A new study conducted in Europe has questioned the long-term effectiveness of the popular Lap-Band weight-loss device, finding that many patients suffered major complications and half of them eventually had the device removed.
The report, published Monday in the Archives of Surgery, focused on 82 surgeries performed between 1994 and 1997. Even though patients reported losing significant weight, complications such as band erosion and infections led researchers to conclude the surgery had "relatively poor long-term outcomes."
The Lap-Band, manufactured by Irvine-based Allergan Inc., is a silicone ring that's surgically fitted over part of the stomach to discourage overeating.
Because the device was approved for use in the United States in 2001, long-term research has focused on surgeries performed abroad. Jacques Himpens, the lead author of the study published Monday, works with the European School of Laparoscopic Surgery at Saint Pierre University Hospital in Brussels.
Allergan officials criticized the study, saying it was flawed and contradicts other studies that have found the device safe and effective. A 2004 study, for instance, found that just 17% of patients had opted to have their bands surgically removed, said Caroline Van Hove, an Allergan spokeswoman.
In the Belgian study, researchers contacted 151 patients but just 82 responded, a ratio that could skew study findings, Van Hove said. Surgeries and follow-up care have changed dramatically in the last 15 years, making the findings much less relevant, she said.
"These were among the first patients treated anywhere in the world. The surgeons were at the bottom of their learning curve. It is misleading to report these patients as if they represent what can be expected … today," Van Hove said in a statement.
The Lap-Band is heavily marketed on Southern California freeway billboards as well as on television, radio and through direct mailings by a marketing company called 1-800-GET-THIN, which refers prospective patients to surgery centers.
Allergan does not pay for the advertisements, which were criticized recently by the company's chief executive, David E.I. Pyott. Allergan recently sent advertising guidelines to physicians, saying any marketing should "provide balanced information about benefits and risks related to the procedure."
Four patients have died within the last two years following Lap-Band surgeries performed in Southern California, prompting medical malpractice lawsuits and investigations by the Medical Board of California.
None of the patients involved in the European study died as a result of the surgeries. But 32 of 82 reported major complications, and 49 of them had additional surgeries, either to correct problems or because of a lack of weight loss.
The study found that many surgeons in Europe are opting for a more invasive gastric bypass surgery. The trend is the opposite in the United States, where gastric banding is more common than bypass surgery, the report said.