MOTIVA IMPLANTS

Description of Event or Problem

DURING MY IMPLANT CHANGE ON (B)(6) 2024, IT WAS DISCOVERED THAT AN IMPLANT WAS DEFECTIVE. THE CAPSULAR FIBROSIS WAS IN STAGE BAKER 2, THE BREAST WAS VISIBLY DEFORMED ON THE LEFT SIDE. THE IMPLANT WAS DEFECTIVE AND HAD ROTATED.

Additional Manufacturer Narrative

AS STATED IN THE LITERATURE, ¿A NUMBER OF RISK FACTORS FOR RUPTURE HAVE BEEN IDENTIFIED; THE MOST COMMON CAUSE IS SURGICAL INSTRUMENT DAMAGE.¿ (HANDEL, GARCÍA AND WINXTROM, 2013. BREAST IMPLANT RUPTURE: CAUSES, INCIDENCE, CLINICAL IMPACT, AND MANAGEMENT. PLAST. RECONSTR. SURG. 132: 1128.) ADITTIONALLY, RUPTURE IS A COMMON AND KNOWN REASON FOR COMPLAINTS, AND IT IS CLEARLY CHARACTERIZED IN THE PRODUCT DFU INCLUDED WITH THE IMPLANT, AS STATED ABOVE. ADDITIONALLY, NO CASES OF RUPTURE BECAUSE OF PRODUCT FAILURE HAVE BEEN REPORTED TO ESTABLISHMENT LABS EVER. THE MOST COMMON OVERALL INDICATION FOR REOPERATION IS CAPSULAR CONTRACTURE. (HANDEL, 2006). BREAST PROSTHESES ARE NO DIFFERENT FROM ANY FOREIGN MATERIAL IMPLANTED INTO THE HUMAN BODY IN THE SENSE OF TRIGGERING A PROTECTIVE IMMUNE REACTION FROM THE HOST. THIS ¿FOREIGN BODY RESPONSE¿ (FBR) IS UNIVERSAL AND IDEALLY REMOVES OR OTHERWISE SURROUNDS THE ¿IRRITANT MATERIAL¿ WITH FIBROUS TISSUE TO PREVENT UNWANTED IMMUNE SEQUELAE. A CAPSULE AROUND A BREAST IMPLANT IS, THEREFORE, A NECESSARY MECHANISM OF BODY DEFENSE, BUT IF EXCESSIVE IT CAN LEAD TO PAIN AND DEFORMITY OF THE BREAST (STEIERT, ET AL., 2013). IT HAS BEEN IDENTIFIED SEVERAL SIGNIFICANT RISK FACTORS FOR CAPSULAR CONTRACTURE, INCLUDING DEVICE FEATURES (SURFACE, SIZE), SURGICAL FACTORS (PERIAREOLAR INCISION, SUBGLANDULAR PLACEMENT, ANTIBIOTIC IRRIGATION), THE DEVELOPMENT OF HEMATOMA/SEROMA, AND THE USE OF A SURGICAL BRA. (CALOBRACE, 2018). PERIPROSTHETIC CAPSULES BECOME PATHOLOGICALLY ACTIVE AND UNDERGO A ¿CONSTRICTIVE FIBROSIS¿ DUE TO RETRACTION OF THE FIBROUS TISSUE, WHICH DEFORMS THEIR CONTENTS AND IMPAIRS THE AESTHETIC OUTCOME, MANIFESTED BY HARDENING OF VARIABLE DEGREE AND, IN ADVANCED CASES, BY DEFORMITY OF THE BREAST. (BAKER ET AL., 1990). 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: ¿CAPSULAR CONTRACTURE OCCURS WHEN THE CAPSULE TIGHTENS AND SQUEEZES THE IMPLANT. THIS CAN CAUSE THE IMPLANT TO TURN RIGID (FROM SLIGHTLY FIRM TO QUITE HARD) AND THE FIRMEST ONES CAN CAUSE VARYING DEGREES OF DISCOMFORT, PAIN, AND PALPABILITY. IN ADDITION TO THE FIRMNESS, CAPSULAR CONTRACTURE CAN RESULT IN A DEFORMED BREAST, VISIBLE SURFACE WRINKLING AND/OR DISPLACEMENT OF THE IMPLANT. DETECTION OF BREAST CANCER BY MAMMOGRAPHY MAY ALSO BE A MORE DIFFICULT. CAPSULAR CONTRACTURE MAY BE MORE