 at 1:31 am
Geoff says:
I had a hip replacement some 8 years ago, 3 years ago I developed an infection in this area and spent time in hospital having the problem fixed.
Recently i noticed my leg becoming sore and over two months it got to the stage that i need a stick to walk at all. Most of the time Ican only rest in my recliner as it is to painfull to moov around. I have a duragesic Patch and use 8 plus Panamax per day.
I have been back to my Orthopedic Surgon had all of the tests done for infections and xrays but nothing can be found.
I have lost a lot of weight, am off my food, I have noticed that quite often my Testies and scrotum can be enlarged and hot, I have trouble controling my body temp, any slight change and I am either to hot or to cold.
Has anybody elese had these problems
Posted on November 5, 2012 at 7:42 am