FDA Adverse Event Summary report: N

BREAST IMPLANT EXPANDER/SMOOTH ROUND SPECTRUM SALINE

MDR report key: 2873439 · Received December 11, 2012

Report

Report Number
MW5028063
Date Received
December 11, 2012
Date of Event
January 9, 2012
Report Date
November 19, 2012
Manufacturer
MENTOR CORP
Product Code
FWM
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAD LEFT NIPPLE SPARING MASTECTOMY, SENTINEL LYMPH NODE BIOPSY AND LEFT IMMEDIATE BREAST RECONSTRUCTION DONE ON (B)(6) 2012. SURGERY WAS UNEVENTFUL, I HAD HUGE SWELLING UPPER LEFT BREAST AREA POST SURGERY. I WAS DISCHARGED THE NEXT DAY WITH 2 BREAST DRAINS AND INSTRUCTED TO FOLLOW-UP WITH SURGEON. I FOLLOWED UP WITH MY PLASTIC SURGEON AT LEAST TWICE A WEEK. BREAST SURGERY WAS VERY PAINFUL. ON THIRD WEEK POST-SURGERY, I HAD SEVERAL MEDICAL COMPLAINTS: HEADACHE, SHORTNESS OF BREATH, NUMBNESS OF FACE, AND EVENTUALLY MOTTLING, REDNESS AND SWELLING OF LEFT BREAST, SWELLING ON PORT BELOW INTRA-MAMMARY FOLD. I HAD SEVERAL VISITS TO URGENT CARE, EMERGENCY HOSPITAL, AND DOCTORS' OFFICES. I DEVELOPED FEVER AND CELLULITIS ON BREAST; WHICH FELT LIKE A BALLOON. I WENT TO URGENT CARE ON (B)(6) 2012; WAS GIVEN VANCOMYCIN IV. THE NEXT DAY, I FELT THAT THE LEFT BREAST DEFLATED AND AREA AROUND PORT (INTRA-MAMMARY FOLD) FILLED WITH MORE FLUID. I SAW MY SURGEON WHO ORDERED ADMISSION TO HOSPITAL FOR SURGICAL EXPLANTATION, IRRIGATION, AND DEBRIDEMENT. SURGERY WAS PERFORMED ON THE NEXT DAY, (B)(6) 2012. CLOUDY SEROMA AND GRANULATION TISSUE WAS EVACUATED AND SALINE BREAST EXPANDER AND PORT WAS REMOVED. SAMPLES OF FLUID AND TISSUE WERE SUBMITTED FOR CULTURE AND SENSITIVITY TESTING, BUT NO HISTOPATHOLOGICAL SAMPLES WERE TAKEN. SHE SAID THAT THE IMPLANT WILL BE SUBMITTED FOR EXAMINATION AND THEN RETURNED TO MFR. I WAS GIVEN CONTINUOUS VANCOMYCIN TREATMENT FOR 2 DAYS AND WAS PRESCRIBED CIPRO AND ORAL PAIN MEDS. I HAD FOLLOW-UP VISITS AT HER OFFICE AND 2 DRAIN TUBES WERE REMOVED AFTER SEVERAL DAYS. THE INITIAL CULTURE TEST RESULTS AT (B)(6) CAME OUT AS ACID-FAST BACILLI, A FAST GROWER. I SAW AN INFECTIOUS DISEASE DOCTOR FOR EMPIRICAL TREATMENT WHILE WAITING FOR SENSITIVITY TESTING RESULTS. I STARTED WITH A COMBINATION TREATMENT OF CLARITHROMYCIN AND DOXYCYCLINE. THE TREATMENT WAS CONCURRED BY MY CURRENT INFECTIOUS DISEASE DOCTOR AT (B)(6) HOSPITAL. THE SAMPLE WAS SENT TO (B)(6) FOR FURTHER IDENTIFICATION AND SENSITIVITY TESTING. RESULTS OF THE TEST IDENTIFIED AS M. FORTUITUM, SENSITIVE TO CLARITHROMYCIN, BUT RESISTANT TO DOXYCYCLINE. MY INFECTIOUS DISEASE DOCTOR, REPLACED THE DOXYCYCLINE TO CIPRO IN COMBINATION WITH CLARITHROMYCIN. I FINALLY CONSULTED WITH (B)(6); WELL KNOWN EXPERTS IN DIAGNOSIS AND TREATMENT OF MYCOBACTERIAL INFECTIONS. I WANTED TO GET A "DEFINITE REGARDING CAUSE" OF PERSISTENT FIBRINOUS NODULAR TISSUE ON MY LEFT BREAST AND AXILLA. I FINALLY SAW AN INFECTIOUS DISEASE DOCTOR, WHO THEN PRESENTED MY CASE FOR REVIEW AT THEIR DEPARTMENT STAFF MEETING. ASSESSMENT WAS POSSIBLE MYCOBACTERIUM FORTUITUM IATROGENIC HEALTH CARE ASSOCIATED INFECTION OF THE LEFT BREAST IMPLANT. BECAUSE OF ABSENCE OF PERI-OPERATIVE PATHOLOGY TO LOOK FOR GRANULOMAS, NOR ABILITY TO RE-CULTURE THE SITE, PLAN WAS TO GET MRI OF RESIDUAL BREAST TISSUE AND CONSULT WITH SURGEON WHO SPECIALIZED IN MYCOBACTERIAL INFECTIONS. MRI RESULTS: SOME ABNORMAL FINDINGS, BUT COULD NOT RULE OUT IF THIS IS DUE TO INFECTIOUS DISEASE OR POST-SURGICAL CHANGES. I SAW A SURGEON AT (B)(6). SHE CONCURRED WITH (B)(6) TREATMENT OF 6 MONTHS ANTIBIOTICS AND RETURN APPOINTMENT FOR REASSESSMENT IN 3 MONTHS. ANTIBIOTIC COMBINATION WERE PRESCRIBED, CHANGED FROM TIME TO TIME TO PREVENT BACTERIAL RESISTANCE AND SIDE EFFECTS. ON THE LAST FEW WEEKS OF TREATMENT, I WAS SWITCHED TO TAKING SULFISOXAZOLE/TRIMETHOPRIM ALONE BECAUSE I WAS NOT ABLE TO TOLERATE THE SIDE EFFECTS FROM AVELOX, CIPRO, ETC. ON (B)(6) 2012, I HAD A RETURN DOCTOR'S APPOINTMENT AND MRI AND BLOOD TEST AT (B)(6). SURGEON'S ASSESSMENT WAS THAT I HAVE NO APPARENT LESION OF MYCOBACTERIAL DISEASE. MY INFECTIOUS DISEASE DOCTOR WITHDREW ANTIBIOTIC TREATMENT ON (B)(6). I STARTED HAVING STOMACH PAINS RIGHT AFTER I WITHDREW MY ANTIBIOTIC TREATMENT. THE PAIN CONTINUED AND SPREAD ON THE ABDOMEN SPECIALLY ON THE LEFT LOWER QUADRANT. MY OBGYN DOCTOR PERFORMED ENDOMETRIAL BIOPSY WHICH RESULT WAS NEGATIVE. MY GASTROENTEROLOGIST ALSO PERFORMED COLONOSCOPY LAST WEEK AND AWAITING FOR RESULTS OF THE BIOPSY. HE SUGGESTED BREATH TEST TO RULE OUT SIBO. I WOULD LIKE TO SEE IF I GET AN IMPROVEMENT FROM THE COLON CLEANSING BEFORE I SCHEDULE TESTING. I AM CURRENTLY TAKING PROBIOTICS AND PANTOPRAZOLE 40 MG DAILY AND I HAVE SEEN IMPROVEMENT SINCE COLONOSCOPY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BREAST IMPLANT EXPANDER/SMOOTH ROUND SPECTRUM SALINE SALINE BREAST IMPLANT (EXPANDER) FWM MENTOR CORP REF 350-1480 6503382

Patients

Seq Age Sex Outcome Treatment
1 59 YR Hospitalization| L| R| S