Feb. 26, 2001 (Washington) -- When 63-year-old Estelle Knowland got a Sulzer Orthopedics hip implant last March, she thought it would end 20 years of disabling arthritis. "My expectation was that following a period of recovery, I would be fine. I would be pain-free," Knowland tells WebMD.
However, the San Francisco-area resident was shocked when she got a call from her surgeon in December telling her the bad news -- some 17,000 of the devices were being recalled nationwide because of a manufacturing flaw. Specifically, an oily residue on the upper part of the implant, where the cup fits into the ball, could cause the prosthesis to loosen.
While Sulzer officials say the company "deeply regrets any effect this may have on patients," a number will have to have the implants removed. H.M. Reynolds, MD, the Oakland, Calif., orthopaedic surgeon who put in Knowland's device, estimates he'll have to replace 80 of the 250 Sulzer artificial hips he's implanted, according to his research assistant Jacob Keeperman, BS.
It's not clear yet whether Knowland will need a replacement, but her bone hasn't grown into the device as anticipated. She needs drugs to keep the pain in check, and those cause an allergic reaction.
Even though the company promises to pay all uncovered out-of-pocket costs for additional surgery, Knowland is dreading another trip to the operating room to remove a device she thought would last 30 years -- essentially, the rest of her life.
"Postsurgery, the first few days are monstrous," she says.
Ironically, Knowland says that while she was warned about the various risks of surgery -- including reactions to anesthesia, blood clots, and pain -- the doctor said virtually nothing about possible pitfalls of the implant.
Knowland's situation is not unique, according to a blue-ribbon panel that prepared a report last year on medical device performance for the National Institutes of Health (NIH).
"We heard from enough people to convince me that there are an awful lot of folks out there who aren't getting the kind of information that they need -- not just to decide whether or not to have the procedure, but to really know how to deal with it after they've had it," says Edward Brandt Jr., MD, PhD, panel chair and director of the Center for Health Policy at the University of Oklahoma Health Sciences Center in Oklahoma City.
According to a spokesperson for the Food and Drug Administration (FDA), about 1,000 medical devices are recalled annually. Many of the problems are minor, but some, like defective pacemaker leads, can be life threatening.
The public seems to have a different view of devices than they do of drugs, Brandt says, and believes that a drug or drug interaction is more likely to cause problems than a device would be. "I just don't think they think enough about the possibilities of similar things happening with devices," Brandt says.
A major issue, according to the NIH report, is that the FDA doesn't generally require makers to report problems in retrieved devices as a condition for approval. "If reported to the FDA, manufacturers may fear that proprietary retrieval information may be disclosed," the report states.
However, Jim Benson, who heads the industry lobby group AdvaMed, says both new and existing devices are scrutinized without bias in a rigorous approval process. Furthermore, it's not possible to study as many patients using a device as taking a drug, he tells WebMD.
Doctors need to do a better job of passing on the pluses and minuses of devices to their patients, Benson says, and patients themselves can check out information on the Internet. "It might take a change in law to require manufacturers to directly inform patients ... and that would probably do more damage than good, because it would diminish the physician's role," Benson says.
Another possibility, Brandt says, is that the NIH and the FDA could work more closely together to develop safer and better devices.