Hundreds of patients may need surgery to remove an implanted drug-injection device made by Boston Scientific Corp., the company said yesterday after federal regulators cited it for quality-control problems.
A spokesman for the Natick medical-devices giant said it has been advising doctors to consider surgery if their patients have one of the 1,000 drug-infusion ports it recalled in March. In addition, the company said it will recall another 1,000 ports this week, in response to a warning letter it received May 18 from the Food and Drug Administration about quality-control standards.
The letter, which was posted yesterday on the FDA’s website, said Boston Scientific failed to establish manufacturing controls for the quality of the devices and did not properly track quality concerns.
The problems could cause the ports to leak drugs into unintended parts of the body, though the company said it knew of only one possible report of a patient injury. Boston Scientific said the company would take charges totaling $2 million to resolve the issues. The amount is financially insignificant for the company which had 2004 sales of $5.6 billion but company spokesman Charles Rudnick declined to say whether that was the reason the company didn’t publicly disclose the problems to investors earlier. He said the company ”fully complied with all requirements regarding notification.”
The FDA’s letter directed the company to fix problems it called ”serious violations of the law” that could result in fines, product seizures, or other penalties. The language was stronger than any communication Boston Scientific received from the agency last year when the company launched three recalls to fix manufacturing flaws in its most important product, a cardiac stent.
Boston Scientific shares fell 86 cents yesterday to close at $27.09, their lowest close in a year, though several financial analysts said other factors may be driving the stock’s decline. Last week, the company lowered its earnings expectations for the year.
Infusion ports make it easier to treat cancer patients and others who need frequent drug injections by avoiding repeated needle-sticks directly into a blood vessel.
Typically, the ports feature a circular surface made of silicon-like material about the size of a 50-cent piece that is implanted under the skin, often just below the clavicle. Needles poked through the port’s surface deliver drugs that flow through a catheter surgically attached to a vein.
The technology became widely used by the 1990s. Boston Scientific calls its latest versions ”Vaxcel Low Profile Infusion Ports” and says they close more effectively than earlier models, reducing complications.
According to the FDA’s letter, Boston Scientific started reviewing its manufacturing procedures Aug. 26 after receiving a complaint that the two plastic pieces that form the port’s cover and base had separated, possibly because they weren’t correctly welded.
It received at least four more complaints through Feb. 9, and on March 9 launched a voluntary recall of all 1,000 ports it had shipped to date that included valves to stop blood from flowing up from the catheter to the reservoir.
At the time, Boston Scientific said it didn’t need to recall ports made without valves because the company hadn’t received complaints about those models. But the FDA’s letter said it did receive a complaint Jan. 5 about a ”leak in the membrane” of a nonvalved port.
The company was warned for failing to maintain adequate procedures to identify actions ”to correct and prevent the recurrence of nonconforming product and other quality problems.”
Rudnick said the cause of the leak reported Jan. 5 was ”inconclusive.” But he added the second recall was meant to address all the FDA’s concerns, pending another meeting with the agency expected within a week.
Of the 1,000 ports that have already been recalled, Rudnick said the company is working to determine how many have been implanted in patients and that it is only advising doctors to consider removing the devices.
The ports typically are removed after about six months, he said. The company isn’t advising doctors whose patients have the other type of port to consider having them removed because it hasn’t received any reports of the port’s cover and base separating, he said.