BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTIVA IMPLANTS

    MDR report key: 21858265 · Received April 17, 2025

    Report

    Report Number
    3012883202-2025-00591
    Event Type
    Injury
    Date Received
    April 17, 2025
    Report Date
    April 17, 2025
    Manufacturer
    ESTABLISHMENT LABS S.A.
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    QUALITY DEPARTMENT (PMS) HAS RECEIVED A COMPLAINT REGARDING A DEVICE FROM ESTABLISHMENT LABS, ADDITIONAL INFORMATION PROVIDED IN THE "DETAILS" SECTION. FOR THE SUPPLEMENTAL REPORT, MULTIPLE ATTEMPTS WERE MADE TO COLLECT INFORMATION RELATED TO THE CASE, INCLUDING CLINICAL EVIDENCE, EVENT DETAILS, AND A DESCRIPTION OF THE DEVICE, IN ORDER TO CONDUCT AN APPROPRIATE INVESTIGATION. HOWEVER, NO ADDITIONAL INFORMATION WAS RECEIVED. AS A RESULT, IT WAS NOT POSSIBLE TO CONFIRM THE ALLEGED EVENT. DHR REVIEW: AFTER PERFORMING INITIAL REPORT IT WAS INDICATED THAT LOTS INVOLVED FOR THIS EVENT WERE 18055229/1902604, A COMPLETE REVIEW OF THE DHR WAS CARRIED OUT, NO DEVIATION WAS FOUND IN THE MANUFACTURING PROCESS. ADDITIONALLY, THE REVIEW OF COMPLAINT HISTORY FOR THE REPORTED LOT NUMBER AND STERILIZATION RUN FOUND NO OTHER SIMILAR COMPLAINTS REPORTED IN THE PAST. DFU REVIEW: -THE INSTRUCTIONS FOR USE IN THE DIRECTIONS FOR USE WERE REVIEWED, TO DETERMINATE IF THERE ARE INDICATIONS THAT ENSURE THE PREVENTION AND GOOD HANDLING OF THE PRODUCT. FOR THIS EVENT, IT IS CONSIDERED THAT THE INFORMATION IS SUITABLE FOR THE SECTION OF SURGICAL PRECAUTIONS AS FOLLOWS: CONNECTIVE TISSUE DISEASE (CTD) ¿ SINCE THE EARLY 1990S, NEARLY A DOZEN COMPREHENSIVE SYSTEMIC REVIEWS HAVE BEEN COMMISSIONED BY GOVERNMENT HEALTH MINISTRIES IN SEVERAL COUNTRIES TO EXAMINE THE ALLEGED LINKS BETWEEN SILICONE-GEL BREAST IMPLANTS AND SYSTEMIC DISEASES25. NO HARD EVIDENCE HAS BEEN FOUND TO SUPPORT AN ASSOCIATION BETWEEN SILICONE BREAST IMPLANTS AND CTDS. CASE REPORTS OF WOMEN WITH SILICONE BREAST IMPLANTS AND CTD INCLUDE THE FOLLOWING SYMPTOMS: NERVOUS SYSTEM ALTERATIONS (E.G., BRAIN FOG, MEMORY LOSS, BLURRED VISION, MIGRAINES, TINNITUS); MUSCULOSKELETAL DISEASE (E.G., MUSCLE/JOINT PAIN, FIBROMYALGIA, NUMBNESS/TINGLING IN UPPER AND LOWER LIMBS, AND SLOW MUSCLE RECOVERY AFTER ACTIVITY); IMMUNE/INFLAMMATORY (E.G., RAYNAUD SYNDROME, SJOGREN¿S SYNDROME, HASHIMOTO¿S THYROIDITIS, SCLERODERMA, RECURRENT/PERSISTENT INFECTIONS, AND RHEUMATOID ARTHRITIS); GI/GENITOURINARY (E.G., REDUCED LIBIDO, PANCREATITIS, URINARY TRACT INFECTION, METALLIC TASTE, CHOKING, SUDDEN DISEASE, ACID REFLUX, GASTRITIS, AND WEIGHT LOSS/GAIN); AS WELL AS CARDIORESPIRATORY AND PSYCHOLOGICAL SYMPTOMS. RECENT STUDIES STILL SUGGEST THAT THIS ASSOCIATION IS POSSIBLE, GIVEN THAT SILICONE IN BREAST IMPLANTS CAN ACT AS A FOREIGN BODY THAT CAN ELICIT AN INFLAMMATORY RESPONSE. MICROSCOPIC PARTICLES OF SILICONE FROM THE ORIGINAL