December 6, 2010

Recall Surgeries Panic Patients

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A dozen patients of a Wallingford orthopedic surgeon recently received frightening phone calls from their doctor.  The hip replacement part that Dr. Alfredo Axtmayer implanted in them had been recalled by its manufacturer because of a higher than expected failure rate that could harm their bones, blood and tissue.  If the tests showed problems, a patient might need another operation to remove and replace the device.

Similar calls and letters were sent by other doctors in Connecticut and around the country who had used the recalled device. Their patients had reason to be worried.  They had already endured a process that likely entailed about a three-day hospital stay and about a month of recovery with physical therapy and walking with a cane or crutches. Usually, the operation is performed as a last resort after long term experience with pain and limits on daily activity.

Axtmayer’s patients appear to be doing well. “So far, one patient, a very obese lady, has had some pain,” he said. Testing hasn’t revealed problems with the device in any of the patients, some of whom have had the implant for three years. The surgeries were performed at the Hospital of St. Raphael in New Haven and Mid State Medical Center in Meriden.

Axtmayer’s patients are among 37,000 in the United States who had hip implants that were recalled by DePuy Orthopaedics, a medical device manufacturer and a division of Johnson & Johnson.  The recall was prompted by data in England and Wales that showed that after five years, 13 percent of patients who had the devices needed to have them removed and replaced in a subsequent surgery, called a revision. This compares with an expected experience of 5 percent revisions in five years, according to Lorie Gawreluk, DePuy vice president of worldwide communications.

The recalled model is the ASR XL Acetabular System, a “metal on metal “ system that used large components designed to facilitate range of motion.  It follows recalls of hip implant devices by other major implant device manufacturers including Stryker and Zimmer.

Gawreluk said the company doesn’t break down the number of ASR XL systems sold in each state. Dr. Vipul Dua, of Sports Medicine Partners in South Windsor, said he had used it in two surgeries at Rockville General Hospital in Vernon. He said recently that one patient’s tests were fine and the other patient was still undergoing testing.  Dr. John Irving, of The Orthopaedic Group, in the New Haven area, sent certified letters to 30 of his patients.  Of the 30, three needed second operations, and there are “two cases that I’m watching” to see if surgery will eventually be required, said Irving, who added that he performed the surgeries at Yale New Haven and Milford hospitals. His partner, Dr. Christopher Lynch, also used the device, Irving added.

Dr. Daniel Glenney, of Norwich Orthopaedic Group in North Franklin, did too, according to a staff member at his practice.  He didn’t return phone calls from C-HIT.

Out front in a new nationwide device data collection effort is Hartford’s St. Francis Hospital.  Its Connecticut Joint Replacement Institute is participating in a pilot registry to track patients, their devices and doctors to establish a permanent history for each procedure. It aims to detect problem devices sooner and thus, reduce the need for second surgeries, known as revisions. The goal is to have 90 percent of surgical hospitals nationwide participate in the American Joint Replacement Registry, according to a registry spokesperson. St. Francis had a head start because it has a registry of about 6,700 patients that it started in 2007 when it opened its Joint Replacement Institute.

“The purpose of the registry is don’t wait until there’s 100,000 people who have a device in, before you know you have a problem,” said Dr. Courtland Lewis, the institute’s director of quality and research.  By the time DePuy recalled the ASR along with another hip system that was used outside the U.S., 93,000 people worldwide had already had surgery using one of the two recalled systems.

Lewis said it’s important to reduce the need for revision surgeries. “It’s a much more difficult operation the second time around,” he said. He explained that a second operation could take two to three times longer than the first and there’s likelihood of blood loss and other complications because of more scar tissue and less bone to work with. He said he believes even a 5 percent revision rate is too high.

Reports of he DePuy recall led to medical malpractice lawyers advertising for potential clients who had the recalled implant. Since many people didn’t know the brand and model of their implants, panicked patients barraged doctors’ offices with phone calls to find out if they had the recalled device. A Greenwich practice, Orthopedic and Neurosurgery Specialists, received so many calls from worried patients that it posted a message on its website assuring them that its doctors had never used the device, said Sally Frank, a spokesperson.

Dr. Jay Lieberman, head of orthopedics at the University of Connecticut Health Center, said   “when you get this recall thing going on, patients are calling.” He said, “people panic” partly because they mistakenly think it’s like a car manufacturer recalling brakes, when all brakes have to be replaced.  A medical device is taken off the market with the expectation that it has to be replaced only in some cases, he said. Lieberman said he never used the ASR XL.

The ASR XL is one of many implant systems and parts that DePuy makes. The company is reimbursing people for expenses resulting from the recall, including costs of tests, procedures, travel to appointments, and loss of pay from missed work, said Gawreluk, the spokesperson.
Dua, of South Windsor, found the ASR attractive because his patients sought better range of motion. Axtmayer said metal on metal was expected to be strong and durable.

But other doctors interviewed who didn’t use it noted such concerns as reluctance to try a new product and potential of a metal on metal implant dispersing metal ions into the body. Dr. Carmine Ciccarelli, of Enfield Orthopaedics, said he doesn’t use a product unless there are at least five or 10 years of data on it.  “The track record was not there yet,” he said, noting he uses other DePuy products .

The ASR XL was approved for use in the U. S. beginning in August, 2005 and recalled last August.  The company stopped supplying the devices last year “due to a decline in demand,” according to Gawreluk of DePuy. “The reality is,” she said, “by the time we did the recall, there was not much left on the market.”  Complaints from surgeons continued to be made to the U. S. Food and Drug Administration (FDA).  According to the most recent FDA statistics provided in an emailed response to questions, more than 1,000 doctors have complained about the device: 66 in 2007; 173 in 2008; 275 in 2009; and 525 to date in 2010.

The ASR XL was approved in an expedited FDA process that is used for devices considered to be similar to ones already on the market.  The FDA has been widely criticized for its use of the system called 510(k).  Changes in procedures are to be adopted beginning in early 2011, and will include requiring more safety information from manufacturers.

Nationally, 350,000 hip replacements and 575,000 knee replacements are done annually. The number is expected to grow and improvements in devices sought as Baby Boomers continue to age and expect to lead active lives.  Lieberman of UConn explained, “patients have more expectations for quality of life than before.”

Peggy McCarthy can be reached at mccarthy@c-hit.org

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