MAUDE Adverse Event Report: ALLERGAN NATRELLE SILICONE GEL FILLED; BREAST IMPLANTS

Catalog Number	45-700
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Codes	Abdominal Pain (1685); Autoimmune Disorder (1732); Cellulitis (1768); Erythema (1840); Fatigue (1849); Headache (1880); Hypersensitivity/Allergic reaction (1907); Pain (1994); Rash (2033); Skin Discoloration (2074); Skin Irritation (2076); Swelling (2091); Skin Inflammation (2443); Weight Changes (2607); Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	10/06/2008
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient with history of breast cancer and double mastectomy, reports complications with natrelle cohesive silicone breast implants.Patient decided to have breast reconstruction after her mastectomy in 2008.She states she did not want the cohesive implant, however the surgeon explained she would not be a candidate for saline breast implants due to reconstructive tissue.The patient was implanted with tissue expanders following her mastectomy.The left tissue expander ruptured during chemotherapy treatment, and was replaced with a new one.In (b)(6)2009, the patient had her breast implant procedure where she also implanted alloderm surgical mesh to hold implants in place.She states the left-sided mesh separated and was replaced with a new one.Over the last 8 years, patient states she experienced pain and periodic rashes around her armpits and implant area.She also had bulging, callous, and discoloration/irritation around the left breast and armpit.Patient had an mri done in (b)(6) 2016 and found the left breast implant had ruptured and the gel escaped from the scar capsule.The gel traveled to her lymphatic system into her lymph nodes on the right side of her body.The surgeon who implanted the device states the gel cannot travel and this event occurred from something else.The doctor was unable to remove the material due to expected lymphedema problems.Since the rupture patient states she has developed 3 auto-immune disease, including celiac disease, as well as cellulitis, weight loss, dermatitis, rosacea, microscopic colitis, occipital neuralgia, difficulty swallowing, stomach issues, headache, and fatigue.Patient reports she has developed sensitivity to smell, gluten, wheat, dairy, and antibiotics.

• Brand Name: NATRELLE SILICONE GEL FILLED
• Common Device Name: BREAST IMPLANTS
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 6249059
• Report Number: MW5067193
• Device Sequence Number: 12345358
• Product Code: FTR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 01/12/2017
• 8 Devices were Involved in the Event: 1 2 3 4 5 6 7 8

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 11/01/2013
• Device Catalogue Number: 45-700
• Device Lot Number: 14036204
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 35 YR
• Patient Weight: 54