FDA Adverse Event Injury Summary report: N

MCGHAN 310 CC

MDR report key: 6940142 · Received October 11, 2017

Report

Report Number
MW5072670
Event Type
Injury
Date Received
October 11, 2017
Date of Event
July 31, 2017
Report Date
October 9, 2017
Manufacturer
ALLERGAN
Product Code
FWM
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
NC, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I WAS LEFT UNDIAGNOSED BY 5 HEALTH CARE PROFESSIONALS INCLUDING MY ONCOLOGIST AND A PLASTIC SURGEON, AND TWO IMAGING COMPANIES AFTER PRESENTING TO THEM WITH IMPLANT ENLARGEMENT, PAIN, FULL OF FLUID, AND MISSHAPEN. FIFTEEN MONTHS WENT BY AND FINALLY I HAD MY MASTECTOMY, IMPLANT REMOVED AFTER BEING TOLD BY MY ONCOLOGIST THAT MY SALINE IMPLANT HAD RUPTURED (MISDIAGNOSIS, NOT EVEN A GOOD GUESS). THE RESULTING BIOPSY OF THE REMOVED OLD IMPLANT SHOWED ALCL. I HAD THE NEW IMPLANT REMOVED SOON AFTER AND THE SURGEON FOUND PART OF MY RIBS GONE. I ELECTED TO HAVE A PROPHYLACTIC MASTECTOMY ON THE OTHER SIDE AT THE TIME OF REMOVING THE NEW IMPLANT. I WAS CLOSED UP WITHOUT ESTHETICS BECAUSE I WILL NEED THORACIC RECONSTRUCTION AFTER UNDERGOING CHOP CHEMOTHERAPY. ALL OF THIS COULD HAVE BEEN AVOIDED IF: MY ORIGINAL PLASTIC SURGEON HAD MONITORED ME OVER THE YEARS AND CAUTIONED ME THAT OLD IMPLANTS NEED TO BE REDONE; MY ONCOLOGIST WOULD HAVE KNOWN THE SYMPTOMS TO BE A SIGN OF ALCL; A PLASTIC SURGEON TO WHOM I WENT FOR CONSULTATION WOULD HAVE KNOWN THE SYMPTOMS TO BE A SIGN OF ALCL; THE TWO DIFFERENT IMAGING COMPANIES AND SUBSEQUENT DOCTORS WHO WITHDREW FLUID AROUND THE IMPLANT WOULD HAVE KNOWN THE SYMPTOMS TO BE A SIGN OF ALCL; OR THE ONCOLOGIST SENT ME TO THE URGENT CARE FACILITY (I KNEW IT TO BE A MISTAKE, BUT I WENT ANYWAY) AND THE PHYSICIAN THERE WOULD KNOW THAT PAIN WAS A SIGN OF ALCL. SO THERE ARE FIVE MEDICAL PRACTITIONERS WHO KNEW NOTHING OF FINDING CANCER IN IMPLANTS. SOMEHOW ALL OF THESE DOCTORS MUST BE MADE AWARE THAT IF A WOMAN PRESENTS WITH THESE FOUR SYMPTOMS WITH AN IMPLANT THAT STEPS SHOULD BE TAKEN ASAP TO PERHAPS REMOVE THE CAPSULE EITHER BEFORE THE ALCL HAS DEVELOPED, OR CERTAINLY BEFORE THE ALCL HAS INVADED THE THORACIC CAVITY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
719940 MCGHAN 310 CC SALINE IMPLANT FWM ALLERGAN NA NA

Patients

Seq Age Sex Outcome Treatment
1 73 YR Hospitalization| L| O| R