MAUDE Adverse Event Report: AP LAPBAND

Model Number 6DRYD-51

Device Problem Extrusion (2934)

Patient Problems Adhesion(s) (1695); Erosion (1750); Unspecified Infection (1930); Scarring (2061); Therapeutic Response, Decreased (2271)

Event Date 04/28/2014

Event Type  Injury  

Event Description

I had the allergan lapband placed in (b)(6) 2010.For two years, everything went as planned and then i had a slip in spring 2012.I had all of the fluid removed from the band but still couldn't eat like i felt i should have been able to.This became worse over the next two years, and this year i decided that i may have failed at the band and went to a different surgeon and just wanted it removed with nothing else being done.I learned from someone who worked at this office that she too had a difficult time with the band to the point of hospitalization because of not being able to eat.They found that her problems were scar tissue built up under the band to the point of closing the opening to merely pin hole sized.I decided to go through the process and have the sleeve.During a routine endoscopy, they found that my band had eroded into my stomach and this was why i was having the eating problem.I had it removed on (b)(6) 2014 and they found that i had several (7) adhesions that had to be repaired, the band had eroded into my stomach in two separate places and i too had the build up of scar tissue under the band.I have been almost a month recovering and it has been a very rough month.I had to have a drain left in me for a week to help with the removal of infection.Now i have to wait 6-8 months before they will do another endoscopy to make sure the esophagus and stomach have healed to do a sleeve.There is the possibility that the sleeve will not be able to be done.The rate of erosion in patients is severely higher than what is being reported.The scar tissue that grows under the band like a callus is not something that was ever even discussed and the fact that it cannot be seen in an x-ray or an endoscopy is rather dangerous.I did not have typical signs of an erosion other than not being able to eat without it being a slider food or have so much mayo, gravy or ranch added that it defeats the purpose.If i had not gone to have it completely removed then where would i be right now? would i even "be" right now? this band has got to be removed from the market for the safety of the consumer.I know people who are surviving on ice cream and milkshakes alone because this is all that will go down.How healthy is that for someone? please do something about this before we have more fatalities with this band.Thank you for your time.

• Brand Name: LAPBAND
• Type of Device: LAPBAND
• Manufacturer (Section D): AP
• MDR Report Key: 3842881
• MDR Text Key: 4614138
• Report Number: MW5036369
• Device Sequence Number: 1
• Product Code: LTI
• 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: 05/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 6DRYD-51
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 135