25 million Americans are living with implanted medical devices, from pacemakers to artificial joints. Up to 25 million Americans are living with implanted medical devices, from pacemakers to artificial joints, but too many patients have unrealistic expectations of how long implants will last and don’t even know what model is in their bodies, a scientific panel said Wednesday.
Also, scientists are hampered in efforts to create better medical implants because too few of the devices are removed from patients’ bodies – when they die or need a replacement – to study which lasted longest, worked best and was safest, said experts convened by the National Institutes of Health.
One big reason: Fear of lawsuits if scientists point out a flaw to correct.
But that lack of research means doctors today have few ways to compare different implants and choose the best model – and in turn are providing their patients with too little information, leading to unrealistic expectations, the panel said.
Even the panel’s co-chair ran into the problem when she had hip replacement surgery last August.
The surgeon held up her X-rays, “and said, ‘Two new hips.’ That’s all I was going to learn about it if I had not come with all sorts of questions,” said Northwestern University engineer Julia Weertman.
fund better education of patients and doctors, including establishing an Internet site with the latest information
So the panel called on the government Wednesday to fund better education of patients and doctors, including establishing an Internet site with the latest information comparing different implants’ risks and benefits. The idea is if a patient needed, say, a new hip, he or she would have a source of reliable information on what is state-of-the-art and how long to expect the joint to last given the patient’s age and other factors.
Also, doctors should more thoroughly inform patients before surgery of the short- and long-term risks of their implant, the panel stressed.
Perhaps of most immediate importance, the panel also recommended each implant recipient be given a card to keep that lists the make, model and serial number of their implant – important in case of a recall or questions about a device’s safety, but information most patients today never get.
Such steps also could persuade patients of the need to let scientists retrieve and study their implants upon their death or, in the worst-case scenario, a device failure.
Actually, most medical implants work well, the panel stressed – many last years, even decades.
But patients “never seem to think a mechanical (medical) device is ever going to wear out, even though … they have enough experience with their automobiles,” Weertman said. “We are trying to educate the consumer so he will realize things don’t last forever, and there is a need to improve these devices.”
the NIH panel acknowledged it faced complex hurdles
Still, the NIH panel acknowledged it faced complex hurdles. The panel declined to recommend a national database to track implant patients, as some other countries do, because of confidentiality concerns and cost. Nor could the panel estimate how much consumer education and the hoped-for Web site would cost, or even who would ensure patients received those implant information cards.
Also, some manufacturers do manage to retrieve and study certain implants, but typically consider their findings a trade secret, so doctors don’t learn of product concerns.
“I would like to draw attention to what I believe is a code of silence I believe is imposed … by the threat of litigation,” complained panel member Arthur Kantrowitz, a Dartmouth College engineer.
The panel, however, urged NIH to hold another meeting of legal experts hunt a solution.
But some manufacturers do publish their studies of retrieved implants, and would provide information if the government starts an implant Web site, said Jim Benson of the Health Industry Manufacturers Association.