FDA Adverse Event Injury Summary report: N

HEYER-SCHULTE MFG.

MDR report key: 107866 · Received July 18, 1997

Report

Report Number
MW1011768
Event Type
Injury
Date Received
July 18, 1997
Date of Event
July 2, 1993
Report Date
July 17, 1997
Manufacturer
ALLEGIANCE HEALTHCARE CORP.
Product Code
FTR
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

"I IMPLORE YOU WITH ALL THAT IS DEAR HOLY & SACRED TO ME-BAN & REMOVE SILICONE BREAST/IMPLANTS FROM THE MARKET FOR ALL TIME SAKE. DOW; NEVER INVENTED A SAFE PRODUCT. FROM MY OWN EXPERIENCE & I WAS EXTREMELY CAUTIOUS, CAREFUL & TOOK EVERY MEASURE FOR 20 YRS. FOR MY BREASTS NEVER TO BE PINCHED OR MANIPULATED; NO ROUGH HOUSING; & FOR THOSE YEARS I WAS WELL, HAPPY & LENDING A NORMAL LIFE. I WAS TOLD THEY WOULD LAST A LIFE TIME, THEY WERE SAFE. BREAST CANCER COULD BE DETECTED & SO ON. HOWEVER, I WAS NOT TOLD HOW SICK I WOULD BECOME IF THE IMPLANTS WERE DAMAGED IN ANY WAY. WHAT THE DAMAGE: WHATEVER NAME, INJURY; RUPTURE, GEL BLEEDING, WOULD DO TO ME; MY HEALTH, & MOSTLY WHEN MY IMPLANTS WERE MUTILATED BY A MAMMOGRAM TECH DURING MAMMOGRAPHY-THIS CAUSED ME MY LIFE. MY ONCE WELL, HEALTHY & HAPPY LIFE ENDED IN THE MAMMOGRAM ROOM JULY 2, 1993. I HAVE ALOT TO SAY, BECAUSE I AM NEVER EVER FORGET EVER THE PAIN I ENDURED; THE AGONY I SUFFERED IN MY BREASTS , & CHEST PAIN, WHICH THEREAFTER LED TO MANY COMPLICATED MED CONDITIONS. THROW AWAY THE MOLD & I SAY-DOWN WITH DOW! I AM NOT WRITING THIS & NO MATTER WHO I TOLD THE REAL FACTS OF THE MATTER, FOR MY OWN FINANCIAL GAIN-I WANT OTHER WOMEN TO KNOW WHAT CAN HAPPEN & WHAT DID HAPPEN TO ME BECAUSE OF SEVERE DAMAGE TO MY SILICONE BREAST IMPLANTS. THERE IS NO AMOUNT OF MONEY TO GIVE ME BACK MY GOOD HLTH. I CERTAINLY DISPUTE THE MED JOURNALS. I CARRIED A DEFORMITY OF BOTH BREASTS. LEFT BREAST: HARD AS A BOULDER IN MY LEFT BREAST AND BIG AS A WATER MELON. I COULDN'T WALK & THE PAIN! I COULD NOT BEAR THE PAIN. "AGONY!" I DON'T WANT OTHER WOMEN TO GO THROUGH WHAT I WENT THROUGH. ONCE A JET SETTER; NOW A TORMENTED SOUL. MY ENGAGEMENT ENDED; I NO LONGER COULD WORK. JUST SICK! WHAT HURTS ME MOSTLY AFTER ALL IS SAID & DONE; BUT DOESN'T SURPRISE THE HOSP STATES THE INCIDENT NEVER OCCURRED. THEY LIE, LIE, LIE! I HAVE PHOTOS OF MY CHEST, AFTER THAT MAMMOGRAM THAT TELL A DIFFERENT STORY & SO DOES MY DR. PLEASE ALERT ALL WOMEN & FOREVER BAN SILICONE BREAST IMPLANTS. THERE WAS ONE PARTICULAR DR I SAW JAN '95 WHO TRIED TO HELP ME THE MOST. HE KEPT PICTURES OF ME BEFORE & AFTER IN HIS FILE. MY CARDIOLGOIST SAID "A" TERRIBLE THING HAPPENED TO ME. I THINK IT WAS MY OTHER CARDIOLOGITS, WHO ALSO SAID HE NEVER "SAW" ANYTHING LIKE MY CHEST. CARDIOLOGIST TOLD ME-I WAS A COMPLICATED MED CASE & REFERRED ME TO AN INTERNIST. THE LIST OF DRS GOES ON & ON AND THE INCIDENT ON 7/2/93, TOOK PLACE IN THE MAMMOGRAM ROOM. I WAS THERE THAT FRI 7/2/93 FROM APPROX 1:30 PM TO 5:00 OM. THE HOSP TIME IN SHEET CAN CLEARLY GIVE THE NAMES OF THE MAMMOGRAM TECH WHO WERE WOKING THERE THAT AFTERNOON & THE DRS ON DUTY. ALSO THE ALFTERNOON THE NAME OF THE BLONDE FEMALE DR, STOCKY, IN UNIFORM, 5 FT 5" OR 5 FT 6", ABOUT 155 LBS WHO TOLD ME AFTER 4 HRS OF PICTURE TAKING YOUR BREAST IMPLANTS HAVE JUST BEEN RUPTURES & WALKED OUT OF THE ROOM. AT 5:00 PM I WAS TOLD TO LEAVE. THIS SAME DR DISCHARGED ME & LEFT ME TO SUFFER THE CONSEQUENCES."

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 HEYER-SCHULTE MFG. Implant SILICONE BREAST IMPLANTS FTR ALLEGIANCE HEALTHCARE CORP. * I.D.#71004

Patients

Seq Age Sex Outcome Treatment
1 62 YR Hospitalization| L| R| S