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FDA withdrawal

Allergan drop plans for adolescent Lap-Bands

90% of gastric bands used in the USA are Lap-Bands, made by Allergan.
Allergan confirms end of seven-year application process
Withdrawal adds to company's Lap-Band woes
Company stands behind device's adult safety and effectiveness record

Allergan have confirmed that they have abandoned plans to market their Lap-Band gastric band to obese adolescents in the US, bringing to an end a seven-year application process.

The California-based company first announced their intentions in February this year. A spokesperson for the company says that the decision is due to shifting priorities in research and development resources.

The announcement comes as Allergan struggles to protect its market share for their device, facing increasing scepticism from the medical community about the efficacy of gastric bands.

Studies into the use of Lap-Bands in adolescents have taken place in the USA since 2005. Allergan says that these studies will continue.

Troubles

While the company, which sells medical products in a range of specialties including plastic surgery, ophthalmics, neuroscience and dermatology, remains profitable, its obesity intervention business has struggled: in 2012, their second-quarter year-on-year sales dropped by 24.1%.

In an August earnings call, Allergan CEO David Pyott said that the results were due both to a shrinking bariatric market, and a decline in the number of gastric band operations performed in the USA.

The procedure’s market share dropped from more than 40% in 2011 to 33% in May 2012, almost being passed by the increasingly popular sleeve gastrectomy, which constituted 31% of the market in the same quarter.

A recent series of studies have also questioned the device’s safety and efficacy. A 2011 study investigating the long-term outcomes of laparoscopic adjustable gastric banding, published in the Archives of Surgery, found that 48.6% of the participants needed their bands removed, and excess weight loss was 42.8% at 12 years.

A recently-published 10-year study found that bypass patients were likely to lose more weight and keep it off for longer than band patients. Another recently published six-year case-matched study reported that Roux-en-Y gastric bypass is associated with better weight loss, resulting in a better correction of some comorbidities than gastric banding.

Reporting on the results of an international survey into surgery trends, American bariatric surgeon Henry Buchwald recently said that he thought the gastric band procedure would “more or less disappear” in the near future.

However, Heather Katt, a spokesperson from Allergan defended the efficacy of their device, saying, “the Lap-Band AP system has an 19-year safety and effectiveness record with more than 650,000 procedures performed to date, leading to more than two million patient years of exposure for the device. Adverse events have been reported in less than two percent of patients.”

Allergan also face criticism in America from Congress. Some Democrats have called for hearings into whether the FDA failed to protect the public from the risks associated with the Lap-Band, combined with aggressive and misleading marketing from some providers.

The FDA originally approved the use of the Lap-Band in 2001, for the use in adults with a BMI of over 40, or a BMI over 35 with associated comorbidities. In 2011, they expanded their approval to include adults with a BMI of over 30 and associated comorbidities.

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