FDA Adverse Event Injury Summary report: N

BREAST IMPLANT (FWM)

MDR report key: 1680385 · Received May 11, 2010

Report

Report Number
MW5015869
Event Type
Injury
Date Received
May 11, 2010
Date of Event
April 29, 2010
Report Date
May 11, 2010
Manufacturer
ALLERGAN
Product Code
FWM
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

PT HAD BREAST IMPLANT SURGERY IN 2005. THE SURGEON WHO PERFORMED THE SURGERY PASSED AWAY OR ELSE HE WOULD HAVE TAKEN CARE OF THIS PROBLEM. ON (B) (6) 2010, WHILE SHOWERING, PT NOTICED HER RIGHT BREAST DROOPING. PT'S RIGHT BREAST IMPLANT HAD DEFLATED (RUPTURED). THIS SCARED HER, THINKING THAT HER IMPLANT HAD BURST. PT HAD CONSULTATION ON THE (B) (6) 2010 AND CONFIRMED RUPTURE. WARRANTY WILL ONLY COVER ONE IMPLANT AND PT STILL HAS TO PAY (B) (4) OUT OF POCKET MINUS THE COST OF THE IMPLANT. THIS SHOULD NOT HAVE HAPPENED WITHIN 10 YEARS OF GETTING IMPLANT. WARRANTY SHOULD COVER BOTH BREASTS, IF ONE RUPTURED THEN IT IS ONLY A MATTER OF TIME UNTIL THE OTHER DOES. THIS CAUSING AN ADDITIONAL SURGERY, MORE MONEY AND TIME. AFTER SURGERY, PT WAS HANDED WARRANTY INFORMATION, NO ONE EXPLAINED THE DIFFERENCE IN WARRANTIES. NO ONE EXPLAINED THE IMPORTANCE OF HAVING THE BETTER, MORE EXPENSIVE WARRANTY TO COVER BOTH BREASTS. OTHER COMPANIES OFFER BOTH BREASTS COVERED AS A BASIC WARRANTY. ALLERGAN DOES NOT STAND BEHIND THEIR PRODUCT ENOUGH TO WARRANTY BOTH BREASTS, AND DOESN'T CARE ABOUT THE HEALTH OF WOMEN. ALL PTS SHOULD BE TOLD THAT THERE ARE TWO WARRANTIES AND THE PUBLIC SHOULD BE COVERED BY ALL MANUFACTURERS THE SAME. PATIENT FEELS INSECURE AND CANNOT BE INTIMATE. PT IS AFRAID AND KEEPS CHECKING OTHER BREAST. PT IS AFRAID THAT IT COULD RUPTURE ANYWHERE, ANYTIME. THIS IS EMBARRASSING AND PSYCHOLOGICALLY TRAUMATIC. PT IS UPSET AND DOESN'T WANT THIS TO HAPPEN TO ANY OTHER WOMEN. WHY SHOULD MANUFACTURERS GET AWAY WITH ONLY COVERING A CERTAIN AMOUNT?

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BREAST IMPLANT (FWM) FWM ALLERGAN 1086908

Patients

Seq Age Sex Outcome Treatment
1 47 YR Other