MAUDE Adverse Event Report: ALLERGAN GASTRIC LAP BAND; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Patient Problems Dysphagia/ Odynophagia (1815); Dyspnea (1816); Unspecified Gastrointestinal Problem (4491)

Event Type  Injury  

Event Description

Reporter called to report that her gastric lap band was implanted approximately thirteen years ago (2011), and it has been causing her multiple health and medical issues since then.She is experiencing shortness of breath, swallowing problems, gastro-esophageal reflux disease (gerd), joint problems and not feeling well overall.Reporter also stated that in the same period of time she has had non-hodgkin's lymphoma where, there is no family history of any of the illnesses as listed above and that she was very healthy prior.Reporter stated that she is upset that before surgery, her doctor told her that there is less than a 1% chance of complications with this device but has recently learned that there is a 50% chance of complications with the device.Additionally, reporter was told that the lap band is a device that would last her a life time where, she learned that it has a 7 to 10 year lifespan and her lap band is now 13 years old.She was never contacted by the manufacturer or her healthcare professional(s) about any of this information.Reporter states that now she will need to have additional surgery to have it removed.

• Brand Name: GASTRIC LAP BAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 17745176
• MDR Text Key: 323546314
• Report Number: MW5145608
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Female