SURGICAL SITE HAVE BEEN FOUND FAR AWAY FROM IT (E.G., IN THE LIVER), SUGGESTING A SMALL NUMBER OF SILICONE PARTICLES DETACH FROM THE IMPLANTS AND MIGRATE THROUGH THE LYMPHATIC OR CIRCULATORY SYSTEM TO OTHER ORGANS. IN THEORY, THEY COULD ACT AS ADJUVANTS AND START AN INFLAMMATORY PROCESS IN JOINTS OR ACTIVATE THE IMMUNE SYSTEM AND PER OUR DIRECTIONS FOR USE, EACH PATIENT MUST RECEIVE THE ESTABLISHMENT LABS S.A. ¿MOTIVA IMPLANTS®: INFORMATION FOR THE PATIENT¿ DURING HER SURGICAL CONSULTATION, IT IS THE SURGEONS´ RESPONSIBILITY TO ENSURE THAT THE PATIENT COMPLETELY UNDERSTANDS THE INFORMATION REGARDING THE RISKS, BENEFITS, AND RECOMMENDATIONS ASSOCIATED WITH SILICONE GEL-FILLED BREAST IMPLANT SURGERY, AS WELL AS THE COMPLICATIONS TYPICAL OF ANY TYPE OF SURGERY. THIS DOCUMENT IS AVAILABLE IN MOTIVA® WEBSITE: IFU.MOTIVA.HEALTH. AS STATED IN THE LITERATURE: HÖLMICH LR, LIPWORTH L, MCLAUGHLIN JK, FRIIS S. BREAST IMPLANT RUPTURE AND CONNECTIVE TISSUE DISEASE: A REVIEW OF THE LITERATURE. PLAST RECONSTR SURG. 2007;120(7 SUPPL. 1):62-69. DOI: 10.1097/01. PRS.0000286664.50274.F2. TREND REVIEW: ESTABLISHMENT LABS WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS/TRENDS. AS PART OF THE POST MARKET SURVEILLANCE PROCESS, MONITORING OF THE PRIMARY ENDPOINTS REPORTED IS PERFORMED TO DETERMINE UNFAVORABLE TRENDS. PER OUR CURRENT COMPLAINT DATA REPORT, NO UNFAVORABLE TRENDS WERE DETECTED ON THIS PRODUCT. NO FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    QUALITY DEPARTMENT (PMS) HAS RECEIVED A COMPLAINT REGARDING A DEVICE FROM ESTABLISHMENT LABS, ADDITIONAL INFORMATION PROVIDED IN THE "DETAILS" SECTION. SEVERAL COMMUNICATIONS TO COLLECT THE INFORMATION ON THE CASE (CLINICAL EVIDENCE, EVENT DETAILS AND DEVICE DESCRIPTION) AND CONDUCT AN APPROPRIATE INVESTIGATION OF THE COMPLAINT ARE BEING PERFORMED. DHR REVIEW: A COMPLETE REVIEW OF THE DHR FOR LOT INVOLVED COULD NOT BE CARRIED OUT, DUE TO NO LOT OR SERIAL NUMBER INVOLVED WAS PROVIDED. DFU REVIEW: THE INSTRUCTIONS FOR USE IN THE DIRECTIONS FOR USE WERE REVIEWED, TO DETERMINATE IF THERE ARE INDICATIONS THAT ENSURE THE PREVENTION AND GOOD HANDLING OF THE PRODUCT. FOR THIS EVENT, IT IS CONSIDERED THAT THE INFORMATION IS SUITABLE FOR THE SECTION OF SURGICAL PRECAUTIONS AS FOLLOWS: CONNECTIVE TISSUE DISEASE (CTD) ¿ SINCE THE EARLY 1990S, NEARLY A DOZEN COMPREHENSIVE SYSTEMIC REVIEWS HAVE BEEN COMMISSIONED BY GOVERNMENT HEALTH MINISTRIES IN SEVERAL COUNTRIES TO EXAMINE THE ALLEGED LINKS BETWEEN SILICONE-GEL BREAST IMPLANTS AND SYSTEMIC DISEASES25. NO HARD EVIDENCE HAS BEEN FOUND TO SUPPORT AN ASSOCIATION BETWEEN SILICONE BREAST IMPLANTS AND CTDS. CASE REPORTS OF WOMEN WITH SILICONE BREAST IMPLANTS AND CTD INCLUDE THE FOLLOWING SYMPTOMS: NERVOUS SYSTEM ALTERATIONS (E.G., BRAIN FOG, MEMORY LOSS, BLURRED VISION, MIGRAINES, TINNITUS); MUSCULOSKELETAL DISEASE (E.G., MUSCLE/JOINT