In the months leading up to Linda Baez's third open-heart surgery, she spent most of her days at home. Breathing was no longer easy for her; neither were simple tasks like climbing stairs. The 44-year-old mother of four constantly felt weak and exhausted. But, above all, recounts her attorney, she was worried. Two operations to replace her leaky heart valve had already failed, and even though her doctors were implanting a different artificial valve this time around, she knew that there was a good chance that she would not make it.
And she didn't. The Dedham, Mass., resident passed away quietly in her sleep one June night last year, just a few weeks after her operation.
At the time of her death, Baez had a personal injury lawsuit pending against the manufacturer of the valves, St. Jude Medical Inc., for all the pain and suffering she said she had endured due to having defective valves implanted in her not once, but twice. The whole reason she had the surgery in the first place was to correct her mitral valve prolapse, a heart condition she had had since she was a teenager. Her valve had deteriorated to the point where it was leaking blood back to the chamber from which it was just pumped. But her family believes all she received were more leaky valves. In fact, St. Jude had issued a recall of its product, the Silzone heart valve, in January 2000 because it had a higher incidence of leaking around the sewing cuff fabric (which is used to attach the device to the heart tissue) than its predecessor. Approximately 36,000 patients worldwide had received the product, 12,000 of them in the United States.
The exact cause of Baez's death will not be known until the official pathology report comes out. But Bruce Finzen, a Minneapolis attorney who is now representing the Baez estate in a wrongful death suit against St. Jude, says all evidence points to the manufacturer. "Her family holds the manufacturer responsible for her death," he says. "Her surgeon and cardiologist believe the trauma of three open-heart surgeries in a year was a substantial factor in causing her death."
What happened to Baez is a horrifying example of what can -- and, increasingly, will -- go wrong in an era in which it's become normal to trade in your own defective body parts for those manufactured, assembled and sorted by machines. In this brave new world of medical technology, surgeons can place a computerized defibrillator next to your heart, ready to shock your ticker back into action should it falter. Countless lives are saved, or prolonged, each year because of inventions like this. And as new, improved body parts come rolling off the medical assembly line, it becomes easy to take them for granted: Only a scar seems to separate the mechanically altered from the rest of us.
That is, until there's a glitch. As with anything mass-produced, not every batch is perfect. Flawed implants are rare, but sometimes they make it all the way from the factory to the surgeon's table to a carved-out place inside of you. And unlike a station wagon, which can have a faulty transmission replaced in an afternoon at the garage, the only way to retrieve a defective implant, in many cases, is to cut open a human body. And since there are no guidelines on how to proceed when there's an implant recall, whether a surgeon removes, or "ex-plants," the device is largely a judgment call.
Since 1977, there have been 571 recalls of implants, according to ECRI, a nonprofit company that assesses medical devices and tracks the number of Food and Drug Administration-reported recalls. In 1999, there were 91 reports of recalls; in 2000, 55. (In 1985, when far fewer implants were in existence, there were only 10.) In many cases, each recall involved thousands of units of the particular product. (This figure does not correspond to the number of people who received the device or had to have it taken out.)
"If you don't have implants, people will die or be crippled," says Dr. Joel J. Nobel, president of ECRI. "If the question is, are some of these implants going to become defective over time, the answer is yes. That's reality."
Implants used in almost every part of the body have been recalled, from lifesaving devices like pacemakers to neuromuscular stimulators (used for pain remediation) to hip replacement devices to penis enlargement implants (one lot leaked hydraulic fluid) and implants used for breast enhancement (one company sent out unsterile implants). Although the FDA has the authority to order a recall for a product that is believed to threaten public health, it rarely comes to that. Most of the time, once a problem is documented, the recall is voluntarily made by the manufacturer. The company reports the problem to the FDA and then writes a letter to physicians detailing the severity of the problem. A product can be recalled not only for having bad wiring but also if it's just incorrectly labeled.
"There are no guidelines that the FDA puts out," says FDA spokeswoman Sharon Snider. "It really is up to the doctor who's monitoring this individual patient to make those types of decisions because the patients' conditions vary and not every single device is necessarily faulty."
But for those who find themselves part of a manufacturer's margin of error, with the wrong serial number implanted under their skin, the dilemma of what to do can be excruciating. The decision to ex-plant is a high-stakes gamble: Take it out and risk the complications of surgery and the possibility that the second procedure won't be as effective, or leave it in and hope it's not a time bomb waiting to go off.
Physicians say that as modern medicine progresses, we will be seeing more and more cases of patients living with faulty devices inside them, and the medical community will increasingly face the question of what to do each time a recall is announced. For example, the success of a hip replacement surgery depends on the quality of the bone that supports the prosthesis. And that quality can be greatly diminished by a second surgery.
Patients don't decide whether to have the recalled implant removed; doctors do. Snider says most doctors, armed with the knowledge that only a small percentage of the recalled implants will actually fail, choose to leave them in. Still, the decision varies widely from patient to patient, largely depending on the person's age, physical condition and whether there are clear signs -- like those that Baez reportedly experienced prior to her final surgery -- that the device is not working.
"Let's say [problems] occur in 20 percent of people who have the implant," says Dr. Joseph Zuckerman, chairman of New York University's Hospital for Joint Diseases' department of orthopedic surgery. "But look at the other side -- 80 percent aren't having problems. Why redo something that is going to be successful?" Zuckerman also adds that because FDA oversight is so effective, it rarely happens. In fact, after all his years as a surgeon, he has never had a product he's implanted recalled.
