Description of Event or Problem · 0
TO: FDA, CENTER FOR DEVICES AND RADIOLOGICAL HEALTH ALLERGAN AESTHETICS, AN ABBVIE COMPANY SUBJECT: URGENT ATTENTION: BREAST IMPLANT ILLNESS AND SUSPECTED BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIAALCL) TO WHOM IT MAY CONCERN, MY NAME IS (B)(6), AND I AM WRITING TO YOU NOT JUST AS A PATIENT, BUT AS A WOMAN WHO HAS ENDURED YEARS OF SUFFERING, FEAR, AND UNANSWERED QUESTIONS; ALL CONNECTED TO BREAST IMPLANTS THAT I ENTRUSTED FOR MY HEALTH, CONFIDENCE, AND HEALING. WHAT WAS MEANT TO BE A STEP TOWARD RECLAIMING MY LIFE HAS INSTEAD STOLEN YEARS OF IT. FOR THE PAST THREE TO FOUR YEARS, I HAVE BATTLED A WORSENING CONSTELLATION OF SYMPTOMS, AND DESPITE RELENTLESS EFFORTS TO SEEK HELP, I HAVE BEEN LEFT TO FIGHT THIS UPHILL BATTLE ALONE. MY SYMPTOMS INCLUDE: PERSISTENT FLUID BUILDUP IN AND AROUND MY BREASTS BURNING, STINGING, AND LEAKING SENSATIONS FROM MY BREAST AREA AND CHEST SKIN RASHES AND PAINFUL INFLAMMATION SPREADING THROUGH MY CHEST, NECK, AND ARMS CHRONIC SWELLING, DISCOMFORT, AND SHARP PRESSURE PAIN ASYMMETRY AND IMPLANT DISPLACEMENT CAUSING BOTH PHYSICAL AND EMOTIONAL DISTRESS EPISODES WHERE FLUID SEEMS TO RELEASE OR "BURST" THROUGH MY SKIN SEVERE ANXIETY, WEIGHT LOSS, AND DEBILITATING FATIGUE SIGNIFICANT MENTAL AND EMOTIONAL ANGUISH DESPITE UNDERGOING COUNTLESS APPOINTMENTS, TESTS, AND REFERRALS, NO ONE SEEMS ABLE TO PINPOINT A CAUSE, UNTIL I LEARNED ABOUT BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL). SUDDENLY, EVERYTHING MADE SENSE. THE SYMPTOMS, THE FLUID, THE SKIN REACTIONS, ALL OF IT MATCHING CASES THAT HAVE SINCE BEEN CONFIRMED IN OTHER WOMEN LIKE ME. BUT HERE IS THE TERRIFYING PART: THERE IS NO SIMPLE BLOOD TEST. THERE IS NO RELIABLE SCREENING. UNLESS THERE IS ENOUGH FLUID TO SAMPLE, I AM LEFT TO SUFFER WHILE HOPING SOMEONE EVENTUALLY TAKES THIS SERIOUSLY ENOUGH TO INTERVENE. MEANWHILE, THE SCAR TISSUE, THE IMPLANTS, AND THE POTENTIAL FOR UNDETECTED LYMPHOMA REMAIN IN MY BODY, DAY AFTER DAY, THREATENING MY HEALTH, MY SAFETY, AND MY PEACE OF MIND. THE HARDEST PART OF ALL OF THIS IS INSURANCE. I AM TRAPPED IN A SYSTEM THAT MAKES IT NEARLY IMPOSSIBLE TO GET THE NECESSARY IMAGING, REFERRALS, AND REMOVAL OF THESE IMPLANTS. EVEN WHEN THERE IS SUSPICION OF BIA-ALCL, I AM MADE TO FIGHT, APPEAL, AND PROVE MYSELF REPEATEDLY, WHILE MY BODY DETERIORATES. THIS LETTER IS NOT JUST ABOUT ME, IT'S ABOUT EVERY WOMAN WHO IS EXPERIENCING THIS AND WHO HAS FELT SILENCED, IGNORED, OR DISMISSED. THE LACK OF ACCESSIBLE DIAGNOSTICS, THE LACK OF EDUCATION TO FRONTLINE PROVIDERS, AND THE