When our clients discover that their metal-on-metal (MoM) hip has failed and never went through U.S. Food and Drug Administration (FDA) approval for safety and efficacy, they ask – how did that happen?
Most Americans do not understand that medical devices are largely unregulated, even for those devices that are intended to be permanently implanted in the body. The FDA just does not have the personnel or the funding to oversee medical devices the way it does drugs.
This month in the New England Journal of Medicine a Perspective piece “The 510(k) Ancestry of a Metal-on-Metal Hip Implant,” lays out exactly what happened.
The Medical Device Amendments of 1976 determined that medical devices fell into one of three classes – Class I for low-risk devices such as band aids and toothbrushes; Class II for moderate-risk devices such as an infusion pump; and Class III was reserved for high-risk devices and some that never were classified such as metal-on-metal hips.
The classes don’t always represent the level of risk. For example, transvaginal mesh is considered Class II even though it is a permanent implant.
For the low or moderate risk devices it would be adequate to name a “substantial equivalent” device that was already being sold. That is the 510(k) notification process for FDA approval. The device maker essentially notifies the regulatory agency it plans to market a device and with an exchange of paperwork names a “predicate” even though that predicate may never have undergone any stringent reviews for safety.
Class III devices, those high-risk were supposed to undergo a more careful review requiring clinical trials such as what drugs undergo. That’s called the premarket approval (PMA).
MoM hips fall into a sort of limbo.
Although Class III, they are allowed to be approved under 510(k). They were supposed to be reclassified by December 31, 2012 however the watchdog agency failed to meet its deadline. Nineteen Class III devices including MoM hips can still be marketed through a 510(k) clearance.
“Because many predicates have never been assessed for safety and effectiveness, an FDA finding of substantial equivalence does not mean that a new device is safe and effective; it means only that the device is deemed no less safe and no less effective than a predicate,” said Brenda Fulmer, a Partner at Searcy Denney who oversees MoM cases at the firm.
Consider this – even a device that has been recalled can serve as a predicate! That is something most people would find astonishing and unacceptable. It’s not what we expect of taxpayer supported regulatory agencies.
The DePuy ASR XL Acetabular Cup System- a MoM hip implant received 510(k) clearance in June 2008. There were no clinical studies required even though the elements that made up the MoM hip were never before used together.
The 510(k) process does not take into consideration new devices, new design, new materials, and new technology. The ASR has a porous bone in-growth surface, metal-on-metal components, and a large femoral head that was novel. The researchers say none of the predicates named had the same combination of characteristics.
Looking forward, the authors say the recently passed Medical Device User Fee and Modernization Act should make it easier to reclassify those 19 devices still in limbo by either requiring a more stringent PMA review or reclassify them as Class II.
Thanks for your update, however even if a device goes through the “extensive” requirements ” of the FDA that doesn’t necessarily mean the device is safe.
Perfect example of this: Smith & Nephew’s Birmingham Hip Resurfacing Device (BHR) a metal on metal hip device. This device was an innovator a FIRST for hip resurfacing in the USA. HOWEVER the device was from a foreign country, all the data, tests, reports came from the word of a single surgeon.
This surgeon had his own controlled patient group who supplied data for the approval. The FDA panel that approved this device September 8,2005 raised enough concerns and questions that I still don’t understand how it was approved- PERHAPS
CORRUPTION ?? Today there is more and more evidence that this metal on metal device is and has hurt many patients. This company knew there was the risk of problems should metal particles from the device into the human blood. What they didn’t disclose is the very nature of this debacle- they perhaps withheld information or didn’t have the data because their testing didn’t properly go out that far in time yet.
Because the device has a PMA tag it is protected by the pre-emption laws. In other
words Smith & Nephew’s BHR hurt me and there is little I can do about it today.
The pre-emption laws on medical devices can harbor a criminal.
Seems like a conflict of interest DOESN’T IT ?? On one hand the FDA is to protect and ensure the safety and quality of my life and on the other side of the coin the FDA protects the manufacturer or Market Share or Rate of Return to the investors.
If you have a chance read the testimonies taken from the hearings on the Medical
Device Safety Act of 2009 & 2011 ( H.R. 1346 )
The FDA is labeled as not having the means to properly verify information including pertinent data that was used in the PMA approval of a device. The FDA often relies on what they are told. It appears to be a standing joke (a bad one at best)that data, information, reports are pushed through for approvals and some of these devices were never tested.
The FDA, who can’t seem to control its own functions rules and controls the pre-emption laws involving PMA approved devices.
Take a moment go to You Tube type Howard Sadwin and watch what Smith & Nephew’s
BHR is responsible for, and then see what you think knowing this device is protected through pre-emption law.
Respectfully
Howard Sadwin (hbs924@verizon.net)
PS to my comments I forgot the inventor received 99 million pounds for the BHR from Smith & Nephew — of the 99 million pounds 33 million pounds was paid to the inventor by Smith & Nephew once the Birmingham Hip Resurfacing Device received the PMA approval from the FDA.
ISN’T THIS A CONFLICT OF INTEREST ???
HOW DID THIS DVICE SLIP UNDER THE WIRES ??
Whenever you use the hip (for example, by going for a run), a cushion of cartilage helps prevent friction as the hip bone moves in its socket. Despite its durability, the hip joint isn’t indestructible. With age and use, the cartilage can wear down or become damaged. Muscles and tendons in the hip can get overused. The hip bone itself can be fractured during a fall or other injury. Any of these conditions can lead to hip pain.