PAIN, FIBROMYALGIA, NUMBNESS/TINGLING IN UPPER AND LOWER LIMBS, AND SLOW MUSCLE RECOVERY AFTER ACTIVITY); IMMUNE/INFLAMMATORY (E.G., RAYNAUD SYNDROME, SJOGREN¿S SYNDROME, HASHIMOTO¿S THYROIDITIS, SCLERODERMA, RECURRENT/PERSISTENT INFECTIONS, AND RHEUMATOID ARTHRITIS); GI/GENITOURINARY (E.G., REDUCED LIBIDO, PANCREATITIS, URINARY TRACT INFECTION, METALLIC TASTE, CHOKING, SUDDEN DISEASE, ACID REFLUX, GASTRITIS, AND WEIGHT LOSS/GAIN); AS WELL AS CARDIORESPIRATORY AND PSYCHOLOGICAL SYMPTOMS. RECENT STUDIES STILL SUGGEST THAT THIS ASSOCIATION IS POSSIBLE, GIVEN THAT SILICONE IN BREAST IMPLANTS CAN ACT AS A FOREIGN BODY THAT CAN ELICIT AN INFLAMMATORY RESPONSE. MICROSCOPIC PARTICLES OF SILICONE FROM THE ORIGINAL SURGICAL SITE HAVE BEEN FOUND FAR AWAY FROM IT (E.G., IN THE LIVER), SUGGESTING A SMALL NUMBER OF SILICONE PARTICLES DETACH FROM THE IMPLANTS AND MIGRATE THROUGH THE LYMPHATIC OR CIRCULATORY SYSTEM TO OTHER ORGANS. IN THEORY, THEY COULD ACT AS ADJUVANTS AND START AN INFLAMMATORY PROCESS IN JOINTS OR ACTIVATE THE IMMUNE SYSTEM AND PER OUR DIRECTIONS FOR USE, EACH PATIENT MUST RECEIVE THE ESTABLISHMENT LABS S.A. ¿MOTIVA IMPLANTS®: INFORMATION FOR THE PATIENT¿ DURING HER SURGICAL CONSULTATION, IT IS THE SURGEONS´ RESPONSIBILITY TO ENSURE THAT THE PATIENT COMPLETELY UNDERSTANDS THE INFORMATION REGARDING THE RISKS, BENEFITS, AND RECOMMENDATIONS ASSOCIATED WITH SILICONE GEL-FILLED BREAST IMPLANT SURGERY, AS WELL AS THE COMPLICATIONS TYPICAL OF ANY TYPE OF SURGERY. THIS DOCUMENT IS AVAILABLE IN MOTIVA® WEBSITE: IFU.MOTIVA.HEALTH. AS STATED IN THE LITERATURE: HÖLMICH LR, LIPWORTH L, MCLAUGHLIN JK, FRIIS S. BREAST IMPLANT RUPTURE AND CONNECTIVE TISSUE DISEASE: A REVIEW OF THE LITERATURE. PLAST RECONSTR SURG. 2007;120(7 SUPPL. 1):62-69. DOI: 10.1097/01. PRS.0000286664.50274.F2. TREND REVIEW: ESTABLISHMENT LABS WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS/TRENDS. AS PART OF THE POST MARKET SURVEILLANCE PROCESS, MONITORING OF THE PRIMARY ENDPOINTS REPORTED IS PERFORMED TO DETERMINE UNFAVORABLE TRENDS. PER OUR CURRENT COMPLAINT DATA REPORT, NO UNFAVORABLE TRENDS WERE DETECTED ON THIS PRODUCT. NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    TITLE: CONNECTIVE TISSUE DISEASE DESCRIPTION: IT WAS REPORTED THAT AFTER A SECONDARY AUGMENTATION IN 2020, THE PATIENT HAD THE FOLLOWING SYMPTOMS: NIGHT SWEATS, HAIR LOSS, FATIGUE, BRAIN FOG, PALPITATIONS (MOSTLY AT NIGHT), AND AMENORRHEA. THESE SYMPTOMS STARTED WHEN THE PATIENT HAD HER PREVIOUS IMPLANTS (MENTOR) IN 2017 BUT WORSENED AFTER THE CHANGE TO MOTIVA IN 2020. THE PATIENT HAD THE IMPLANTS REMOVED, AND THE SYMPTOMS ALMOST DISAPPEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1776768 MOTIVA IMPLANTS MOTIVA SMOOTHSILK ROUND AND ERGONOMIX BREAST IMPLANTS FTR ESTABLISHMENT LABS S.A. RSC-550+ 18055229

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization