New Lap Band Safety Data May Prompt Congressional Hearings
Please note, The Schmidt Firm, LLP is no longer accepting Lap Band claims. If you feel that you may have a potential case, we urge you to locate another law firm adequately suited to handle your claim.
January 23, 2012 — House Democrats are calling for Congressional hearings following a new study of Allergan’s Lap-Band, which found that half of people with the device did not lose weight, and 40% suffered serious complications. Many are concerned because there is a high rate of patients needing follow-up surgeries after they receive the implant, increasing their risk of death or serious surgical complications. Congress is considering an overhaul of the FDA rules for medical devices following a series of high-profile incidents, leading some to believe that the FDA device regulations are ineffective to protect the public from dangerous medical devices.
The Lap Band study was published in Archives of Surgery, which studied the recipients of Lap-Band over six years. The study found that almost half of the patients with the band had no weight loss or needed the device removed after six years. In addition, more than 40% had long-term complications.
Other Studies of Lap-Band
- Belgian Study: Found that nearly half of adult patients had their bands removed within 12 years. Reasons for removing the bands included: they did not lose weight, they regained weight they lost, they had heartburn or vomiting, or the band slipped and perforated their stomach.
- German Study: Found that 30% of patients needed new operations within 14 years.
- Australian Study: Found that 1/3 of operations on teenagers required follow-up surgeries within two years, most often because they had stretched their stomach by eating more than the small pouch would hold.
Allergan, Inc. has responded to all of these reports in the same way, saying that the studies used small sample sizes, and only studied an older gastric band and an older surgical technique. They said that using current techniques, the rate of patients needing a follow-up operation is three times lower.
The U.S. Congress has until October 2012 to decide whether they will authorize funding to the FDA review of medical products. The FDA has recently come under fire for problems with a variety of medical products: transvaginal mesh, defective artificial hips, implanted brain stents, and the Lap Band.
The rate of Lap-Band surgery has exploded recently in the U.S., with a six-fold increase in the number of surgeries in Southern California alone. The procedure only has FDA-approval for use in people who are morbidly obese who have failed to lose weight through traditional methods. It is not recommended as a primary option for weight loss because the risk of complications includes death. Obese people are at a higher risk of death during surgery, and because people who get the Lap-Band must often undergo multiple surgeries, the risk of dying or suffering other complications is increased. Even so, obesity itself is a life-threatening condition, and for some people, the surgery may be worth the risk.
Complications from the Lap-Band include:
- Dying during surgery
- Stretching the stomach
- Vomiting repeatedly, damaging the esophagus
- Band slippage, requiring additional surgery
- Band erosion into the stomach or nearby tissue
- Band perforating the stomach
California Democrat Henry Waxman is calling for the Congressional Hearings. The rate of Lap Band surgery has undergone a six-fold increase in the last five years in the state of California alone. The lawmakers have yet to decide whether they will have the proposed hearing.
How do I contact a Lawyer for a Lap Band Lawsuit?
The Schmidt Firm, LLP is currently accepting Lap Band induced injury cases in all 50 states. If you or somebody you know has been injured by the Lap Band, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Lap Band Litigation Group or call toll free 24 hours a day at (866) 920-0753.
Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.
Related Posts
Free Case Evaluation
The Schmidt Firm, LLP has been recognized as one of the nation's leading plaintiff's law firms and handles cases in all 50 states. We are very proud of our legal achivements, but equally self-respecting of our firms reputation for providing personal attention to each and every client we represent.
No matter what type of case you have, you may contact us with confidence by filling out the email contact form below or calling us directly by dialing toll free 24 hrs/day (866) 920-0753.