Doctors see flaw in device recalls

Linda Mant says her daughter once received a recall notice for her Volkswagen because of an electrical problem. But when the drug-injection port implanted in Mant for her cancer treatments was recalled in March because it might leak, she only found out through her doctor. She was not contacted by the port's maker, Boston Scientific Corp.

Mant, a Falmouth elementary school teacher, wishes the company faced more pressure to get word of the flaw to her directly.

A spokesman for Boston Scientific said the Natick company acted properly. But how much medical-device makers must reveal about problems with their products is becoming a hot topic in the growing industry.

Each month, new implantable devices to aid everything from heartbeats to hearing are introduced to the market. Some are prone to defects, usually minor, that might not crop up until after thousands of the artificial parts have been placed in patients.

The Food and Drug Administration often requires companies to notify doctors of serious problems, and gives healthcare providers the responsibility for contacting patients. But after several recent high-profile recalls, some doctors are starting to argue that patients should be directly told of recalls by manufacturers.

''If your car tires have the potential to malfunction, you as a car owner get a letter," said William H. Maisel, a cardiologist at Brigham and Women's Hospital in Boston. ''It's remarkable to me that if you have a [problem] device, you are not notified directly."

Christopher J. White, a New Orleans cardiologist who last summer dealt with a recall of cardiac stents that affected some of his patients, said he also would prefer a direct notification system. ''It wouldn't take a deep or difficult database to send out a card to everyone," he said.

Both doctors advise the FDA on devices related to the bloodstream, such as the types of implantable defibrillators that Guidant Corp. began warning doctors about in May because of the risk of a short-circuit that could be fatal. Defibrillators deliver a shock to the heart when it stops beating correctly, but the devices in question might not work as designed when needed.

The company recalled the defibrillators June 17, and already faces at least three lawsuits from patients who were given the devices. One suit, filed June 1 in US District Court in Indiana, seeks to force Guidant to provide ''notice to all patient recipients" telling them about ''the potential of the device to fail."

Stephen Seller, a Philadelphia attorney, said the majority of the 20 patients he represents who received a Guidant device heard about the recall from news reports. ''We've already seen problems where physicians aren't getting in touch with patients quickly," he said.

A Guidant spokesman said the company would not discuss pending litigation. Robert B. Nicholas, who represents some medical-device companies as head of the FDA practice at the law firm of McDermott, Will and Emery in Washington, said companies sometimes negotiate with regulators to avoid the bad publicity associated with recalls. Also, Nicholas said, sending notices to all consumers might needlessly worry some of them because they are not as well informed about the issues as their doctors.

''You don't want someone to be panicking over these situations, you want them to have a reasonable discussion" with their physician, Nicholas said.

He added that direct-to-consumer notices, while rare, are sometimes required. In March, for instance, the FDA issued a warning saying patients could become trapped and suffocate between the mattress and rail of restraining beds made by Vail Products of Toledo. In addition to seizing beds from the company's stock, the agency released a notice stating that it ''expects the firm" to address any safety problems with beds already sent to hospitals or private homes.

Vail denied the allegations, but a recorded message at the company's phone number said it closed because of the FDA's actions.

Medical-device makers sometimes issue press releases detailing recalls. The FDA's press office didn't make officials available to be interviewed for this story.

Janet Trunzo, vice president of regulatory affairs for the device industry's trade group, the Advanced Medical Technology Association, said the FDA lately has been expecting companies to issue press releases in the case of so-called class 1 recalls, those posing the greatest risk.

Other recalls, like the one Boston Scientific initiated for its Vaxcel drug-injection port that Linda Mant received, are only made public weeks or months after they take place, through enforcement reports posted on the FDA website.

Infusion ports feature a circular silicon-like surface implanted under the skin, often just below the clavicle. Needles poked through the surface deliver drugs that flow through a catheter surgically attached to a vein, simplifying treatment for those who need frequent injections.

Since March, Boston Scientific has recalled 2,000 Vaxcel ports after complaints that some had broken apart, which could cause them to leak drugs. The company told doctors to consider surgery to replace the devices in some patients.

Mant had a new port implanted in April, but said she wasn't aware of the extent of the problem until this month when she read a newspaper story based on an FDA enforcement report.

Advanced devices pose technical challenges, she said, but patients need to be fully informed about any glitches as soon as they become known. ''As a consumer, it's buyer beware, and yet when you're a medical patient, you're not necessarily thinking in those terms," she said.

Ross Kerber can be reached at kerber@globe.com.