MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 20 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	20-280
Medical Device Problem Codes	Material Rupture (1546); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.A review of the device history record has been completed.No deviations or non-conformances noted.The events of "silicone migration, pain, and capsular contracture" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: rupture, pain, and capsular contracture, baker grade iii.
Event or Problem Description
Patient reported left side "severe rupture", "device exploded," "lumps discovered to be gel escaping out of the body," and "because of the pain, device removed.They felt like they were having a heart attack, that's how bad it was hurting." additionally, healthcare professional reported capsular contracture, baker grade iii, "chest pain," and "breast pain." patient also reported "sick as a freaking dog," "thyroid on fire," "horrible rashes all over their legs"; these are not device related.Healthcare professional also reported "fatigue, cold/heat intolerance, low libido, numbness/tingling, cold hands/feet, night sweats, hormone imbalance, sob, joint pain/soreness, brain fog/memory loss, leg swelling/pain, dry skin/mouth/eyes, breast fibroids, food allergies, panic attacks, significant weight gain/loss"; these are not device related.Device has been explanted and discarded after surgery.

• Brand Name: STYLE 20 SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 9642374
• Report Number: 9617229-2019-23662
• Device Sequence Number: 11307581
• Product Code: FTR
• UDI-Device Identifier: 10888628001657
• UDI-Public: 10888628001657
• Combination Product (Y/N): N
• Initial Reporter State: UT
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/29/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/18/2020
• Device Model Number: 20-280
• Device Catalogue Number: 20-280
• Device Lot Number: 2845675
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR