At his home in Plymouth, Minnesota, Peter Quimby must waterproof the batteries and control unit that run his left ventricular assist device, LVAD before he showers July 10. He is on a waiting list for a heart transplant.
Jay Alva's sneakers pounded the treadmill, set to the speed of a brisk walk. Sweat dripped off the 53-year-old as he hit a groove during a recent workout.
For almost two decades, the youth soccer and football coach from Eagan, Minn., moved like a man who needed a walker. A degenerative hip condition kept Alva from running with his players or even things like tying his shoes.
Brushing off a doctor's advice that he was "too young," Alva got artificial hips four years ago. Now pain-free, he moves with the energy of a man in his 30s, amused at the notion that he wasn't old enough for such treatment.
"I am living so much better now in my 50s than I did in my 40s," Alva said.
Hundreds of thousands of Americans are receiving medical devices that were once considered nearly exclusive to the elderly. The shift is profoundly changing patient care and expanding the fortunes of the medical-technology industry while amplifying concerns over the safety and oversight of some products.
The movement is so dramatic, the futures of major medical device companies such as Medtronic, St. Jude Medical and Boston Scientific are increasingly tied to younger groups and the new markets they represent.
Middle-age Americans, in particular, are driving this trend as they seek ways to remain physically active. The number of patients ages 45 to 64 who had a hip replacement more than doubled from 2000 to 2010, according to a Star Tribune analysis of data from the U.S. Department of Health and Human Services. The increase was more pronounced for knee replacements, rising 213 percent.
"This is huge," said Dr. Robert Hauser, a cardiologist at the Minneapolis Heart Institute who has studied the safety and effectiveness of heart devices for years. "I think it's a tremendous step forward, but there are issues that need to be dealt with."
Though widely celebrated, some treatments have been shadowed by reports of devices or other medical products faltering -- defective wires in defibrillators, failing artificial hips and leaky drug pumps, among them. Patients have suffered complications, severe pain and even death. Every year, 25 to 40 medical devices are recalled for high risk -- meaning a patient's life could be in jeopardy.
Device companies are facing thousands of patient lawsuits challenging the safety of some devices, and federal regulators are under greater pressure to intensify their oversight. At the same time, device makers are spending millions to promote their products to doctors and patients while simultaneously pushing to simplify governmental reviews to quicken their products' path to market.
Doctors and device makers are converting technology to regulate heart rhythms or treat diabetes into new tools for a wider range of ailments, including overactive bladders, anxiety and migraines. The result is a wider range of devices and other medical products being implanted or connected to more nonelderly patients.
But this growing use of medical hardware should be tempered by a call for safety, public disclosure and caution, consumer advocates say.
"We're not talking about computers or cars or toasters," said Lisa McGiffert, director of the Consumers Union's Safe Patient Project, a group that campaigns for better medical practices. "We're talking about things that go inside people's bodies."
Boom in orthopedics
No area of medicine is seeing more nonelderly patients turn to medical devices than orthopedics.
In 2000, one-third of the estimated 157,000 Americans who had hip or knee replacements were younger than 65. Ten years later, the number had nearly tripled to 430,000, meaning almost half of those procedures were performed on these younger patients.
Two contradicting forces are pushing patients toward artificial joints. The rising rate of obesity has led to more cases of deteriorating hips and knees from excess weight. Yet, more Americans are playing sports or exercising in their 30s, 40s and 50s, putting more wear and tear on their joints.
To get active again -- and quickly -- patients are more willing to consider joint replacement at a younger age than they were a decade ago, said Dr. Daniel Berry, chairman of orthopedic surgery at the Mayo Clinic in Rochester, Minn.
"We're seeing higher demand," Berry said of younger patients who want a new hip. "And they are going to use it a lot harder than somebody who is older."
Patients who get a device at a younger age usually must replace it more often. Each replacement means an expensive surgery, possible complications and significant rehabilitation.
Most artificial hips have a life span of 15 to 20 years, depending on how much patients weigh and how hard they push their bodies. Some companies developed a hip that used all-metal components in the belief it would improve durability. It didn't necessarily turn out that way.
Terri Wagner-Morley of St. Paul, Minn., had what is commonly referred to as a metal-on-metal hip, produced by DePuy Orthopedics Inc., implanted in 2008. Within two years, the hip began "popping." Soon, the pop turned to pain.
Wagner-Morley had the hip removed, but infection prevented doctors from putting in a new one. Plastic "spacers" were implanted instead, and she was bedridden. Last summer, she had a metal and ceramic hip implanted, but a stress fracture during rehabilitation has left the 55-year-old woman limping and angry. She remains disabled and without a job.
"I have had four surgeries now," she said. "As I get older, I'm probably going to be wheelchair bound. I might have a positive view, but really, I'm pissed off."
It remains somewhat unclear whether corporate marketing is driving the expanded use of medical devices. Certainly, more doctors are willing to consider them before other options have been exhausted.
In many cases, doctors remain hesitant because they don't know how long a device will last and under what conditions, said Joseph Galatowitsch, president of Dymedex, a consulting firm that works with medical technology companies.
"The tension is that clinicians want to use these technologies in younger patients," Galatowitsch said. "But they feel frustrated because they feel forced into weighing the risk versus the benefit."