BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLY-L-LACTIC ACID

    MDR report key: 2503754 · Received March 22, 2012

    Report

    Report Number
    3002807108-2012-18315
    Event Type
    Injury
    Date Received
    March 22, 2012
    Report Date
    March 22, 2012
    Manufacturer
    AVENTIS PHARMA GRUPPO LEPETIT S.R.L.
    Product Code
    LMH
    PMA / PMN Number
    P030050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS ISSUED IN A PUBLICATION IN WHICH 1 OTHER CASE WAS REPORTED WITH SANOFI ID: (B)(4). THIS UNSOLICITED LITERATURE CASE WAS IDENTIFIED ON 13 MARCH 2012 VIA AN ARTICLE: BEER K. CLINICOPATHOLOGIC CORRELATION OF DELAYED-ONSET PERIORBITAL POLY-L-LACTIC ACID NODULES. DERMATOLOGIC SURGERY 2009; 35(1) :399-402. THIS CASE CONCERNS A (B)(6) FEMALE PT (PT NO 2) WHO EXPERIENCED DELAYED ONSET PERIORBITAL POLY-L-LACTIC ACID NODULES AFTER RECEIVING THERAPY WITH POLY-L-LACTIC ACID, TAKEN FOR FACIAL REJUVENATION. ON AN UNK DATE, THE PT WAS INJECTED WITH POLY-L-LACTIC ACID DILUTED WITH 4ML OF STERILE WATER AND 2ML OF 1% LIDOCAINE WITH 1:100,000 EPINEPHRINE. ONE BOTTLE OF PRODUCT WAS INJECTED INTO HER CHEEKS, TEAR TROUGHS, AND ZYGOMATIC ARCH AREAS. THE AMOUNT INJECTED INTO THE TEAR TROUGH AREA WAS APPROX 1ML ON EACH SIDE. A DEPOT INJECTION TECHNIQUE AT THE PERIOSTEAL LEVEL WAS USED, WITH DEEP MESSAGE PERFORMED AFTER INJECTION. SHE HAD A REPEAT INJECTION OF PRODUCT APPROX 1 MONTH AFTER HER FIRST INJECTION, USING AN IDENTICAL PROTOCOL. EIGHTEEN MONTHS AFTER HER LAST INJECTION, SHE DEVELOPED LUMPS ON HER FACE. ONE OF THESE, LOCATED ON HER LEFT INFERIOR ORBITAL RIM, WAS SURGICALLY EXCISED TO ENSURE THAT IT WAS NOT A SUBCUTANEOUS NEOPLASM. HISTOPATHOLOGIC EVAL REVEALED A DENSE FOREIGN BODY REACTION WITH ABUNDANT FORMATION OF COLLAGEN. TREATMENT WAS ADMINISTERED WITH INJECTIONS OF TRIAMCINOLONE ACETONIDE 10 MG/ML WITH GRADUAL IMPROVEMENT NOTED AFTER TWO INJECTIONS. THE EVENT OF DELAYED ONSET PERIORBITAL POLY-L-LACTIC ACID NODULES WAS RECOVERING. THE PT HAD UNDERGONE SKIN COSMETIC PROCEDURE IN THE PAST. THE PT HAD WATER (STERILE WATER), LIDOCAINE AND EPINEPHRINE AS DILUENT FOR THE MEDICATION (POLY-L-LACTIC ACID) CONCOMITANTLY. THE PT HAD INJECTIONS OF HYALURONIC ACID AND DURAPATITE (CALCIUM HYDROXYLAPATITE) IN THE PAST FOR SKIN COSMETIC PROCEDURES. THE AUTHOR CONCLUDED THAT THE FORMATION OF NODULES HAS BEEN A POTENTIAL COMPLICATION OF POLY-L-LACTIC ACID INJECTIONS SINCE ITS INCEPTION AS A COLLAGEN STIMULATOR. IT WAS ALSO STATED THAT THE PT DID NOT HAVE CLINICAL OR HISTOPATHOLOGIC SIGNS OF INFECTION, AND IT IS HIGHLY UNLIKELY THAT THIS WOULD HAVE PLAYED AN ETIOLOGIC ROLE IN THE FORMATION OF THE NODULES SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLY-L-LACTIC ACID FACIAL FILLER LMH AVENTIS PHARMA GRUPPO LEPETIT S.R.L. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other INJECTION (CON.)| EPINEPHRINE (CON.) UNK| WATER FOR UNK| LIDOCAINE (CON.) UNK| HYALURONIC ACID (PREV.) UNK| HYDROXYAPATITE (PREV.) UNK