FDA Adverse Event Injury Summary report: N

RESTYLANE

MDR report key: 1274203 · Received December 16, 2008

Report

Report Number
MW5009356
Event Type
Injury
Date Received
December 16, 2008
Date of Event
December 6, 2006
Report Date
November 10, 2008
Manufacturer
MEDICIS AESTHETICS INC.
Product Code
LMH
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I WENT TO DR IN LATE 2006 REGARDING AN ACNE SCARS BY MY EAR, THE DOCTOR SUGGESTED A PRODUCT CALLED "RESTYLANE". HIS FOCUS SUDDENLY WENT FROM MY EAR SCAR TO MY FACE TELLING ME MY LAUGH LINES MAKE ME LOOK OLD, HE KEPT REPEATING HIMSELF AND THAT'S WHERE HE INJECTED THE RESTYLANE. I HAD PAIN FOLLOWED BY LUMPS; THEY DID NOT REDUCE IN SIZE. I CALLED DR. ABERGEL SEVERAL TIMES IN THE FOLLOWING DAYS, MONTHS AND EVEN AFTER A YEAR ABOUT THE LUMPS AND DR HAD NO ANSWERS OR REMEDY FOR ME. HE REFUSES TO TAKE ANY RESPONSIBILITY FOR HIS WORK AND HAS ONLY GIVEN ME A REFUND AND SENT ME A LETTER THROUGH HIS ATTORNEY NOT CONTACT HIM AGAIN. THIS DOCTOR NEVER SHOWED ME THE RESTYLANE PACKAGE OR THE DOSAGE HE INJECTED. IT IS NOW ALMOST TWO YEARS THIS INJECTION HAS LEFT TWO LUMPS LIKE JELLY INFLAMED IN THE SIDES OF MY MOUTH (SEE PICTURES) AND HAS CHANGED THE CONTOUR OF MY FACE; IT LOOKS PERMANENT AS THEY HAVE NOT REDUCED MUCH IN SIZE. I CAN ONLY ASSUME IS THE PRODUCT "RESTYLANE" SINCE IT IS WHAT THE DR CLAIMS HE INJECTED. I AM VERY WORRIED AS IT MAY NOW TAKE SURGERY TO GET THIS STUFF OUT OF MY SKIN? I HAVE MADE TWO MORE APPOINTMENTS IN THE NEXT COMING MONTHS TO SEE A DERMATOLOGIST DOCTOR AND ANOTHER PLASTIC SURGEON TO FIND A REMEDY AND SOLUTION AND REMOVE THESE LUMPS BECAUSE THEY LOOK LIKE PERMANENT. I ALSO WANT TO ADD THAT I ALSO CALLED THE COMPANY RESTYLANE BUT THERE WAS NOT MUCH OF HELP TO ME AND STATED WHAT MY REACTION IS VERY RARE. I AM SORRY IF MY COMPLAINT SEEMS MORE ABOUT DR THAN THE PRODUCT "RESTYLANE" AND I ALREADY CALLED AND SPOKE TO ONE OF YOUR AGENTS AND EXPLAINED MY SITUATION. I HAVE HAD A LOT OF PROBLEMS COMMUNICATING WITH DR ABOUT THE SIDE EFFECTS OF THIS PRODUCT WHICH HE NEVER SPENT ANY TIME EXPLAINING WHAT ARE THE SIDE EFFECTS, AS HE WAS MORE CONCERNED TO GET MY CREDIT CARDS. I THINK A DOCTOR SHOULD ALWAYS EXPLAIN THE PRO AND CONS OF ANY PRODUCT THEY ARE USING. I HAVE ALREADY REPORTED HIM TO THE MEDICAL STATE BOARD AND BECAUSE I HAD SIGNED SOME CONSENT FORM THERE WAS NOT MUCH THE STATE BOARD COULD DO EITHER. MEANWHILE I STILL HAVE THESE LUMPS AND I MAY SPEND MORE MONEY ON SURGERY TO REMOVE OR FIND SOME SOLUTION TO RESOLVE THIS AND THERE HAS TO BE A SOLUTION AND THAT IS ALL I SEEK AND I HOPE TO PREVENT THIS TO HAPPEN AGAIN TO SOMEONE ELSE. I WOULD ALSO LIKE TO KNOW IF THE COMPANY MEDICIS ANESTHETICS INC WHO MAKES RESTYLANE IS WILLING TO OFFER ANY HELP OR COMPENSATION FOR THIS SIDE EFFECT OF THEIR PRODUCT, AND TRUST ME I AM NOT HERE TO SUE ANYONE OR MAKE MONEY BUT I JUST WANT HELP FOR MY FACE TO GO BACK TO NORMAL AGAIN. I THANK YOU FOR YOUR HELP. DATES OF USE: 2006. DOSE OR AMOUNT: ASK DR DIAGNOSIS OR REASON FOR USE: COSMETIC INJECTION FOR LINES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 RESTYLANE NONE LMH MEDICIS AESTHETICS INC. 79911

Patients

Seq Age Sex Outcome Treatment
1 41 YR Other| R