COMMON FOLLOWING INFECTION, HEMATOMA, AND SEROMA, AND THE CHANCE OF IT HAPPENING MAY INCREASE OVER TIME. CAPSULAR CONTRACTURE IS A RISK FACTOR FOR IMPLANT RUPTURE, AND IT IS THE MOST COMMON REASON FOR REOPERATION IN AUGMENTATION AND RECONSTRUCTION PATIENTS. PATIENTS SHOULD ALSO BE ADVISED THAT ADDITIONAL SURGERY MIGHT BE NEEDED IN CASES WHERE PAIN AND/OR FIRMNESS ARE SEVERE (BAKER GRADES III OR IV) AND THAT CAPSULAR CONTRACTURE MAY HAPPEN AGAIN AFTER ADDITIONAL SURGERIES. CORRECTION OF CAPSULAR CONTRACTURE MAY REQUIRE SURGICAL REMOVAL OR RELEASE OF THE CAPSULE, OR REMOVAL AND POSSIBLE REPLACEMENT OF THE IMPLANT ITSELF¿. ¿BREAST IMPLANTS CAN POTENTIALLY REMAIN INTACT FOR DECADES IN THE BODY, BUT ALL SUCH DEVICES WILL FAIL AT SOME POINT. BREAST IMPLANTS RUPTURE WHEN THE SHELL DEVELOPS A TEAR OR HOLE. RUPTURE CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT IT IS MOST LIKELY TO OCCUR; THE LONGER THE IMPLANT IS IN PLACE. THE FOLLOWING MAY CAUSE IMPLANTS TO RUPTURE: DAMAGE BY SURGICAL INSTRUMENTS, IMPLANT STRESS, AND WEAKENING DURING IMPLANTATION, AGE AND DESIGN OF THE IMPLANT, SUBMUSCULAR RATHER THAN SUB-GLANDULAR LOCATION, THE OCCURRENCE OF POST-OPERATORY HEMATOMAS OR SEROMAS, FOLDING OR WRINKLING OF THE IMPLANT SHELL, EXCESSIVE FORCE TO THE CHEST, TRAUMA, COMPRESSION DURING MAMMOGRAPHIC IMAGING, AND SEVERE CAPSULAR CONTRACTURE¿. ESTABLISHMENT LABS REQUESTED THE UNIT TO CONFIRM THE EVENT AND TO PERFORM THE CORRESPONDING TESTING (INCLUDING BUT NOT LIMITED TO: REVISION AND CHARACTERIZATION UNDER THE MICROSCOPE OF THE RUPTURE SECTION, MECHANICAL TESTING ACCORDING TO APPROVED STANDARDS, ETC.). IT WAS INFORMED THAT THE PATIENT/DOCTOR HAS THE UNIT, AND IT IS PENDING TO CONFIRM IF IT CAN BE RETURNED. BREAST IMPLANTS ARE NOT CONSIDERED LIFETIME DEVICES, AND IMPLANT RUPTURE IS A RISK ASSOCIATED WITH BREAST SURGERY, WHICH CAN OCCUR AT ANY TIME. ALSO, A COMPLETE REVIEW OF THE DHR 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. SHELL MANUFACTURING: NO DEVIATION OR ABNORMALITY DETECTED. GEL MIXING: NO DEVIATION OR ABNORMALITY DETECTED. PRIMARY PACKAGING: NO DEVIATION OR ABNORMALITY DETECTED. STERILIZATION: NO DEVIATION OR ABNORMALITY DETECTED. SECOND STERILIZATION ROUND: NO DEVIATION OR ABNORMALITY DETECTED. SECONDARY PACKAGING: NO DEVIATION OR ABNORMALITY DETECTED. LABELING: NO DEVIATION OR ABNORMALITY DETECTED. AT ESTABLISHMENT LABS, WE ARE COMMITTED TO PATIENT SAFETY AND CONTINUALLY EVALUATE THE PERFORMANCE OF OUR DEVICES THROUGH POST-MARKET SURVEILLANCE OF REPORTED COMPLAINTS & ADVERSE EVENTS. CASE ALSO REPORTED WITH 3012883202-2024-00070.