MAUDE Adverse Event Report: ALLERGAN ALLERGAN 133FV; EXPANDER, SKIN, INFLATABLE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Arthritis (1723); Fatigue (1849); Fever (1858); Hair Loss (1877); Unspecified Infection (1930); Inflammation (1932); Memory Loss/Impairment (1958); Pain (1994); Loss of Range of Motion (2032); Rash (2033); Seroma (2069); Swollen Lymph Nodes (2093); Arthralgia (2355)

Event Date 10/26/2015

Event Type  Injury  

Event Description

I was diagnosed with breast cancer.My plastic surgeon used allergan 133fv tissue expander to hold my shape until implants could be used.I was told to undergo radiation with these in.This caused me severe contraction of the breast and extreme pain and problems that i still have today with the use of my arm.The info that i was never given by the surgeon was that it was a contraindication to use these for radiation therapy.I ended up with seromas and infections with a high fever.These were taken out and replaced for permanent implants but had to have those removed also.I am still having issues with my arms, skin, rashes and range of motion and pain to this day.I also have enlarged lymph nodes throughout my chest and abdomen to my pelvis i have chronic fatigue and have inflammation arthritis or rheumatoid arthritis.I have joint pain, my eyes and vision have changed.I get sick easily.I have memory and focus issues.I cannot work full time because i cannot keep up.I cannot keep up with my children and my home.I have lost some hair in patches.I am not the same person medically since these were placed into my body.It was confirmed that i have grade 4 capsular contractures.Fda safety report id# (b)(4).

• Brand Name: ALLERGAN 133FV
• Type of Device: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 8838434
• MDR Text Key: 152751428
• Report Number: MW5088447
• Device Sequence Number: 0
• Product Code: LCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/24/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 40 YR
• Patient Weight: 82