[vc_row][vc_column][vc_column_text]Lap-Band surgery is one of several surgical procedures approved by the US Food and Drug Administration (FDA) to treat obesity. Surgery is an option for patients who previously tried and failed to lose weight with other medically supervised weight loss programs, such as behavioral alterations, pre-packed meals and pharmacotherapy. To qualify for Lap-Band surgery, patients need to have a Body Mass Index (BMI) higher than 40 or higher than 30 and suffer from a comorbidity, like high blood pressure, diabetes or heart disease.^[1]

While weight loss surgery is often a “last resort” for patients who need to lose weight, an increasing body of research evidence^[2] is revealing that bariatric surgery procedures such as Lap-Band surgery may in fact offer patients the best option for losing weight, since the procedures are proving to be both safe^[3] and effective^[2].

For Lap-Band surgery, treatment includes the placement of a silicone band around the stomach to reduce its size, as well as the connection to the band’s inflatable inner surface to an access port using a thin tube. The device, which is usually placed in the patient’s body through a minimally invasive laparoscopic surgery, limits food intake based on the tightness of the band, which can be adjusted by regulating the amount of fluid injected into the band by a physician.

Is the Lap-Band Safe? Lap-Band Safety Procedures

People often search the internet asking, “is the Lap-Band safe?” While there are some high-profile accounts of so-called “Lap-Band Horror Stories,” the Lap-Band surgery is a proven safe procedure, with a very low 0.1% mortality rate^[8]. The Lap-Band itself was approved by the US Food and Drug Administration (FDA) in 2001 after extensively reviewing safety and efficacy clinical trials for the device as well as the procedure. In addition, the company that commercializes the Lap-Band, Apollo Endosurgery, must continuously test and evaluate the device for safety in what are known as “FDA post approval studies.” The Lap-Band continues to show that it is both safe and effective for losing weight.

Obese patients often favor the Lap-Band^[5] because it is:

• Minimally invasive — the surgery can be conducted by making only a few small incisions.
• Not permanent — the gastric band can be removed at any time, unlike other weight loss surgeries, such as sleeve gastrectomy, which permanently change the digestive tract.
• Proven safe — most weight loss surgeries are safe and have low mortality rates, but the gastric band’s .1% mortality rate is compelling for patients.
• Proven effective — numerous clinical trials have demonstrated that the Lap-Band helps patients achieve weight loss and can also improve comorbidities, such as type 2 diabetes^[4].

In terms of safety, the device’s IDE study from 2007 sought to test the safety of the Lap-Band System using the incidence and severity of complication (device and/or procedure related). 135 women (90.6%) and 14 men (9.4%) were implanted with the device. At 12 months, 98 participants achieved 50% reduction of their excess weight loss, while 120 participants achieved a 30% reduction. In terms of safety:

• Only 7 participants — 4.7% of the study — required a reoperation.
• Of these, only 4 required an explantation (removal of the band) due to a serious adverse event.
• Additionally, there were 2 “port revisions” (repositioning of the port so that the band can be filled with saline), and
• 1 repositioning of band due to slippage.^[6]

It was this safety study that played a major role in the approval of the device in 2001. Since that time, additional studies are revealing that outcomes are in fact improving for Gastric Band and Bypass surgeries over time^[7].

Is The Lap-Band Safe? It Depends on Patient Compliance

The Lap-Band device and the surgery that is performed to insert it has continued to be deemed safe by the FDA. And yet, an increasing number of people are having the band removed, making for an increase in anecdotal stories suggesting that the device isn’t safe. The evidence, however, points to a lack of patient compliance with the device for causing many of the explants.

In order to ensure the safety and success of the Lap-Band procedure, there are some lifestyle changes that have to be made on the part of the patient. The eligibility of the patients for a Lap-Band surgery is very specific and should be discussed with a physician. The system is not recommended for patients younger than 18 years old, patients with conditions that may make them poor surgical candidates or increase the risk of poor results, including inflammatory or cardiopulmonary diseases, gastrointestinal conditions, symptoms or family history of autoimmune disease, and cirrhosis.

In addition, to ensure the safety of the patients, they need to be willing and able to commit to required dietary restrictions, as well as giving up alcohol and addressing drug addictions. Pregnant women are also not candidates for the Lap-Band surgery (though studies exploring the gastric band and pregnancy are beginning to explore its safety and effectiveness in that patient group as well).

However, the Lap-Band is indeed a long-term weight loss treatment and additional surgeries may be needed to enhance the results, correct potential problems and ensure the safety of the patient.

Potential Problems Associated with the Lap-Band

Despite the safety of the treatment, there are potential problems that can occur. While not all studies agree, one report found complications in 26% of Lap-Band cases^[8]. The possible side effects associated with the Lap-Band include:

• band problems
• blood clots
• bowel function changes
• bowel perforations
• esophageal dilation
• food trapping
• gallstones
• Gastroesophageal Reflux Disease (GERD)
• hiatal hernia
• indigestion (Dyspepsia)
• food intolerance, nausea
• vomiting
• pneumonia
• port problems
• pouch dilation

Based on the original safety and efficacy study from 2007 study cited above, the most common adverse events caused by the Lap-Band were vomiting (28.9% of the participants), indigestion (22.1%), acid reflux (14.8%), and nausea (5.4%)^[6]. Specialists argue that these adverse events can be mitigated by adhering to the best practices of the device.

In a consumer update from the FDA in 2001 entitled, “FDA Targets Gastric Band Weight-Loss Claims,” the issue of “binge eating” was directly addressed, with the Administration clearly stating:

Gastric banding requires a drastic diet change—you need to eat small portions frequently to prevent complications and ensure weight loss, says Lerner. “If you eat or drink more than your stomach pouch can hold, the pouch will stretch and food may back up into the esophagus. You may have nausea and vomiting, and require an adjustment of the band.”

And if patients eat a lot of fattening foods or drink milkshakes or other high-calorie liquids, they may not lose a lot of weight.

In conclusion, the answer to “is the Lap-Band safe?” is clearly “yes,” however, when it comes to complications and adverse events associated with the device, it is primarily up to the patient to ensure that they eat right in order to continue to lose weight and feel good.

References:

[1] FDA Approval for Lap-Band, February, 2011.

[2] “The Sleeve Bypass Trial: a multicentre randomized controlled trial comparing the long term outcome of laparoscopic sleeve gastrectomy and gastric bypass for morbid obesity in terms of excess BMI loss percentage and quality of life,” August, 2015. “Bariatric Surgery: Three Surgical Techniques, Patient Care, Risks, and Outcomes,” August, 2015. “Laparoscopic sleeve gastrectomy in obese Korean patients: up to 4-year follow-up in a single center,” May, 2015.

[3] “Is Laparoscopic Bariatric Surgery a Safe Option in Extremely High-Risk Morbidly Obese Patients?” August, 2015.

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