Summary of MedSun Reports Describing Adverse Events With Adjustable Gastric Banding System
MedSun: Newsletter #39, August 2009

The Adjustable Gastric Lap-Band is a surgically implanted device used to help a person loss weight. The system consists of a hollow silicone band, tubing, and an access port. The band is placed around the upper part of the stomach, which creates a small pouch that holds a small amount of food. The narrowed opening between the stomach pouch and the rest of the stomach controls how quickly food passes from the pouch to the lower part of the stomach. Base upon the patient’s needs, the band can be inflated or deflated by adding saline through the access port. The access port is placed under the skin in a muscle in the chest wall (1).

Over the past two years, MedSun has received twenty adverse event reports associated with the gastric lap band device manufactured by two manufacturers: Allergan, Inc. and Ethicon Endo-Surgery, Inc. The reports were submitted by fifteen hospitals between June 2007 and June 2009. The problems reported were as follows:


• 9 reports associated with fluid leakage.
• 2 reports that involved out-of-box inflation problems (i.e. device would not inflate when the surgeon tested on the field prior to insertion.
• 2 reports of fracture of device material (port fractured).
• 2 reports that involved erosion.
• 1 report that involved a fragmentation of the band buckle.
• 1 report of slippage
• 1 report of failure to flush
• 1 report associated with detachment of components
• 1 report of internal/external damage

From the 20 reports received, one report involved a patient death and one listed a patient injury. There were two reports where the device type was not listed. There are 16 reports that mention a device malfunction. The patient injuries listed below were reported in 14 of the 20 reports.

• 13 additional surgical procedures required
• 1 sepsis/peritonitis
• 1 dysphagia
• 1 hospitalization
• 1 abdominal pain
• 1 erosion
• 1perforation of organ
• 1 nicks, cuts or tears of dura or other tissue

Of the reports that listed patient age, none listed patient age as less than 21 years, and 20 reports had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 17 reports involved female patients, and a total of 3 reports involved male patients.

These MedSun reports contributed to FDA awareness of the device problems. FDA continues to investigate these problems. If you have experienced these types of problems, please report them to the FDA.









