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

Device Problems Material Separation (1562); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Abdominal Pain (1685); Failure of Implant (1924); Nausea (1970); Vomiting (2144); Obstruction/Occlusion (2422); Sleep Dysfunction (2517)

Event Date 07/18/2022

Event Type  Injury  

Event Description

I first experienced a sharp upper abdominal pain while sitting watching tv on the evening of (b)(6) 2022.The pain was intermittent and seemed either aggravated or relieved depending on how i moved in the seated position.I eventually went to bed and woke up to more generalized, stabbing abdominal pain.I had trouble getting up and down stairs as the pain grew worse.After about an hour i drove myself to the emergency room of my local hospital, where i sat for the next 9 hours.Lab work and ct scan failed to confirm what medical personnel were seeking (i.E.Confirmation of any medical hypotheses at that time, such as appendicitis, diverticulitis, etc).I was discharged and sent home with a prescription for protonix and told to return if the pain got worse.A couple of hours later, after a light meal, the pain returned in full force and i returned to the hospital emergency room, this time going to a larger, better resourced hospital in an adjacent state, which was under the same administrative umbrella as hospital #1).I was in this hospital's emergency room for approximately 12 hours.Labs and ct scan report from hospital #1 were reviewed and i was seen by a small team of medical professionals from hospital #2's bariatric department.Both hospital #1 and hospital #2's professionals noted that my gastric lap band, which was approximately 12 years old, had " become discontinuous" ( i.E.The top, or port, had become separated from the bottom, or hosing/tubing).They were unsure if this disconnection was causing the excruciating pain i had been experiencing since the evening before.I was in such pain that morphine was administered twice during my stay in the emergency room.Failing to confirm any pathology/illness, however, i was discharged & instructed to follow up with my pcp (primary care provider) and my lap band specialist who had provided after-care since i'd had the lap band installed, which i did.I continued to suffer with incredible stabbing pain, could not eat or sleep for weeks until surgery on (b)(6) 2022, which relieved the stabbing pain ( and which confirmed that it was the disconnection of the malfunctioning band that had caused the pain), but i had a new problem post-surgery: debilitating nausea and continuous vomiting.I was instructed to return to the emergency room, this time to a third hospital, hospital #3, where my lap band doctor practices.A scan there indicated an intestinal obstruction, caused by the bowel getting caught in an incisional hernia that developed after the surgery he'd performed a week earlier, to remove the band.I experienced immediate relief from nausea and vomiting after the second surgery to free the bowel.I had suffered so much for so many weeks and had endured the risks of two exposures to general anesthesia twice in one week and could have faced even greater medical problems (e.G.A punctured bowel, sepsis, etc) had the condition leading from the malfunctioning lap band continued.I had visited 3 different emergency room's and was hospitalized for 4 days.I was sick for more than two months with extreme pain, nausea, and then with recovery from surgeries.I would never recommend the use of this product to anyone.The band was manufactured by allergan and may no longer be made.However, there are similar products being inserted into patients today that i hope the fda is monitoring for these potential problems.Model, catalog, lot, serial, and udi numbers: unknown.Fda safety report id # (b)(4).

• Brand Name: GASTRIC LAP BAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN; 2525 dupont dr.; irvine CA 92612
• MDR Report Key: 15690678
• MDR Text Key: 302784113
• Report Number: MW5112940
• 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: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2022
• Patient Sequence Number: 1
• Treatment: CALCIUM, MAGNESIUM, PRILOSEC.; METROPOLOL, CANDESARTAN. PROTONIX, MORPHINE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Hispanic
• Patient Race: White