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

Model Number 10-300

Device Problem Folded (2630)

Patient Problems Fatigue (1849); Pain (1994); Discomfort (2330)

Event Date 03/04/2014

Event Type  Injury  

Event Description

Forty seven year old female admitted for explantation of bilateral silicone implants on (b)(6) 2014.Past medical history: motion sickness, migraines, hiatal hernia, gastro reflux disease, breast cancer (multifocal lobular carcinoma in situ).Past surgical history: bilateral mastectomy's.(b)(6) 2013: exchange of tissue expanders for permanent breast implants bilaterally.Under specimens - 2 tissue expanders removed and discarded.Natrelle model #10-300, smooth silicone filled round moderate profile breast implants per operative report.Per nursing intra-op record - 2 tissue expanders removed and discarded.Right breast: mammary silicone natrelle 300cc, allergan usa inc.Serial # (b)(4).Left breast mammary silicone natrelle 300cc moderate profile, allergan usa inc.Serial # (b)(4).(b)(6) 2013: a report was filed with allergan, by a healthcare professional who reported left side "diffuse body edema, malaise, extreme weight gain, inability to sleep, extreme changes and fluctuations in blood pressure and asymmetrical density".A case file was opened up by allergan.Reference # (b)(4), catalog # 10-300, serial # (b)(4).(b)(6) 2013: mri of the breasts was completed to check for implant rupture.Mri revealed some what concerning configuration of the posterior wall of the right breast implant with what is possibly a prominent radial fold.It does appear to be asymmetric as compared to the left side.(b)(6) 2014: pt having systemic changes including diffuse muscle aching and tiredness.Chest discomfort and question of cerebrovascular accident symptoms all of which were proven to be negative.Removal of bilateral breast implants and mastectomy scar revision per operative note.Per nursing intra-op record-removal bilateral breast implants, revision of mastectomy scars, removal expander tissue breast.Under specimens- implants removed and discarded #1.

• Brand Name: NATRELLE SILICONE-FILLED BREAST IMPLANTS
• Type of Device: SILICONE BREAST IMPLANTS
• Manufacturer (Section D): ALLERGAN; po box 51470; ontario CA 91761 996
• MDR Report Key: 3736682
• MDR Text Key: 16012082
• Report Number: 3736682
• Device Sequence Number: 1
• Product Code: FTR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/01/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/01/2014
• Distributor Facility Aware Date: 03/25/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADD'L INFO TO #10 ABOVE: ONLY ONE IMPLANT RETURNED; TO COMPANY, THE OTHER WAS INADVERTENTLY DISCARDED.
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR