MAUDE Adverse Event Report: ALLERGAN NATRELLE STYLE 68HP SMOOTH SALINE BREAST IMPLANTS; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number 68HP

Device Problems Gel Leak (1267); Material Rupture (1546); Malposition of Device (2616)

Patient Problems Arthritis (1723); Asthma (1726); Autoimmune Disorder (1732); Dehydration (1807); Emotional Changes (1831); Fatigue (1849); Fever (1858); Hair Loss (1877); Headache (1880); Inflammation (1932); Menstrual Irregularities (1959); Muscle Spasm(s) (1966); Nausea (1970); Neuropathy (1983); Pain (1994); Thyroid Problems (2102); Urinary Tract Infection (2120); Blurred Vision (2137); Weakness (2145); Brain Injury (2219); Anxiety (2328); Toxicity (2333); Arthralgia (2355); Depression (2361); Numbness (2415); Sleep Dysfunction (2517); Cognitive Changes (2551)

Event Date 01/22/2008

Event Type  Injury  

Event Description

Immediate problem, doctor didn't listen, allergan said implants don't get you sick, became chronically ill/disabled over following decade, both ruined, rupture, capsular contracture, right one slipped into skull, tumors grew into body, spine, cerebrum, neck, shoulders, all over, silicone poisoning from shell, severe cognitive dysfunction led to temporary psychosis last year leading to 6 day hospitalization, nearly killed me, my body is draining all torturous tumors, ended up using wheelchair, cane, walker, unable to work and use college degree, had to put my ministry on a sabbatical, life destroyed, allergan kept telling me implants don't make you sick.This is not true.The smooth are just as dangerous as the textured.So many lives destroyed.The silicone in the shell leaks out causing poisoning.The biofilm reacts to the implant regardless if smooth or textured.Please do something and save lives.Thank you.Oh, the draining feels like brillo and chards of glass being pushed through the veins including eyes.Sincerely, (b)(6).With god all things are possible - matthew 19:26.Stand for truth.God commands us to be courageous.Start reporting to med-watch and local medical board if sick from any medical device, please.Help save lives.Except for levoscoliosis, ptsd, and kidney stones, all noted health issues developed after implant surgery reflex sympathetic dystrophy aka complex regional pain syndrome, neuropathy, spinal arthritis, osteoporosis, fibromyalgia, chronic fatigue syndrome, ptsd, awaiting tests for cancer and traumatic brain injury; covid, backup chronic systemic joint pain, blurry vision, levoscoliosis, migraines, asthma; hair loss, nails stopped growing, cognitive dysfunction, nausea, muscle spasms/pain/weakness, hearing loss; choking sensations, chronic uti and yeast, bowel dysfunction, equilibrium off, degenerate disc disease, spinal stenosis; anxiety/depression/insomnia/mood swings, high cholesterol, chronic fever 2017 before covid, hypothyroidism, neuro with possible accommodative instability, kidney stones, chronic autoimmune dysfunction, chronic inflammation, chronic light sensitivity, flash rashes; teeth/jaw pain, countless tumors, chronic heavy metal poisoning/silicone leaks from shell, capsular contracture, rupture right implant, displaced/malpositioned laterally, then into skull both implants ruined; teeth grinding, mouth sores, saline gets trapped in tumors, burning/stinging, bio-film expands throughout body, pellets tumors explode, hard pellets, and jello like substances fall out, roll, snap, crack, pop feel like dying feels like fiberglass missed menstrual cycles yellow color exits pores hot/cold chronic dehydration body numbness/pins/needles feels like scabies crown of thorns/body temporary paralysis the more my body rejects and drains, the better i feel my findings: breast implants cause neurotoxicity of the amygdala, hippocampus, lining of small/large intestines polluting bloodstream interfering with brain transmission affecting frontal lobe/encephalitis/traumatic brain injury/cognitive dysfunction recommend fda prohibits medical device manufacturers from selfregulation and demand independent 3rd party/regulations."numerous; please contact for list as site keeps ending session, writing too long/losing info." fda safety report id# (b)(4).

• Brand Name: NATRELLE STYLE 68HP SMOOTH SALINE BREAST IMPLANTS
• Type of Device: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 10343604
• MDR Text Key: 201195357
• Report Number: MW5095785
• Device Sequence Number: 2
• Product Code: FWM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/26/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 68HP
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 51 YR
• Patient Weight: 54