News Alert: Boston Scientific Initiates Voluntary Recall of Enteryx

By: Jean Johnson for Reflux1

Enough problems have developed with the use of Enteryx that on September 23, 2005, Boston Scientific Corporation initiated a voluntary recall of the product. Initially thought capable of bringing relief for symptoms of GERD (gastroesophageal reflux disease) – commonly called acid reflux or heartburn – Enteryx had been largely successful in treating patients that suffer when stomach acids back up into the esophagus.

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Patients who have had the Enteryx Procedure within the last 30 days can expect either a phone call or letter from their physician notifying them of the recall. As a precautionary measure, patients are being asked to schedule a follow-up appointment, the expense of which will be covered by Boston Scientific. At the appointments, physicians will check for any symptoms that might indicate potential problems. For more information on the Enteryx recall, visit Boston Scientific American Gastroenterological Association Prior Alerts U.S. Food and Drug Administration (FDA) Oct. 2004 Patient Caution Boston Scientific July 2004 Safety Alert

A company statement underscores that the recall “is not related the safety of the Enteryx product” itself, but rather “based on the procedural injection technique.”

Enteryx is a polymer that physicians inject directly into the walls of the esophagus where it thickens and helps block acid from flowing upward from the stomach. The technical difficulty of this performing this procedure correctly has resulted in an 11 accidents where physicians punctured the wall of the esophagus. In one case, death occurred in an elderly patient when a physician accidentally went through the esophagus far enough to puncture the aorta, the body’s largest artery stemming from the heart.

Perforation of the esophagus is most commonly associated with some type of medical procedure like esophagoscopy (a procedure used to examine the esophagus) or naso-gastric feeding tube placements. Pain is often the first symptom, although the condition can lead to shock and death if untreated.

Further symptoms associated with shock and include rapid breathing and heart rate combined with a drop in blood pressure. Patients who have experienced a puncture in the upper part of the esophagus often have neck pain and air bubbles present under the skin as well, whereas those with breeches in the middle and lower section of the esophagus can experience difficulty swallowing, chest pain, and shortness of breath.

No matter the location, surgery is required to repair the damage. Patients that get help within the first 24 hours have a 90 percent rate of survival. For those who do not get immediate attention, however, chances of death increase to 50 percent.

According to chief of endoscopy at Beth Israel Deaconess Medical Center, Ram Chuttani M.D., performing the Enteryx procedure is very technically demanding. He told the Associated Press that although his hospital has done 40 to 50 of the Enteryx procedures, “it is quite difficult to control even in the best settings. Even in experienced hands when you inject, you cannot be absolutely certain where the Enteryx is injected.”

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This illustration shows the proper injection of a liquid copolymer into the muscle layer of the esophagus. Source: U.S. Food and Drug Administration

According to a Boston Scientific statement, not only do physicians have difficulty knowing if they’ve injected the Enteryx correctly, “there have been a limited number of injections through the wall of the esophagus that were undetected at the time of the procedure and resulted in adverse effects. Boston Scientific considers this an unacceptable risk and has elected to recall these products.”

Paul Donovan, company spokesman underscored that the corporation has no evidence of longer-term complications. Thus consulting with the Federal Drug Administration on ways to proceed, Boston Scientific opted for an indefinite recall, notifying “hospitals and physicians directly, providing them with a packet of information that includes information about the recall, as well as recommendations to physicians to follow-up with patients who have been treated with the Enteryx Procedure within the last 30 days.”

Charles Lewis, retired mechanic of Vancouver, Washington, Oregon, has suffered from acid reflux for several years. Although he’s not had the Enteryx Procedure, he remains philosophical. “Modern medicine in the United States has brought many, many blessings to Americans and people beyond our borders. I know it’s tough, but we have to expect that problems and upsets will happen as our experts learn to work with the available technology,” said Lewis. “We tend to think of our doctors as invincible, but the way I look at it they’re human like the rest of us. It’s just that instead of working on cars like I used to do, they work on human bodies – so we outside the medical profession like to fool ourselves into thinking that they never make mistakes. That’s just not reasonable, and so we’ve got to take our lumps along with all the blessings.”

Last updated: 29-Sep-05