The U.S. Food and Drug Administration (FDA) believes surgical centers that implant the Lap-Band Adjustable Gastric Banding System use false advertising that fails to inform recipients of the risks and subsequently injures them with potentially deadly side effects. The Rottenstein Law Group, a Lap-Band law firm, compassionately advocates for those who have suffered Lap-Band side effects. If you underwent a Lap-Band implantation procedure and believe it harmed you, contact RLG for a free, confidential legal consultation immediately. We will evaluate your case and remain on the lookout for Lap-Band recalls and Lap-Band class action lawsuits.
What Is The Lap-Band Adjustable Gastric Banding System?
In February 2011, the California-based company Allergan, Inc. obtained FDA approval to sell the Lap-Band Adjustable Gastric Banding System. Allergan designed the Lap-Band to help obese recipients (Body Mass Index 30-40) who have type 2 diabetes or hypertension and those with a Body Mass Index over 40 who have not found success with conventional weight-loss methods. Unlike other weight-loss products, the Lap-Band is mechanical, not nutritional. It is a fluid-filled band that the surgeon clamps to the upper area of the stomach, and it is connected to an access port placed near the recipient’s skin. The band constricts the stomach and reduces the amount of food the stomach can contain at any one time. As a result, the recipient eats less and loses weight. If necessary, the surgeon can inject or remove saline into or from the access port to tighten or loosen the band, respectively.
Lap-Band Might Cause Deadly Side Effects
Misleading Advertising, Unsafe Medical Practices
Lap-Band implantation procedures occur almost exclusively at eight surgical centers located in southern California. From December 9 through December 12, 2011, the FDA sent letters to these surgical centers and their marketing firm, 1-800-GET-THIN, LLC, informing them that 1-800-GET-THIN’s billboard advertising campaign was misleading potential recipients of the risks involved in undergoing a Lap-Band implantation procedure. The FDA stated that the Lap-Band billboard advertisements did three things contrary to regulations:
- They failed to “reveal material facts, including relevant risk information regarding the use of the Lap-Band, age and other qualifying requirements for the Lap-Band procedure, and the need for ongoing modification of eating habits, as provided in the approved Lap-Band labeling.”
- The advertisements did not “adequately state the Lap-Band’s relevant warnings, precautions, side effects, and contraindications.”
- The advertisements’ font sizes were too small to the point of illegibility.
According to the LA Times, two whistleblowers are suing the surgery centers for unsafe medical practices, including:
- Inducing patients to undergo unnecessary medical procedures;
- Defrauding insurance companies by billing them for procedures they never performed;
- Unsafe and unsanitary conditions; and
- Contributing to the deaths of five recipients.
High Rates of Reoperation
Long-term outcomes for Lap-Band procedures are also poor. A study published in the July 2011 issue of the medical journal, Archives of Surgery, investigated the outcomes of 151 adjustable gastric band recipients’ procedures. The researchers found that 22 percent experienced minor complications, 39 percent experienced major complications, including 28 percent reporting band erosion, and close to half had to have the gastric bands removed, which the researchers calculated at a 60 percent reoperation rate. The study concluded by remarking, “[Adjustable gastric banding] appears to result in relatively poor long-term outcomes.”
The U.S. Congress is aware of Lap-Band’s problems, and three representatives requested the leadership of the House Committee on Energy and Commerce conduct Lap-Band hearings.
RLG’s Lap-Band Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The Lap-Band lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Lap-Band lawsuit on your behalf if necessary. RLG will also keep you up to date on any Lap-Band class action lawsuits, FDA Lap-Band warnings, and Lap-Band FDA recall announcements. If you received Lap-Band and believe it harmed you, contact RLG today.