Device use expands through adaptation, innovation

The Mayo Clinic's Dr. Richard Marsh helps control brain seizures in epileptic patients with a fiber-optic laser first introduced to treat prostate tumors.

At the University of Minnesota, Dr. Ganesh Raveendran has figured out how to treat young stroke victims with a device designed for congenital heart defects.

It doesn't matter whether the medical devices' inventors, or the regulators who approved the products, ever considered such methods.

"It is common practice in the cardiology world," said Raveendran, director of the U's cardiac catheterization laboratory. "We expand the scope."

Doctors have complete discretion to use medical devices in any way they think helps their patients — including "off-label" uses that were never envisioned. These adaptations are expanding the use of medical devices among U.S. patients of all ages.

But the flexibility this system enables comes with risks for patients.

The same kind of experimentation that transformed a prostate product into a promising brain probe led to the flawed use of surgical mesh as a treatment for women's incontinence, injuring thousands.

"Frankly, the oversight is really quite relaxed and not accountable to the public," said Lisa McGiffert, director of the Consumers Union Safe Patient Project.

The Food and Drug Administration reviews the safety and effectiveness of devices and how they can be sold. In recent years, criticism of the FDA has intensified, as device companies accuse the agency of stifling business and innovation through unnecessary review protocols. Consumer advocates argue the opposite, claiming the FDA fails to demand adequate product testing.

But the FDA's oversight extends only to device makers, not doctors.

IT IS NOT OUR PLACE TO say, 'Here is how you should treat that patient,' " said Christy Foreman, who directs evaluations at the FDA's Center for Devices and Radiological Health.

The only way the FDA gets involved with the off-label use of a device is when a medical technology company seeks the agency's approval for a popular adaptation to increase its sales. However, the typical process requires only that companies demonstrate that a new device is similar to an existing product, which means little human testing.

Often, device adaptations occur when doctors simply have no other options, or they are searching for a less-invasive treatment. The decision to adapt is never "cavalier," said Marsh, a neurosurgeon.

At Nascent Surgical in Eden Prairie, Dr. Leonard Schultz is helping turn a surgical smoke control device into a product that can be used to reduce postoperative infections.

Schultz says he understands the concerns as devices are used in new ways, but there's no such thing as risk-free medicine.

"Progress will never be done without risk," Schultz said. "Every time technology changes, there is a chance that someone is going to get hurt."

The (almost) bionic woman

SYLVIA GONZALEZ OF Fresno, Calif., says she has so much metal in her body she should see a mechanic instead of a physician.

Stricken with juvenile rheumatoid arthritis and an autoimmune disease, the second-grade teacher needed to have a metal rod implanted in her thigh when she was 9 years old.

By the time she reached 21, Gonzalez had artificial hips and knees. Since then, she has received a steel neck bracket, artificial ankle, shoulder and partial pelvis.

If she had been born 30 years earlier, she would have been bedridden and died young.

She says she owes her quality of life to her doctors' willingness to improvise and adapt medical hardware.

"My parents were told that I would never walk," Gonzalez said. "The fact that I have worked for 20 years is a testament to these joints."

Now 49, Gonzalez remains active and independent.

But she has already begun replacing artificial parts in her body through increasingly complex surgeries that involve painful rehabilitations. She faces a third round of replacements when she reaches her 70s.

"It's like a ticking time bomb," Gonzalez said. "You're happy to have the joints, but you know they're going to wear out."

The kinds of adaptations Gonzalez needed decades ago are still being made for today's youngsters. Doctors find themselves with no other choice than to turn to a device that isn't designed for a particular patient or ailment.

During a recent operation, Amy McIntosh, a pediatric orthopedist at the Mayo Clinic, inserted several steel screws into the deformed spine of a 5-year-old patient. But not before she had to cut them shorter.

"Maybe 25 to 30 percent of the time I end up taking something that was not specifically made for a kid and figuring out a way to make it work," said McIntosh.

Congenital scoliosis forced JunFen Freihammer's spine to curve 108 degrees, bending the little girl's body almost in half.

With no spinal devices specifically made for children, McIntosh had to improvise. After 12 operations, the curve of JunFen's spine has been reduced to 30 degrees. She walks upright, goes to school and plays with her dog, Daisy, in her yard in Roseville.

"It has literally allowed her to hold her chin up high," JunFen's mom, Karin Freihammer, said. "It was something we never thought possible. It's made a difference socially, emotionally and spiritually."

Close is good enough

MANY PRODUCTS developed from popular off-label uses of other established devices end up before the FDA. About 90 percent of new FDA-cleared devices get approved simply because they perform similarly to products already for sale.

"The standards for clearing these devices are much lower than for drugs," said Dr. Michael Carome, the medical research director at the consumer advocacy group Public Citizen.

Comparison to similar devices is much faster than clinical trials.

It is only supposed to apply to devices that are not lifesaving, life-sustaining or potentially dangerous. But the comparison system has produced enough harmful devices that in 2011, the Institute of Medicine recommended scrapping the process because of inadequate testing. The device industry successfully lobbied Congress not to do so.

"The basic structure of the process is sound, has served patients well for more than 30 years and helps facilitate medical innovation," said Janet Trunzo, senior executive vice president of technology and regulatory affairs at the Advanced Medical Technology Association.

Current law requires the FDA to approve moderate-risk medical devices similar to products already on the market — even if those products eventually failed and manufacturers had to recall them.

The device industry successfully blocked consumer groups' calls to change that practice.

"No company intentionally places an unsafe medical device on the market," Trunzo said. The FDA has said that "the number of cases where a manufacturer relies on a faulty predicate is extremely rare."

Dr. Jeffrey Shuren, who runs the FDA's Center for Devices and Radiological Health, told a 2012 congressional hearing that it happens "in a few cases." The agency cannot say exactly how many new devices it has cleared for sale based on their similarity to previously approved products that were determined to have problems.

"We don't have this figure," a spokeswoman said, because the agency has "no way to track it."

The nightmare outcome

AS FAR AS LANA KEE-ton is concerned, doctors implanted her with an untested, unsafe medical product. As proof, she offers a photo of an ugly scar that stretches below her navel, the result of multiple operations.

The Miami Beach steel broker was 54 in December 2001 when doctors surgically implanted her with polypropylene hernia mesh to treat her for urinary incontinence. The mesh had evolved through off-label uses of similar mesh products approved by the FDA.

A dozen years later Keeton is still in pain.

Several medical device companies developed specific "vaginal mesh" products and got the FDA to allow their sale because they were similar to products already on the market. The number of postoperative hospitalizations for complications from vaginal mesh implants more than doubled from 5,448 in 1993 to 12,096 in 2010, the Star Tribune found.

"It's a horror no one should have to go through," said Keeton, who has testified before congressional committees about the lack of scrutiny in medical device development.

Minneapolis attorney Yvonne Flaherty, who represents numerous mesh victims, said many of the mesh products used by her clients were based on a previous version of vaginal mesh that was recalled in 1999.

"Many of these women didn't realize that the products being put in them were never tested," said Flaherty, who works at the Lockridge Grindal Nauen law firm.

The FDA's advisory committee has recommended that vaginal mesh be reclassified as a potentially dangerous device, requiring clinical trials before going to market. But the agency has not yet changed the classification, saying it needs more data.

Despite vaginal mesh's myriad problems, regulators followed the rules when the products were approved, said the FDA's Foreman. They were, after all, similar to other products on the market.

"We look at the product and if it is equivalent, it is equivalent," Foreman said. "We by law are bound to clear [them]."

Star Tribune staff writer Glenn Howatt contributed to this report. Jim Spencer • 202-383-6123