FINANCIAL BARRIERS TO REMOVING OR REPLACING THESE IMPLANTS ARE UNACCEPTABLE. NO WOMAN SHOULD HAVE TO PLEAD TO GET A POTENTIAL TICKING TIME BOMB REMOVED FROM HER BODY. I AM CALLING UPON ALLERGAN AND THE FDA TO ACKNOWLEDGE THE FULL WEIGHT OF THIS ISSUE, NOT JUST AS A RARE COMPLICATION BUT AS AN ACTIVE, LIFE-THREATENING STRUGGLE FOR REAL WOMEN LIKE ME. MY LIFE IS WORTH MORE THAN A CHECKLIST OF SYMPTOMS THAT ONLY QUALIFY IF I CHECK THE RIGHT BOX. PLEASE HEAR ME. PLEASE HELP ME. MY HEALTH, MY LIFE, AND THE LIVES OF COUNTLESS OTHERS ARE DEPENDING ON IT. SINCERELY, (B)(6) DOB (B)(6) 1977. I, (B)(6), AM FORMALLY SUBMITTING THIS DETAILED ACCOUNT OF MY PERSONAL MEDICAL EXPERIENCE, SUFFERING, AND ONGOING UNRESOLVED MEDICAL CRISIS, ALL OF WHICH I FIRMLY BELIEVE STEM DIRECTLY FROM COMPLICATIONS RELATED TO ALLERGAN BREAST IMPLANTS, SPECIFICALLY THOSE INVOLVED IN MY BREAST CANCER RECONSTRUCTION JOURNEY. IN 2010, I UNDERWENT A DOUBLE BILATERAL MASTECTOMY DUE TO BREAST CANCER. THIS PAINFUL DECISION WAS FOLLOWED BY BREAST RECONSTRUCTION USING ALLERGAN IMPLANTS, WHICH INCLUDED THE USE OF EXPANDERS, ALLOMAX MESH, AND LATER, ALLODERM MESH. DURING THE INITIAL RECONSTRUCTION, MY RIGHT IMPLANT BECAME INFECTED, FORCING ME TO ENDURE THE TRAUMA OF IMPLANT REMOVAL, PLACEMENT OF A PICC LINE FOR IV ANTIBIOTICS, AND THE PHYSICAL AND EMOTIONAL STRAIN OF PREPARING FOR A SECOND RECONSTRUCTION. SEVERAL MONTHS LATER, I WAS RE-SUBJECTED TO EXPANDERS, MESH, AND ANOTHER ALLERGAN IMPLANT. SINCE THAT TIME, MY LIFE HAS SPIRALED INTO A PATTERN OF SEVERE, PROGRESSIVE, AND DEBILITATING SYMPTOMS WHICH I NOW UNDERSTAND ARE CONSISTENT WITH BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL) AND, POSSIBLY, ITS MORE DIFFUSE VARIANTS. THESE SYMPTOMS INCLUDE BUT ARE NOT LIMITED TO: DOCUMENTED SYMPTOMS: SEVERE, PERSISTENT BREAST SWELLING AND ASYMMETRY IMPLANT MALPOSITION (ONE IMPLANT HAS DROPPED, ONE ELEVATED) SPONTANEOUS FLUID LEAKAGE AND DRAINAGE BREAST PAIN (BURNING, STINGING, SHOOTING) TIGHTNESS AND SEVERE SKIN SENSITIVITY CHRONIC BREAST AND CHEST AREA RASHES SKIN BURNING SENSATION AND NOTICEABLE REDNESS NEUROLOGICAL SYMPTOMS INCLUDING TINGLING, NERVE PAIN, AND RADIATION OF PAIN INTO NECK AND ARMS FATIGUE THAT IS RELENTLESS AND WORSENS OVER TIME SEVERE, RANDOM FLUID ACCUMULATION AND LEAKAGE WHICH I HAVE FELT BURST THROUGH MY SKIN WITHOUT INJURY INEXPLICABLE SKIN REACTIONS, BURNING, DISCOLORATION, PEELING, AND LESIONS UNCONTROLLABLE ANXIETY, PANIC, AND DISTRESS LIKELY TRIGGERED BY UNDERLYING. REFERENCE REPORT # MW5168521, # MW5168522, # MW5168523, # MW5168524, # MW5168526.