But critics of the medical devices' manufacturers contend that defective parts are making it past the normal screening process because companies are rushing their products to market without appropriate testing. (They also find it disturbing that most studies are funded and conducted by manufacturers.) They also charge that the companies are caving in to competitive pressures to "improve" devices that already had been proven to work over time in an effort to win new customers.
For example, the Silzone heart valve's predecessor, the St. Jude artificial heart valve, was one of the most popular such devices for the past two decades and had very few complications. The main difference between the old St. Jude model and the new Silzone was the addition of silver around the sewing cuff fabric: The metal was supposed to reduce infection.
According to the FDA, the Silzone was approved as a supplement to its basic product in 1998. The FDA reviewed clinical data from patients in Europe who received the product, and it looked at animal studies. It was approved as "safe," but its "effectiveness" -- a more stringent requirement -- was only required to be shown in a post-marketing study. (This is not an unusual practice; many products are approved this way.) It was the results of that post-marketing study that gave the impetus for the recall. Extrapolating data from 792 patients, the company found that the Silzone leaked in 2 percent of the patients, in comparison to 1 percent with its older product. (In this case, the somewhat murky distinction between "safe" and "effective" appears to have blurred to the point of unrecognizability: The Silzone presumably is not only less effective than the earlier model but less safe.)
"What we're seeing is that harmful products, be they drugs or devices, are being approved, and then introduced into unwitting people who think they have been thoroughly tested for their safety when obviously they have not," says Vera Sharav, president of Citizens for Responsible Care (CIRCARE), a human rights organization.
But Peter Gove, a spokesman for St. Jude, says that not only did the company meet FDA requirements, it went beyond them when applying for the pre-market supplemental approval. Clinical data was not required, he says, yet the company submitted it anyway. "We did all of the appropriate pre-clinical and animal testing," says Gove. "If we did not, the FDA would not have approved this as a supplement. Any lawyer can Monday-morning quarterback this and say 'I wish they would have done this and that,' but the fact is the FDA wouldn't have approved this, or even considered it, if we hadn't met their requirements. It's easy to say two or three years later, 'They should have done more testing.'"
Gove also says only a "very few" patients had to undergo revision surgery as a result of the recall. (He would not comment specifically on the Baez case because of the legal proceedings.)
In contrast, approximately 351 people so far, or about 2 percent of the total number of patients, have had to go back under the knife for hip replacement surgery after Sulzer Medica issued a recall of its Inter-Op Acetabular Shell last December. An estimated 17,500 patients received the device. Many of the devices had residual mineral oil from the manufacturing process, which reportedly made it difficult for the pelvic bone to adhere to the prosthetic device.
Rhonda Silva was one of those recipients. The 48-year-old Oakland, Calif., resident first had the surgery last April because her arthritis had progressed to the point where she was popping painkillers just to stay out all day and walk around. She says she was told after the surgery that she would be laid up for just a matter of weeks and then could return to her normal life. But after the first Sulzer implant created slippage, her doctors -- before the recall -- put in another Sulzer implant. And now that, too, she says, is failing. Her third procedure is scheduled for this month.
"When one thinks of a recall, one thinks of a car, one thinks of tires, you don't think of body parts," says Silva. "You think, 'This can't possibly be happening to me.' It's really like living in a nightmare."
That nightmare has manifested itself in many ways, most visibly on her left hip, where there is a purplish-black 14-inch-long incision that, she says, has become infected. But the public relations executive is most upset about the timing. She had her second surgery in November, two months after the company says it had received word from surgeons that there might be problems with the device. The company issued a recall on Dec. 5. In other words, not only did Silva receive the same defective hip implant twice, but when she received the second one the company already had reason to be suspicious of it. Silva decided to sue.
Sultzer spokesman Jim Moore says he believes that most of the people who will need revision surgery have already surfaced. Typically, he says, problems present themselves within two or three months of the operation, and it's almost that time now. But, still, he says, this type of manufacturing malfunction rarely happens, and the company is doing some soul-searching as to how things went so very wrong.
"We feel worse than bad," says Moore. "This is a company that has decades of success, improving the quality of life for hundreds of thousands of people each year. Everyone is profoundly disturbed by this failure. People are working 20 hours a day to help the people we have hurt, who we normally would have helped."
Moore says that Sulzer is covering the costs of the revision surgery, the ensuing doctor visits and any out-of-pocket expenses. For those who have received the device but haven't experienced any problems, the company isn't paying for any additional follow-up, since Moore says it is typical postoperative protocol for the patient to be checked up on by his or her physician anyway.
However, many believe that is not enough. A class action suit was filed two weeks ago on behalf of all those patients who haven't experienced any problems yet, but say they have to live with the day-to-day fear that it's just a matter of time before the implant will fail. They want Sulzer to pay for additional monitoring by their physicians just in case something should go wrong.
But not all of those in the field think that implant recalls are a serious problem. "I don't think the numbers that we've seen are a reason for public alarm at all," says Mark Bruley, vice president for accident and forensic investigation at ECRI. Bruley says that we're seeing more recalls because an aging population is using more implants. In addition, he says FDA's MedWatch system, which ensures that manufacturers alert the public when recalls take place, is another safeguard.
Still, for those thousands of patients who ended up with a product that slipped past all the oversight, this type of explanation provides little solace. "I have constant sleepless nights because I'm in pain," says Silva, the hip implant patient. "But the point is that it's just not the physical pain -- it's constantly worrying whether I'm ever going to get well."