Better late than never?
The U.S. Food and Drug Administration (FDA) will hold a gathering of scientific and clinical experts to discuss whether metal-on-metal (MoM) artificial hip systems should undergo more rigorous scientific scrutiny before they are implanted in U.S. patients, which sounds infinitely reasonable.
On Thursday, March 29, the FDA announced the meeting will be held June 27-28. Although the meeting site is to be determined, anyone interested should contactAvena.firstname.lastname@example.org or .
The expert panel will discuss the available scientific data on metal hip implants regardless of whether it’s the total hip replacement or a resurfacing procedure, and whether they should be subjected to the same sort of premarket scrutiny for safety and efficacy as drugs.
Unlike pharmaceuticals, medical device makers enjoy a hands-off approach to regulation. Complications that arise in an undetermined number of patients are investigated after they’ve done their damage. I continue to believe if the public understood the Wild West approach the FDA takes to some of these dangerous devices, there would be outrage. Those who draw the short straw and experience complications understand what’s happening after the fact.
Howard Sadwin is one of those people. Our client, Sadwin, 65, of Sarasota, Florida, received the Birmingham Hip Resurfacing System (BHR) made by Smith and Nephew in 2007. The company says resurfacing is a bone conserving procedure that is ideal for the active patient. Howard was very active, training his Labrador retrievers, hunting, and playing with a young grandson. Now he is in a wheelchair. By 2010, his MoM hip had dislocated three times and had to be removed. The surgeons found so much infection and fluid in his body that they told Mr. Sadwin that he was dying. He spent 10 months in the hospital with doctors cutting out infection and a portion of his femur. He went 16 months with no right hip at all.
A recent BBC/ British Medical Journalinvestigation looked into Smith & Nephew as well as Johnson & Johnson and Zimmer Holdings, all manufacturers of MoM hips, and found some patients develop an immune and inflammatory response to metal hips which is likely related to debris from the metal ions which leach into the bloodstream.Preview
About 500,000 patients in the U.S. have all-metal hips but we don’t know the complication rate, because unlike the UK, we don’t monitor such things here. You have a better chance of receiving a notice about your recalled defective Toyota than your hip implant.
It’s a crazy, mixed-up system that is putting countless patients at risk.
Back to the FDA. The purpose of the meeting is to get practitioner input on metal-on-metal total hip replacement systems as well as the metal-on-metal resurfacing systems.
To be considered:
- Failure rate and modes
- Metal ion testing
- Imagine methods
- Local and systemic complications
- Patient risk factors
- And consideration for follow-up post surgery
I hope those in attendance are ready to listen to Howard who would love to share his tragic story with the panelists leaving no doubt that this was a preventable outcome if the FDA had been doing its job as responsible and hands-on regulators. Howard has also been in touch through his blog and internet research with patients from around the world who have similar tales of pain and suffering attributable to metal-on-metal implants.