Below is a part of failure analysis report. The analysis was conducted by Doctors J.J.B. Pierre Blais, B.Sc., Ph.D., C.Chem., F.C.I.C. at Innoval, failure analysis report for the 35 year old female implants and capsular.
Another part of the report can also be found here
Symptoms: fatigue, night sweating, sustained chronic infectlon, involuntary muscle' tremors, breathing difficulties, stabbing/burning chest pain, skin sores with shedding of calcific particles, brown discolouration on calfs, hair loss, tingling (arms and feet), hypersensitivity to mold, chemicals,' dust, chronic fatigue, skin discolouration on legs (red streaks), vision disturbances, sound of 'clicking' in ribcage and perception of movement in sternal area, recurrent asthma, weight loss, skin rash, blue discolouration on back, swelling of lower lip, lower digestive trace problems, recurrent mouth ulcers, loss of sensation in extremities, low grade fever, neurocognitive symptoms, perception of rising intracranial pressure, nausea, capsular contracture, more severe on left, numbness in left arm. exfoliation of hard particles from skin sores.
History: (info from patient) (dates shown as month/day/year)
06/xx/02 - augmentation mammoplasty with submuscular insertion of silicone gel-filled breast implants of 265 gm (Poly Implant Protheses (PIP) round, textured, Low Profile, Early Issue, rated at 285 cc, as confirmed by patch markings and shell measurements not 265cc)
06/xx/02 - immediate complications - extreme pain, lasting for 3 days, medium in intensity after i week
xx/xx/02 - lower half of implant visualized as a distinct object through skin - (probable partial extrusion of implant from under pectoralis muscle)
07/xx/06 - onset of illness after alcohol consumption, followed by two weeks of fatigue and massive night sweating (probable onset of multiple food sensitivities)
xx/xx/OB - peptic ulcer
xx/xx/O9 - childbirth after in vitro fertilization, difficult pregnancy with swelling, weight gain, breathing problems and chest pain
12/xx/09 - left breast infection (mastitis) from breastfeeding - antibiotics
xx/xx/xx - involuntary muscle movement (tremors) - MRI of brain - findings unremarkable
11/xx/10 - diagnosis of Essential Tremor, symptoms worse on left; treatment with Propranolol precluded because of low blood pressure
Nov/Dec 2010 - diagnosed with ADHD, breathing problems, stabbing chest pain, skin sores and brown discoloration on calfs, hair loss, tingling in arms
02/xx/11 - hypersensitivity to mold metabolites, extreme fatigue, tingling in feet
03/xx/11 - chest x-ray for continuing breathing difficulties, dry cough, hypersensitivity to many environmental impurities - unremarkable findings, however, diagnosis of stress and sleep deprivation made
03/xx/11 - extreme breathing difficulties, dipgoloration of skin on legs (red streaks), hives, vision disturbances - diagnosis of hyperventilation and panic attack
04/xx/11 - sound of 'clicking' in ribcage, unnatural movement in sternum, recurrent asthma and hypersensitivity to chemicals and dust, stabbing pain in lower back with momentary paralysis of legs, weight loss despite increased food intake, chronic pain in lower back, lumpiness in tissue; sudden cessation of burning chest pain; diagnosis of broken rib with recommendation to take vitamin D
04/xx/11 - lower digestive tract problems, weight loss, increased tingling in arms and legs, skin became red under breast when stretching and clicking sounds on movement, lump in right breast
05/xx/11 - swelling and darkening skin color, upper abdomen; exudation of black material from abdomen and upper stomach
06/xx/11 - skin rash, rapid onset of red and brown skin discoloration
07/xx/11 - blue discoloration on back, swelling of lower lip - treated with antibiotics; onset of gingivitis and recurrent mouth ulcers
08/xx/11 - while on holiday, developed throat infection, mouth ulcers, hair loss, brown rash on back, sudden swelling of upper abdomen, extreme fatigue - diagnosed as dislocated abdominal muscle; examination in Iceland provided a contradictory diagnosis of hyperventilation and stress
08/xx/11 - breathing difficulties (lack of air) - CT scan of chest - breast prostheses noted; degeneration of spinal structures, more so on right; no evidence of fractures; 8 mm calcified kidney cyst; lungs normal (review of low resolution copies of radiographic projections at Innoval reveals direct contact of at least one implant with bony tissue and frank shell failure of the implant; clearly visualized spherical contracture).
09/xx/11 - perception of intracranial pressure
10/xx/11 - recurrent rashes, swelling and itching, eye problems including dry eyes, vision disturbances, ear rash and pain
11/xx/11 - loss of sensation in feet, neurocognitive symptoms, intracranial pressure, nausea
11/xx/11 - serology - variable blood creatine level, peaking at time of worsening symptomatology
(possible renal clearance anomaly)
12/xx/11 - heavy eye discharge in morning, face numbness, sustained low grade fever; temporary relief of some symptoms during antibiotic treatment with increased intensity of symptoms upon cessation of antibiotics; capsular contracture, more severe on left; skin discoloration, numbness in left arm; sudden hives with chest and neck reddening, increased neurocognitive symptoms
01/03/12 - removal of implants
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