MAUDE Adverse Event Report:; BILUMEN BREAST IMPLANTS

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problems Failure of Implant (1924); Seroma (2069); Abdominal Distention (2601)

Event Date 01/06/2015

Event Type  Injury  

Event Description

Failed bilateral silicone gel implants.Pt underwent bilateral mastectomies and breast reconstruction in 1992.At that time, pt had bilumen, adjustable implants implanted.Manufacturer is unk to providers and to pt.These implants were a combination of silicone and saline.Recent history noticed right side had deflated and the left side had enlarged.Pt underwent dissection on the right side exposing lateral border of the pectoralis muscle where capsule was entered, silicone was noted in the wound, and sent for culture due to brownish color, no other evidence of infection, residual free silicone within capsule removed and capsulectomy was done to remove as much of the silicone containing tissue as possible.Left side approached in same fashion and upon entering the capsule watery consistency to fluid which was chocolate brown color suggestive of old hemorrhage.Fluid suctioned and procedure proceeded and a subtotal capsulectomy was done on the left side.

• Brand Name: UNK
• Type of Device: BILUMEN BREAST IMPLANTS
• MDR Report Key: 4465694
• MDR Text Key: 17631184
• Report Number: 4465694
• 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: 01/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/19/2015
• Distributor Facility Aware Date: 01/06/2015
• Device Age: 23 YR
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 78