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: ¿ THE REPORTED DEVICE WAS RETURNED FOR EVALUATION. THERE WAS A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE. THE INITIAL VISUAL INSPECTION FOUND A DEVICE RUPTURE IN THE UNIT SN (B)(6). MICROSCOPE INSPECTION SHOWED TRACE MARKS IN THE SHELL CONSISTENT WITH THOSE OF A SHARP INSTRUMENT REPRODUCED IN OUR LABORATORY, THIS IS DISTINCT FROM THE PATTERN RESULTING FROM A SPONTANEOUS TEAR IN THE SHELL OF THE IMPLANT. ELONGATION TESTS CONFIRMED THE SHELL COMPLIED WITH THE INTERNATIONAL SPECIFICATION STANDARDS. ROTATION WAS NOT CONFIRMED DUE TO LACK OF CLINICAL EVIDENCE. CAPSULAR CONTRACTURE CAN BE CONFIRMED WITH THE CLINICAL EVIDENCE PROVIDED; HOWEVER REPORTED GRADE OF CAPSULAR CONTRACTURE IS NOT CONSIDERED A RISK FOR THE PATIENT. ADDITIONALLY, NO DEFECT/DAMAGE WAS FOUND IN THE UNIT SN (B)(6) UPON VISUAL INSPECTION. A COMPLETE REVIEW OF THE DHR FOR LOT 19055850 WAS CARRIED OUT, NO DEVIATION WAS FOUND IN THE MANUFACTURING PROCESS. REVIEW OF COMPLAINT HISTORY FOR THE REPORTED LOT NUMBER AND STERILIZATION RUN FOUND NO OTHER SIMILAR COMPLAINTS REPORTED IN THE PAST. ¿ 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: RUPTURE ¿ BREAST IMPLANTS RUPTURE WHEN THE SHELL DEVELOPS A TEAR OR HOLE. RUPTURE CAN OCCUR AT ANY TIME AFTER IMPLANTATION BUT IS MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IN PLACE. THE FOLLOWING MAY CAUSE IMPLANTS TO RUPTURE: DAMAGE BY SURGICAL INSTRUMENTS, IMPLANT STRESS AND WEAKENING DURING IMPLANTATION, IMPLANT AGE AND DESIGN, SUBMUSCULAR RATHER THAN SUBGLANDULAR LOCATION, THE OCCURRENCE OF POST-OPERATORY HEMATOMAS OR SEROMAS, FOLDING OR WRINKLING OF THE IMPLANT SHELL, EXCESSIVE FORCE TO THE CHEST, TRAUMA, COMPRESSION DURING MAMMOGRAPHIC IMAGING, AND SEVERE CAPSULAR CONTRACTURE. SILICONE GEL-FILLED IMPLANT RUPTURES ARE MOST OFTEN SILENT; THIS MEANS THAT MOST OF THE TIME, NEITHER THE DOCTOR NOR THE PATIENT CAN DETERMINE WITH THE PHYSICAL EXAMINATION IF THE IMPLANT HAS A TEAR OR HOLE IN THE SHELL. THE INTEGRITY OF BREAST IMPLANTS (AND DETECTION OF GEL FRACTURES AND/OR SILENT RUPTURES) CAN BE EVALUATED THROUGH SEVERAL TECHNIQUES. HIGH-RESOLUTION ULTRASOUND (HRUS) IS WIDELY ACCEPTED BY HEALTHCARE PROVIDERS AND PATIENTS FOR RUPTURE DIAGNOSIS. ADDITIONALLY, THE USFDA RECOMMENDS MAGNETIC RESONANCE IMAGING (MRI) SURVEILLANCE WITH THE FIRST MRI PERFORMED THREE YEARS POSTOPERATIVELY AND SUBSEQUENT MRIS PERFORMED EVERY TWO YEARS AFTER THAT. THESE RECOMMENDATIONS MAY VARY FROM COUNTRY TO COUNTRY, SO PLEASE PROVIDE THE PATIENT WITH ADDITIONAL GUIDANCE BASED ON YOUR COUNTRY'S CURRENT CARE STANDARDS. ESTABLISHMENT LABS DOES NOT RECOMMEND CLOSED CAPSULOTOMY FOR TREATING CAPSULAR