How the FDA allows faulty, and sometimes dangerous, medical devices onto the market
As a busy urologist in Madison, Wis., Michael Kuglitsch saw firsthand the pain and suffering of the more than 10 million American women afflicted with incontinence. The condition was more than embarrassing; it was debilitating. So Kuglitsch was intrigued when a salesman from Boston Scientific Corp. came by with a new product back in 1997 that promised to make corrective surgery less painful and more effective. The ProteGen Sling, a synthetic material designed to support the bladder, had just been approved by the Food and Drug Administration. And if the salesman was to be believed, it worked like a charm.
Kuglitsch began implanting the device in patients. But many soon developed problems. Instead of returning to their normal lives, as expected, most of the patients began to experience extreme discomfort and infection around their implants. Three lost all their hair and fingernails, Kuglitsch said. Later investigation revealed that many of the devices were wearing through patients' vaginal or urethral walls. "It finally reached the point," Kuglitsch said, "where I was removing them every week."
What Kuglitsch didn't know, until the product was pulled from the market and the first of some 600 lawsuits was filed, was that Boston Scientific had received more than 100 similar complaints by the time he stopped implanting the device in September 1998. Internal company documents show that the manufacturer didn't tell the FDA about nearly 400 more. More shocking to Kuglitsch was that the FDA had approved the sling for incontinence surgery without requiring any new testing. In fact, the sling, like 98 percent of the 80,000 medical devices on the market today, was approved through a streamlined process that requires data to show only that a product is similar to one already in use.
Big business. Today, 1 in 10 Americans is walking around with some kind of synthetic body part. Pacemakers, defibrillators, heart valves, knee joints, and spinal-fusion screws help make the lives of many of these people less painful and more livable. They have also created a big business. Industrywide, revenues top $78 billion a year. Unsurprisingly, lots of upstart companies want a piece of the pie. In just the past five years, the number of manufacturers of medical devices has risen from just over 9,000 to more than 13,000. An aging population and new technologies are expected to fuel substantial growth for some time to come.
Amazing as these devices are, many of them have caused chronic pain and crippled patients. In rare cases, they have killed people. There are few hard statistics, but from 1990 to 1999, according to the independent medical research organization ECRI, the number of recalls of implantable devices has nearly tripled, from 35 to 104 a year, with a single recall sometimes affecting thousands of patients. The problem, critics say, is an FDA approval process that allows faulty devices to be marketed before they have been properly tested and the agency's inability to adequately monitor devices once they are in use. "If we keep this up," says Arthur Kaplan, chairman of the Department of Medical Ethics at the University of Pennsylvania, "we will end up with a device that slips through and takes a lot of lives."