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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN LAP BAND

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ALLERGAN LAP BAND Back to Search Results
Device Problems Material Erosion (1214); Malposition of Device (2616)
Patient Problems Bacterial Infection (1735); Fever (1858); Hair Loss (1877); Pain (1994); Increased Sensitivity (2065); Tachycardia (2095); Scar Excision (2358); Inadequate Pain Relief (2388)
Event Date 02/10/2009
Event Type  Injury  
Event Description
I had an allergan lap band installed in (b)(6) of 2009 with tlc edge in (b)(6).I used dr (b)(6) in (b)(6) and the band was installed with an outpatient procedure.The doctor cancelled my pre surgery appt the day of the appt when i was on my way to (b)(6) from (b)(6).I still went ahead with the procedure and was back home in my own bed four hours after surgery.I live about three hours from where the surgery was done.I lost weight.I went from (b)(6) immediately and then over time, i lost another twenty pounds and made it down to (b)(6).Fast forward to 2013.I was diagnosed with a diseased gall bladder.I had 8cc in a 10cc band.I had asked at my last fill in 2011 when i needed to return for a checkup.I was advised to return when i needed a fill.This was from the person that did my fill.I never saw dr (b)(6) before or after the day of surgery.I was either channeled through his p.A.Or the tech that did the fills.I was never advised to come in before any other type of surgery.I had no problems with my band other than the rare instance that a piece of food got stuck and that didn't last very long as i was never fully filled.I had my gall bladder removed in (b)(6) of 2013 at my local hospital in (b)(6).My surgeon was advised that i had a lap band at our first appointment.I went home, took a nap and felt well enough that my husband and i went to a movie that evening.Three days after surgery i started running a fever.Over the next three weeks i returned to the surgeons office and the emergency room of my local hospital.I was given iv fluids and a short course of cipro and told to force myself to eat.My wbc was down twice prior to surgery and was on the low side of normal.It started climbing and was way out of normal range before a cat scan was done that showed i had developed a massive abdominal infection.I was advised to return to my (b)(6) in (b)(6).As usual he was not available to see me but i was referred to an excellent surgeon, dr (b)(6).This man saved my life.I spent the next seven weeks in (b)(6) and (b)(6).I had a weeks worth of antibiotics before they opened me up and removed the band and flushed my abdominal cavity of all the putrid material that had filled me up.I was left to heal open with a wound vac, that was a five week process that was extremely painful and disgusting.My band had eroded 75 percent into my stomach and i had sepsis.My heart rate went through the roof and if the infection had crossed into my pericardium, i would have died.I was told another day without medical intervention would have cost me my life.My medical bills totaled over (b)(6).My insurer refused to pay any part because of the involvement of the lap band.My husband's insurer paid the bills and was able to negotiate them down to (b)(6).I am left with a damaged stomach and an eight inch scar.I was told the band was not in the proper position, i don't know if that was ever put into medical records.Dr (b)(6) came to see me once over a weekend when he was doing rounds for dr (b)(6).I took antibiotics so strong that my hair fell out and changed texture when it grew back in.The scar is sensitive and i cannot wear clothing that comes into close contact with my scar.It extends from my belly button to just under my breast bone.Due to it healing open, it is particularly ugly.Months after this ordeal, dr (b)(6) office contacted me wanting to know if i still had my band, the man is clueless and greedy, a dangerous combination.I was hospitalized from (b)(6) 2013 until (b)(6) 2013.Seven and a half of the longest weeks of my life.I was advised in 2009 that the band had a 1 percent failure rate.That was a lie.I was told that the band was a permanent weight loss option.That was a lie.I was also told the band was the least invasive method of (b)(6) and fully reversible.Lies.
 
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Brand Name
LAP BAND
Type of Device
LAP BAND
Manufacturer (Section D)
ALLERGAN
MDR Report Key4924485
MDR Text Key17219169
Report NumberMW5044410
Device Sequence Number1
Product Code LTI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/13/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Patient Sequence Number1
Treatment
VITAMIN AND MINERAL SUPPLEMENT; GARCIA CAMBOGIA; BIOTIN; ALEVE AS NEEDED; VITAMIN D; LEVOTHYROXIN; LISINOPRIL; IRON SUPPLEMENT; TYLENOL AS NEEDED
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age48 YR
Patient Weight90
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