If you or someone you know has had lap band surgery and has been injured or has died as a result of a defective lap band product you may be in tiled to monetary compensation for the injuries created by the Lap Band. RepresentYou.com is a State Bar certified lawyer referral service which can refer victims of defective products to lawyers with a minimum of 20 years of experience, no disciplinary action and insurance. Our product recall lawyers, personal injury lawyers and defective medical device lawyers are trial tested and have had experience in dealing with defective products. If you have had Lap Band surgery and have any type of injury please contact RepresentYou.com to have a free consultation with a lawyer who can take your case on a contingency no win no fee basis, a contingency fee can mean you don’t pay unless you win.
Lap Band Lawyer
A Lap Band is a laparoscopic adjustable gastric band, in other terms it a belt that wraps around a persons stomach the laparoscopic ajustable gastric band is commonly referred to as a lap band, which is an inflatable silicone device that is surgically implanted around the top portion of the stomach, this can be done with laparoscopic surgery, the lap band is implanted in order to treat obesity. The adjustable gastric band surgery can be an example of bariatric surgery which is designed for obese patients typically with the body mass index also known as a BMI of 40 or greater-or between 35-40 however in some cases, patients who have other associated medical problems which could be greatly improved with weight loss such as: Sleep apnea, diabetes, osteoarthritis, GERD, Hypertension (high blood pressure), or metabolic syndrome, among others.
Medio February 2011: The Food and Drug Administration expanded approval of Adjustable gastric band to patients with a BMI between 30 to 40 and one weight-related medical condition such as diabetes or high blood pressure. However, an adjustable gastric band may only be used after other methods such as diet and exercise have previously been tried
LAP-Band FDA Information
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: LAP-BAND® Adjustable Gastric Banding System
PMA Applicant: Allergan, Inc.
Address: 71 S. Los Carneros Road, Goleta, CA
Approval Date: February 16, 2011
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/p000008s017a.pdf
What is it? The LAP-BAND® System is a surgically implanted device that helps adults, who are at least 18 years old, eat less and lose weight. The LAP-BAND® consists of a silicone band, tubing, and an access port. The inner surface of the silicone band is inflatable and is connected by the tubing to the access port.
How does it work? The band is placed around the upper part of the stomach during a surgical procedure. The band is connected to an access port that is placed close to the skin. Later, the surgeon can adjust the band (adding or removing fluid) by piercing the access port through the skin with a needle. The band creates a small stomach pouch that can hold only a small amount of food. The narrowed opening between the stomach pouch and the rest of the stomach controls how fast food passes from the pouch to the lower part of the stomach. Inflating the band (adding saline) makes the opening smaller, causing food to pass slower. Deflating the band (removing saline) makes the opening larger, permitting food to pass faster. The band limits the amount of food that can be eaten at one time and increases the time it takes for food to be digested, helping people to eat less.
When is it used? The LAP-BAND® System is used for weight loss in obese adults who have a Body Mass Index (BMI) of 30-40, with one or more obesity-related medical conditions (such as Type II diabetes and hypertension), and when non-surgical weight loss methods (such as supervised diet, exercise, and behavior modification) have not been successful. Patients must be willing to make major changes in their eating habits and lifestyle.
What will it accomplish? The LAP-BAND® System will help patients lose weight and maintain the weight loss, and it may help improve their health. In a U.S. study of patients with a BMI between 30-40, 80% of patients lost at least 30% of their excess weight and kept it off for one year. There were some patients who lost no weight and others who lost over 80% of their excess weight. The quality of life for patients enrolled in the study improved significantly.
When should it not be used? It should not be used for someone who is a poor candidate for surgery, has certain stomach or intestinal disorders, has to take aspirin frequently, or is addicted to alcohol or drugs. It should not be used if someone is not able or willing to follow dietary and other recommendations.
Additional information : Summary of Safety and Effectiveness and labeling are available online.
Lap Band Recall
LAP-BAND Adjustable Gastric Band System
Date Posted: November 18, 2010
Recall Number: Z-0418-2011
Product: LAP-BAND Adjustable Gastric Band System; Product codes: B-2105 (ACCSS PRT II KIT (0-10CC) US), B-2106 (ACCESS PRT II KIT (0-14CC) US), B-2210 (LP-BND SYS, 9.75, STER, US), B-2215 (LAP-BAND 9.75 W/ACC PRT II US), B-2220 (LP-BND SYS, 10.0, STER, US), B-2225 (LAP-BND 10.0,ACCESS PORT II,US), B-2255 (LAP-BAND VG W/ACS PORT II (US), B-2260 (LP-BND AP STANDARD SYS, W ACC PRT II), B-2265 (LP-BND AP LG SYS, W/ACC PRT II);
The Lap-Band System is a long-term implantable device intended to induce weight loss in morbidly obese patients by limiting food consumption restrictive and satiating, rather than malabsorptive). The device is surgically implanted, using either a laparoscopic or open procedure, to create a restricted opening (stoma) and a small gastric pouch to limit food consumption and induce early satiety. The main components of the device are the silicone elastomer band, access port. and kink-resistant tubing used to connect the other two components. The inner surface of the silicone band, which is placed around the stomach, is inflatable and connected by the tubing to the access port (a remote injection site. The access port is implanted on, or attached to, the rectus muscle to permit non-surgical, percutaneous adjustments to the band and thus, the stoma diameter, using sterile saline.
Code Information: All Lot Numbers for the listed Product Codes are affected by this recall.
Recalling Firm/Manufacturer: Allergan, 71 S Los Carneros Rd. Goleta, California 93117-5506
Reason for Recall: In a LAP-BAND System adjustment, failure to inject the needle perpendicular to the access port septum, as described in Directions for Use, may lead to port damage, resulting in subsequent port leakage. Leakage results in deflation of the LAP-BAND to its widest, open position requiring a procedure to replace the port. The patient may have symptoms of reduced satiety and increased appetite. Stalling
Action Allergan sent an URGENT FIELD CORRECTIVE ACTION letter dated September 15, 2010, to all affected customers. The recall communication was initiated on 09/16/2010 when the firm begin forwarding Customer letters with attached current Directions for Use distributed via Federal Express, with tracking verification provided by Federal Express, to the direct consignees. The Customer letters informed consignees of the products affected, description of the Issue, clinical implications and firm recommendations. Customers were instructed to follow the Directions for Use for inserting the needle. Customers were instructed to report any malfunction or adverse event related to the device to Allergan Product Support.
Lap Band Lawsuit
If you or someone you know needs to file a lawsuit because of injury or has death as a result of a defective lap band product you should contact RepresentYou.com, RepresentYou.com is a State Bar certified lawyer referral service which can refer victims of defective products to lawyers with a minimum of 20 years of experience, no disciplinary action and insurance. Our product recall lawyers, personal injury lawyers and defective medical device lawyers are trial tested and have had experience in dealing with defective products. If you have had Lap Band surgery and have any type of injury please contact RepresentYou.com to have a free consultation with a lawyer who can take your case on a contingency no win no fee basis, a contingency fee can mean you don’t pay unless you win.