MOTIVA SILKSURFACE PLUS WITH QID
Report
- Report Number
- 3012883202-2025-00492
- Event Type
- Injury
- Date Received
- March 19, 2025
- Report Date
- July 7, 2025
- Manufacturer
- ESTABLISHMENT LABS S.A.
- Product Code
- FTR
- UDI-DI
- 07445161002969
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
THE HUMAN IMMUNE SYSTEM IS A VERY HIGHLY REFINED MECHANISM OF DEFENSE. ALTHOUGH CHARGED WITH MOUNTING AN ANTIBODY RESPONSE TO ANY UNRECOGNIZED ANTIGEN THREAT, IT MUST ALSO POSSESS ENOUGH CHECKS AND BALANCES TO NOT CAUSE UNWARRANTED HOST-VERSUS-HOST REACTIONS. SILICONE EXISTS NATURALLY IN ALL MAMMALS. AN EXHAUSTIVE SEARCH OF THE LITERATURE SEEMS TO INDICATE THAT SILICONE, AS IT EXISTS IN THE CURRENT FORMS OF IMPLANTABLE BIOMEDICAL DEVICES INCLUDING BREAST IMPLANTS, IS AN IMMUNOLOGICALLY PRIVILEGED AND INERT MATERIAL. IT REMAINS INCUMBENT FOR THE MEDICAL PRACTITIONER, HOWEVER, TO CONSIDER AN IDIOSYNCRATIC REACTION AS A DIAGNOSIS OF EXCLUSION IN A DIFFERENTIAL DIAGNOSIS FOR AN INDIVIDUAL WITH A HISTORY OF A BIOIMPLANTABLE DEVICE AND AN UNUSUAL ALLERGIC RESPONSE BEGINNING AFTER DEVICE IMPLANTATION. APPROPRIATE CONFIRMATORY EVALUATION, INCLUDING PATCH TESTING, IS RECOMMENDED. IF THIS DIAGNOSIS IS SUPPORTED EXPLANTATION OF THE DEVICE IS CURATIVE.¿ (SKANDALAKIS, SHIFFMAN. BREAST AUGMENTATION: PRINCIPLES AND PRACTICE. 2009 SPRINGER-VERLAG BERLIN HEIDELBERG). 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. 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: 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 DISEASES. 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 STIMULATE AUTOANTIBODIES' PRODUCTION. NEVERTHELESS, NO CONCLUSIVE DATA IS AVAILABLE IN THIS REGARD. ALSO, A COMPLETE REVIEW OF THE DHR'S WAS CARRIED OUT, NO DEVIATION WAS FOUND IN THE PROCESS, SO IT IS ESTABLISHED THAT THERE IS NO EVIDENCE OF A RELATIONSHIP BETWEEN THE EVENT AND THE MANUFACTURING PROCESS.
GENERAL CONCLUSION: -EVENT ANALYSIS: CTD. AFTER AN ANALYSIS OF THE REPORT, IT WAS NOT POSSIBLE TO CONFIRM THE ALLEGED EVENT DUE TO NO CLINICAL EVIDENCE WAS PROVIDED. THE ALLEGED EVENT IS A RISK ASSOCIATED WITH BREAST SURGERY AND THERE IS NO EVIDENCE TO SUGGEST A LINK BETWEEN THIS PARTICULAR IMPLANT AND/OR ITS MANUFACTURING PROCESS AND A HIGHER RISK OF OCCURRENCE. THE CAUSE OF THIS EVENT IS MULTIFACTORIAL, AND WE CANNOT CONCLUDE THAT THE REPORTED EVENT WAS CAUSED BY THE MANUFACTURING PROCESS AND/OR THE PRODUCT ITSELF. DHR REVIEW: A COMPLETE REVIEW OF THE DHR FOR LOT INVOLVED WAS CARRIED OUT, NO DEVIATION WAS FOUND IN THE MANUFACTURING PROCESS. ADDITIONALLY, THERE WERE NO INDICATIONS OF ABNORMALITIES IN RAW MATERIALS OR MANUFACTURING PROCESSES WHICH MAY HAVE AFFECTED THIS PARTICULAR BATCH. 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.
IT WAS REPORTED THAT A PATIENT WHO WAS IMPLANTED ON (B)(6) 2022 WAS SUFFERING FROM EXTREME JOINT PAIN, WEIGHT LOSS, BRAIN FOG, AND ANXIETY. NO PATIENT DEMOGRAPHICS, SUCH AS AGE, WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER, AND NO ADVERSE OUTCOMES FOR THE PATIENT HAVE BEEN NOTED. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 457034 | MOTIVA SILKSURFACE PLUS WITH QID | MOTIVA IMPLANTS | FTR | ESTABLISHMENT LABS S.A. | 21061969 | 07445161002969 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |