MAUDE Adverse Event Report: LIFECELL CORPORATION / ALLERGAN STRATTICE ACCELULAR DERMAL MATTRIX ; MESH, SURGICAL

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Cellulitis (1768); Purulent Discharge (1812); Deformity/ Disfigurement (2360); Impaired Healing (2378)

Event Date 09/14/2019

Event Type  Injury  

Event Description

One year after receiving allergan smooth implants along with lifecell (allergan) strattice, an abscess formed on my right breast incision.I ended up in the er, labs were drawn and a culture was taken of the abscess fluid.I was put in an antibiotic.Within 24 hours my incision started to open; 24 hours later, my implant and unincorporated strattice was exposed.I was out of town so had to see a plastic surgeon there.He identified the strattice and removed the exposed strips.Within a week i saw my local ps and he removed the implant.Two days later an abscess appeared on my left implant incision.Two days later my left implant was removed.I had drain tubes that were removed in a couple days.Almost immediately i started to discharge a thick, green, mucous.All cultures from drainage and tissue and all blood tests showed no bacteria, no fungus, no inflammatory markers, etc.My incisions started to open again and eventually another hole formed through my right breast along the incision.For weeks i dealt with extreme discharge (changing bandages 8-10 times daily) and saw an infectious disease dr.Eventually my surgeon spoke to allergan rep and a decision was made to remove my breast tissue and hopefully any dermal matrix-strattice-cells that may have incorporated into my tissue.Drain tubes were left at the incision site and immediately after surgery the green discharge stopped.Drains were removed and the right breast healed well.Left breast got cellulitis and i was taken to the hosp where i received iv antibiotics, blood draw, culture of discharge from the cellulitis and an ultrasound.I was asked to stay in the hosp but instead decided to go to an infusion center every 12 hrs.The following day my infectious disease doc said no to iv antibiotics for fear of c-diff.Then the left incision started to open up again and eventually i had to go to wound care doc.He ordered me to complex care at the hosp for daily packing of my wound and bandage changes.On this date, (b)(6) 2019, i still have an open wound, packing material, am on antibiotics and don't feel like i'm healing.I now found out that my capsule was not completely removed because my ps said he needed it over my lungs.I fear the strattice is still left in my body and is causing this harm to me as well as the deformity of my breasts.All drs have verbally suspected the problem to be due to the adm.I was told by my surgeon's office that allergan had filed an adverse event with the fda.To date i don't see it posted to the fda site.Too many tests and cultures to name.All tissue cultures and blood tests and serum cultures came back normal.I had no infection, no fungus, no cancer.I was not sick and explanting or reacting to this product.This product was attacking me.My breasts are now deformed and won't heal.I've had two other sets of silicone implants and no issues until the strattice was put in my body.Fda safety report id# (b)(4).

• Brand Name: STRATTICE ACCELULAR DERMAL MATTRIX
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL CORPORATION / ALLERGAN
• MDR Report Key: 9437725
• MDR Text Key: 170096549
• Report Number: MW5091523
• Device Sequence Number: 1
• Product Code: FTM
• 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: 12/04/2019

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
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 59 YR
• Patient Weight: 47