CONTRACTURE BECAUSE IT CAN CAUSE IMPLANT RUPTURE. SOME SYMPTOMS MAY APPEAR, SUCH AS LUMPS SURROUNDING THE IMPLANT OR IN THE AXILLA, CHANGE OR LOSS OF SIZE OR SHAPE OF THE BREAST OR IMPLANT, PAIN, TINGLING, SWELLING, NUMBNESS, BURNING, OR HARDENING OF THE BREAST. THESE SYMPTOMS ARE NOT SPECIFIC TO RUPTURE AND MAY ALSO BE EXPERIENCED BY PATIENTS WHO HAVE CAPSULAR CONTRACTURE. SOME CASES HAVE BEEN REPORTED SUGGESTING THAT SILICONE-IMPLANT LEAKAGE SHOULD BE CONSIDERED IN THE DIFFERENTIAL DIAGNOSIS OF EOSINOPHILIA. "A CAPSULAR CONTRACTURE PERTAINS TO HYPERTROPHIC SCAR TISSUE INVESTING IN A FOREIGN BODY OR SURGICALLY IMPLANTED DEVICE, COMPROMISING THE AESTHETIC OUTCOME, RESULTING IN PAIN, BREAST DEFORMITY, AND OFTEN NECESSITATING FURTHER OPERATIONS4 . DETECTION OF BREAST CANCER BY MAMMOGRAPHY MAY ALSO BE CHALLENGING. CAPSULAR CONTRACTURE MAY BE MORE COMMON FOLLOWING INFECTION, HEMATOMA AND SEROMA, AND THE CHANCE OF IT HAPPENING MAY INCREASE OVER TIME. CAPSULAR CONTRACTURE OCCURS MORE COMMONLY IN PATIENTS UNDERGOING REVISION SURGERY THAN IN PATIENTS UNDERGOING PRIMARY IMPLANTATION SURGERY. CAPSULAR CONTRACTURE IS THE MOST COMMON COMPLICATION FOLLOWING IMPLANT- BASED BREAST SURGERY AND IS ONE OF THE MOST COMMON REASONS FOR REOPERATION". ROTATION ¿ ANTERIOR/POSTERIOR ROTATION, ALSO CALLED FLIPPING, HAS BEEN OBSERVED MORE FREQUENTLY WITH COHESIVE GEL IMPLANTS. THE FLAT BASE OF THE IMPLANT IS POSITIONED ANTERIORLY, DEFORMING THE BREAST OF THE PATIENT. PROPER PLACEMENT AND POCKET DISSECTION REDUCE THE RISK OF OCCURRENCE15. FLIPPING CAN BE TREATED WITH BIMANUAL MANIPULATION IN THE OFFICE AND CAN BE DONE REPEATEDLY IN RECURRENT CASES. HOWEVER, IN SOME CASES, REVISION SURGERY MAY BE NECESSARY TO REDUCE POCKET DIMENSIONS. LITERATURE HAS REPORTED THAT THE INTERACTION BETWEEN BREAST ENVELOPES, THE IMPLANT'S PHYSICAL CHARACTERISTICS, AND POCKET DISSECTION COULD CAUSE MALPOSITION. OTHER THEORIES INCLUDE THE INVOLUTION OF BREAST TISSUE. REGARDING IMPLANT CHARACTERISTICS, FLIPPING HAS BEEN ASSOCIATED WITH THE PRESENCE OR ABSENCE OF TEXTURING, IMPLANT SHAPE/PROFILE, AND THE GEL-FILLING RATIO (I.E., TO WHAT DEGREE THE IMPLANT HAS BEEN FILLED). OTHER FACTORS SUCH AS INFECTION, HEMATOMA/SEROMA, CAPSULAR CONTRACTURE, DISSECTION, SURGEON¿S EXPERIENCE, PHYSICAL ACTIVITY, AND EXTERNAL MANIPULATION OF THE IMPLANT COULD POTENTIALLY CONTRIBUTE TO THE DEVELOPMENT OF THIS COMPLICATION. ¿ IN CONCLUSION, IT WAS DETERMINED THAT A PROBABLE CAUSE FOR THE EVENT REPORTED WAS A CUT RESULTING FROM A SHARP INSTRUMENT USED WHICH COULD HAVE WEAKENED THE SHELL. ¿ ESTABLISHMENT LABS WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS/TRENDS.