Summary of MedSun Reports Describing Adverse Events between June 2007 and June 2009 With The Adjustable Gastric Banding System
Device Device Identifiers Event Description
Allergan, Inc. Lap-band Model B-2250 Lap-band device had defective tubing. It was broken and leaked fluid.
Allergan, Inc. Device Identifiers unknownLeak in lap-band tubing. The device was removed from patient.
Allergan, Inc. Device Identifiers unknown patient with history of morbid obesity with laparoscopic band procedure three or four years ago. Patient lost about 150 pounds. Patient developed severe upper abdominal pain, which brought her to the hospital for a workup. The patient required multiple exams, which included two esophagogastroduodenoscopy procedures. During the second procedure, a retroflexed view of the gastric cardia showed the eroded band visible in the gastric cardia mucosa. The mucosal perforation was noted with the band covering the opening. Twelve days later, the patient underwent laparoscopic surgery for removal of the adjustable gastric band and suture repair of the stomach. Per nursing notes, patient discharged in stable condition.
Allergan,Inc. /Bioenterics Inamed Lap-Band B-2220, SIZE - 10CM Inamed Bioenterics adjustable gastric banding lap band placed last year. Initially band was effective and patient was demonstrating good weight loss. Recently, the fluid in the lap band system has been slowly leaking from somewhere in the system with no liquid being in the band on re-checks. The physician felt the likely site of leaking was at the port. Patient was taken to operating room for replacement. Upon mobilizing the port from its facial attachment, it was brought up into the wound. A clamp was used to clamp the tubing distal to the port and then using a huber needle the port was accessed and saline was injected. A leak was immediately identified in the port at the junction between the rubber dome and the white plastic portion of the port. It appeared the port was leaking in this location and losing fluid. No other areas of leakage were identified. The port was removed and replaced with a new port. The new port was then accessed with a huber needle, saline was injected and it was determined port was watertight and holding the fluid with no problems.
Allergan, Inc./Inamed Device Identifiers Unknown Patient had lap band placed earlier this year. Patient returned for replacement of original lap band due to leak in band. Band would not retain saline. Upon removal the leak was noted to be in the actual band portion, not the port or tubing. Entire system replaced with new system.
Allergan, Inc./APS Access Port Lap-Band System B-2240 Patient required replacement of lap band due to leakage in the actual band portion, which inflates with saline to resemble an inner tube. Upon removal of entire system, surgeon examined the band again by putting fluid into the system. There was an obvious leak coming from the band. The band was placed approximately 21 months ago.
Allergan, Inc. /Lap-band Device Identifiers Unknown Port was tested and it failed because it was unable to flush fluid.
Allergan, Inc./Lap-band system vg with access port II low profile Device Identifiers UnknownPatient who had a lap-band placed earlier in the year had numerous adjustments for the lap-band. Patient noticed there was no limit to her satiety that had been present after initial surgery and she was gaining weight. She could eat large amounts and knew that was not normal. Surgeon suspected a malfunctioning port. It was not holding pressure and was recently replaced with a new lap-band port because of port leakage. The surgeon examined the old port, and clamped the tubing on the old port. He placed fluid into the port under pressure, and could see fluid leaking from the septum of the port. The port was saved.
Allergan, Inc. /Innerdyne Regular Device Identifiers Unknown There were no complications after surgery or subsequently, but then patient died a few weeks later from sudden onset of "sepsis due to peritonitis with ascites due to beta streptococcus group a wound infection," according to the autopsy report.
Ethicon Endo-Surgery, Inc. /Realize Device Identifiers Unknown The patient was status post gastric banding. He had received one 4 cc fill previously. During the fill attempt three months after banding, the physician was able to access the port w/o difficulty. He instilled 2.5 cc of saline with a bit of restriction to the fluid. He then could not withdraw saline after the instillation. Two other attempts were made with the same results. Fluoroscopic challenge was made at a later date; it revealed extravasation at the neck of the port. Subsequently, the patient underwent laparoscopic port replacement.
Allergan, Inc. /Lap-band Sytem Device Identifiers Unknown A gastric band that had been implanted for over a year leaked and would not retain the saline that was injected for restriction. The leak was in the tubing about 10 cm from the band itself, which could not have been caused by the patient or the surgeon.
Allergan, Inc. /Lap-band B2220 The patient was one year and four months out from laparoscopic adjustable gastric banding. The band demonstrated lack of restriction and was believed to have a slow leak. The physician took the patient to the operating room to remove the band.
Ethicon Endo-Surgery, Inc. /Realize Device Identifiers Unknown Patient was having dysphagia and pain. Patient had gallbladder surgery, and surgeon examined band site. Erosion identified and band was removed. The clear soft plastic to keep the device from cracking at the hub came away from the catheter, and slid down the catheter.
Allergan, Inc. /Calibration tube Device Identifiers Unknown We applied the stapler across initially, and then applied it again, this time we encountered a hard structure. It turned out to be a calibration tube which is a lap band-type tube which was placed by anesthesia in error. The stapler actually cut through part of the tip of the calibration tube. We had to open this area, and remove the remaining pieces of the calibration tube from the abdominal cavity. A portion of the staples had pierced the tube itself. Once this was done, it left an opening in the gastric pouch as well as the rim of the stomach and these were both repaired with the stapler. This is from the operative note.
Allergan, Inc. Device Identifiers Unknown A needle was inserted into the left upper quadrant beneath the costal margin in the midclavicular line. The abdomen was then insufflated with approximately 4 l of carbon dioxide with pressures not to exceed 17 mm Hg. Next, an 11-mm transverse incision was made approximately 2 cm superior and 2 cm to the left of the umbilicus. An 11-mm trocar and portal were inserted. The trocar was removed. The portal was connected to the insufflator. A light and video camera were connected to a 10-mm angled diagnostic laparoscope. At this point, it was felt that the anterio-posterior large lap-band would be the appropriate size. The lap-band was now introduced into the abdominal cavity using the band introducer through the 15-mm portal without difficulty. Attention was now focused on the 15-mm right upper quadrant port site. This incision was lengthened medially and laterally. At this point, we noted a small band fragment at the level of the fascia. This was approximately 5 mm x 2 mm x 0.5 mm in size. It was elected to reinsert the ports and inspect the band itself. Upon inspecting the band itself, there was noted to be a very small fragment of the leading shoulder to the buckle of the band with no other band injury. There was no apparent injury to the band itself. The cuff was now inflated under pressure, and 15 ml of fluid was added to the cuff with no apparent leak. These findings were discussed by telephone with technical representatives of the brand manufacturer, Allergan. Following discussion and further inspection of the band, it was felt that the integrity of the tubing band and cuff was intact. It was felt that there was a small fragment of the buckle missing. However, this did not affect the integrity of the buckle itself, and that we could safely leave the band in its present location. Pictures of this defect were made prior to removing the laparoscope and port.
Allergan, Inc. / Lap-band B2240 Allergan lap-band port fractured and had to be replaced with another lap-band by Allergan. The initial lap-band placement procedure was done at another facility.
Allergan, Inc. /Bioenterics Lap-band B-2250 When surgeon was testing the lap-band on the surgical field prior to insertion it would not inflate. The item was not used. Another lap-band was opened and used successfully.
Allergan, Inc. /Inamed Lap-Band System B2220 Patient had laparoscopic gastric banding done last year. The band failed and caused a leak. The patient had the band removed six months later and replaced with same type of implant.
Allergan, Inc. /Inamed Lap-Band System B2220 Lap-band "slipped." Initially, the lap-band was implanted a few years ago. The lap-band was removed and a new lap-band was implanted from the same manufacturer.
Allergan, Inc. /Lap-Band AP System Device Identifiers Unknown The lap-band device broke apart in two pieces when placing around stomach per doctor.




Additional Information:

1. LAP-BAND® Adjustable Gastric Banding (LAGB®) System - P000008. Online Available:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm088965.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun