5 post implants. I used to be an active, social, happy, hard-working person. Cultures were done, idc was called in and i had pseudomonas aeruginosa and serratia marcescens. Plastic surgeon does not know if or when surgical correction can take place. I requested an mri and it was shown both implants were ruptured. I had these mentor silicone implants placed in 2007. She experienced breast asymmetry (the right breast was lower than the left breast) on (b)(6) 2011, so the patient underwent a revision procedure on (b)(6) 2017 in (b)(6). Link. I can walk short distances with the use of a cane; i still have to use an electric scooter or be pushed in a wheelchair if i have to stand for long or go very far. Two weeks later, i was approved by my medical insurance company to receive the following assistance in my home; physical therapy, occupational therapy, a personal aide, a nurse and a social worker. It was reported that a patient (unknown age and gender) with mentor breast prostheses (unknown lot # or catalog #) was diagnosed with alcl (diagnosis date unknown). I have mentor breast implants for reconstruction from cancer 2015. Have various test. It was reported that a (b)(6) year-old female underwent primary augmentation surgery using mentor silicone implants. Also, gel fracture is a new phenomenon that has been identified for . I couldnt think clearly, and i could not sleep. Painful joints (most hands, knees, hips, shoulders) bone pain swelling of hands, tight skin. I was a 34 B previously. The nipples were 99% erect and felt swollen for most of the time. FDA Documents: Approval Date: November 17th, 2006 Recalls Large Study:The follow-up rate was 20.1% at 7 yearsand the final report is on year 9 in 2015. Case-control studies were later terminated after the release of Tuftss evidence report. As of today, (b)(6) 2017, im taking cipro 500 mg twice daily, drain is still intact, takes me over 2 hours to bathe, dry my hair and dress, because im fatigued. This implants are taking my life away . 350-3420 It was reported that a (b)(6) female patient underwent bilateral breast prostheses implantation with mentor gel implants on (b)(6) 2013. The patient reported to have several undisclosed illnesses within months of getting the implants put in. I suffered from extreme fatigue, and my joints were swollen, especially my right knee. I had them taken out. There i saw my right implant was completely ruptured. Hair thinning and lost. 200 cc both sides b cup to c cup. I had silicone breast implants from mentor in 2013. I had the implants removed at the end of 2015. Link. Cause 2. Was rushed to surgery, large hematoma was removed and hospitalised for several days. I had the breast implants removed on (b)(6) 2015 and began the process of detoxing the chemicals and heavy metals that are in silicone gel breast implants. For example, these implants require a larger surgical incision than saline or less cohesive silicone gel-filled breast implants. Link. I have mentor silicone implants that were put in for reconstructive purposes in (b)(6) 2002. Since then i had a lot of health issues, most of them have been of autoimmune reactions involving: vascular system, neurological (brain fog, numbness in limbs), asthma, heart palpitations, extreme fatigue, hormonal issues, sensitivity to chemicals, allergies. Bilateral breast pain from breast implants. Sudden decline in health and increase in pain of area of implants as well as systemically. Extreme hair loss that has created balding (alopecia) on my scalp. She also had memory problems, fogginess, tinnitus on the left side, headache, joint pain, cold. The patient also reported breast pain which appeared in 2016 along with lump in her breast. my first ones were removed via the area incision and now i have an incision in the inframammary location. Since I had them implanted my body has changed tremendously from brain fog, GI issues with severe bloating. (Unknown if it is Mentor saline or silicone). The shell is filled with MemoryGel, Mentor's proprietary formulation of silicone. No patient consequences were reported. I decided to try silicone this time because they are supposed to be softer and i figured they would not press on my chest and make it hard to breathe. Immediately, my breathing was cured! Now i have white-ish pus discharge (fungal infection), extreme pain/burning in both breasts as well as numbness/tingling/burning sensation in arms/shoulder, grade #4 capsular, contracture, trouble breathing properly, memory loss/brain fog, blurry vision, swollen throat lymph nodes, loss of motion in both arms, major teeth issues due to implants, leaky gut/ibs, extreme anxiety and depression, bed ridden, muscle pain, unknown opage spots on breast ultrasound, candida issues/fungal issues/bacterial issues, muscle loss, extremely achy joints, massive fatigue, sinus issues, migraines. I am getting sicker and sicker. The fda say they are safe. DoNotPay can assist you with a simple, easy-to-use process in one place. Since that date my health has steadily declined with a fast decline noted after 2. Read Mentor's full statement below: "Nothing is more important to Mentor than the health and safety of the . On (b)(6) 2015 i had woke up to a horrible pain, ended up capsular contracture grade 4 (baker), then ended up ruptured right breast tissue and implant as well as the following: fatigue or chronic fatigue, cognitive dysfunction (brain fog, difficulty concentrating, word retrieval, memory loss), muscle aches, pain, and weakness, joint pain and soreness, hair loss, dry skin, eyes, mouth, hair, weight gain or weight loss, easy bruising and slow healing of wounds, temperature intolerance, low libido, ringing in the ears, heart palpitations, photosensitivity, shortness of breath, metallic taste in the mouth, oral thrush (white tongue), night sweats, skin rashes, insomnia, estrogen/progesterone imbalance or diminishing hormones, swollen and tender lymph nodes in the breast area, underarms, throat, neck, or groin, tingling or numbness in the arms and legs, burning pain around the chest wall or breasts, cold and discolored hands and feet, foul body odor, muscle twitching, dehydration, frequent urination, chronic neck and back pain, nail changes (cracking, splitting, slow growth, etc), skin freckling, pigmentation changes (darkening or white spots), or an increase in papules (flesh colored raised bumps), edema (swelling) around eyes, premature aging, decline in vision or vision disturbances, liver and kidney dysfunction, digestive and gastrointestinal issues, food intolerances and allergies, smell or chemical sensitivities, new or persistent infections viral, bacterial, and fungal (candida), reoccurring sinus infections, throat clearing, cough, difficult swallowing, choking feeling, chronic inflammation, feeling like you are dying, headaches, dizziness and migraines, mood swings, emotional instability, anxiety, panic attacks, suicidal thoughts, depression, hypo/hyper thyroid symptoms, hypo/hyper adrenal symptoms, symptoms or diagnosis of fibromyalgia, symptoms or diagnosis of lyme, common autoimmune disease, 33 different metals and chemicals including silicone. * In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. I believe as i stated before they have exacerbated my autoimmune challenges. Re-Op Study: This studywill collect data when a participant from the original Large Post-Approval Study with MemoryGel breast implants requires a secondary procedure/reoperation. This is not a one time event, but this was the beginning of many different health issues i had. 350-3230 Frequent migraines with vomiting extreme fatigue hair loss blurred vision acting joints right arm-numbness and pain 20 pound weight gain and bloating of abd and frequent heartburn, brain fog with memory loss and difficulty focusing anxiety and flat affect cold intolerance esp hands and feet. Had mammogram at (b)(6) hospital and became very ill within 3 weeks. Core Study:The follow-up rate was 62% at 10 years. Epidurals and physical therapy for years. The plastic surgeon performed what is called a dual-plane approach half under/half over the muscle to give a tear drop shape). I went to the er, where they werent sure what was wrong and gave me antibiotics, which had no effect. 325 0 obj <>/Filter/FlateDecode/ID[<4FD22ED3B7DCE845A6E6AEF3AE0F309B>]/Index[304 37]/Info 303 0 R/Length 103/Prev 225431/Root 305 0 R/Size 341/Type/XRef/W[1 3 1]>>stream It was reported that a (b)(6) female patient underwent breast augmentation revision with mentor gel device on (b)(6) 2011. Gi issues, pain. Manufacturer site is unknown. in this way, she confirmed that it could be breast implant illness that i was suffering from. (Unknown if it is Mentor saline or silicone). Dermatologist and allergist were seen without relief. The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates. Rx meds: i guess i will list all that are prescribed many i have not able to take because sadly i cannot afford them anymore. Released from hospital after 5 days. I have been diagnosed with sjogrens, myalgia, low c4 and anemia. However, no further information has been made available. Could barely walk. Difficulty sleeping, difficulty recalling words (mixing up words), short term memory issues. PMAs with Product Code = FTR and Original Applicant = MENTOR CORP. I fortunately found a (b)(6) support group for women with breast implant illness, what i believed to have. All symptoms started on the right side of my body, and were more severe than on the left side of my body. Link. I had to have a double mastectomy in 2009 with immediate breast implants. Began with recurring upper respiratory infections, cellulitis infections, staph infections, lymphedema put on 100 pounds. These devices are not safe. Cant wear socks or shoes only flip flops. Patient was bedridden. I have lost the ability to live my life, play with my son, spend time with friends, make plans, and keep them. Burning red rash on my eyelids. I was healthy and active prior to breast implants. The recommendations in this guidance supplement the recommendations in the FDA's Saline, Silicone Gel, and Alternative Breast Implants guidance, issued September 29, 2020 superseding the prior version dated November 17, 2006. Mri confirmed that bilateral implants were ruptured. They also recommended ultrasound at the discretion of the radiologist. I want them removed as soon as possible because i know they are toxic and my body is reacting to them. There may also be a variety of associated costs. I felt like i was dying. I have 35 symptoms of Breast Implant Illness. The patient must be given the opportunity to initial and sign the patient decision checklist and it must be signed by the physician implanting the device. Patient suffered pain on the left side for the past year and it was getting worse. In 2019 I started experiencing severe lower abdominal pain that sent me to the emergency room several times. Around 2005, i started having raynauds disease which always affects my nipple and toes when cold. Link. I believed the fda and the plastic surgeon. 3 350-3380 Used in breast reconstruction surgery, MENTOR CPX TM 4 Breast Tissue Expander is designed to expand primarily in the lower portion of the breast, so the resulting pocket will accommodate the implant and slope like a natural looking breast. (Unknown if it is Mentor saline or silicone). It was reported by the therapeutic goods association (australian authority) that this includes a confirmed pathology report. I was later diagnosed with postural orthostatic tachycardia syndrome and placed on metoprolol. Had breast implants put in and have had failing health since. As time continues to pass, more symptoms seem to be showing up. Had breast augmentation in (b)(6) 2013. Mri confirmed that the breast implant had ruptured. I am hoping my upper back pain goes away and my health recovers. I am cold all the time and my hormones are poorly balanced on their own. endstream endobj 309 0 obj <>stream Link. Besides seeing my primary care physician, i have seen a neurologist, rheumatologist, holistic/functional medicine, gynecologist, dermatologist, psychiatrist, therapist, chiropractor and have tried massage therapy, acupuncture, sauna, and more recently i saw a doctor at (b)(6) for heavy metal issues. Link. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. Link. 11. Fibromyalgia, ms symptoms high blood pressure, chronic fatigue, ibs burning sensation in body, frostbite sensations on outside of my body. Tested positive ana for possible lupus. Link. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. Polycythemia vera rubra. Link. The affected consignees were notified via customer letter on 7/1/16, and a follow-up with respective sales representative via visit. Vitamin deficiency and i take weekly high dosages of vitamin d (50,000) and daily vit d (8,000) and im barely in the normal range. I began having rheumatoid symptoms inflammation, huge knots popping up in various joints, pain on level 10. Then upon investigating, i found that all of my symptoms were related to silicone poisoning due to ruptured implants. Link. the Large Study) have been restructured into multiple smaller studies (Case Control Studies, MemoryGel and Shape Combined Study, Re-Op study). During a bilateral breast augmentation, the implant that was to be used for the right breast was discovered to have/contain foreign material. MENTOR Smooth Round Saline DV Breast Implants (Lot Numbers with Expiration Dates from January 01, 2025 to September 30, 2025) 350-2400 HV]o:}5$[:h{qm:HnE%e:$b`\Y/{h}0mW.9Ri 8RY2 (zWrix{)"j {CDEDJ,$vdTZ + J->5 A>~O,UZkJa]fZ9`=~G7^fcuX# I had smooth mentor memorygel breast implants placed under the muscle 2. It was reported via an fda medwatch form (#mw5072162) that a patient who underwent breast prosthesis implantation with a mentor textured gel device on (b)(6) 2015 was diagnosed with bia-alcl. My physical therapist told me i must maintain an exercise program that he prescribed for me. My doctor said there is nothing that can be done to prevent or fix the deformity once the implants are removed. Feet red swollen to deformity. I have developed severe symptoms over the past two years to include: worsening peripheral neuropathy, muscle/joint/bone pain, and weakness, tremors, dizziness/blackouts, seizures, severe fatigue, mental confusion/forgetfulness, difficulty speaking, went into acute liver failure twice, weakened immune system/recurrent infections, rashes, wounds that wont heal, mood changes, heart palpitations, etc. Left breast had infection both under muscle and within the breast cavity, so implant was removed. The shell is filled with MemoryGel , Mentor's proprietary formulation of medical grade silicone gel, and is constructed of successive cross-linked layers of silicone elastomer. Additional xrays and a great deal of blood work to determine arthritis issues which seem to be taking over my body (was diagnosed as rheumatoid arthritis, but medications have not helped reduce the issues it causes. Team of doctors at (b)(6) clinic couldnt figure out what was happening to me. My implants were under warranty so mentor paid for a new set and most of the surgery. Apparently mentor did not get the message about a ban on implants. Within 6 months of that time frame, i started to have medical concerns, which were unusual for me. f1NW They ranged from fairly benign to increasingly more serious and problematic. SALINE-FILLED MAMMARY PROSTHESES WITH DIAPHRAGM VALVE. 12. Hair loss and dryness, skin dryness and itchiness, dry, brittle flaky nails, extreme sensitivity to cold, night sweat, depression (feeling like the world would be better without me in it), and anxiety. In 2014 i started to get swelling in my fingers and toes. I hurt everyday and have migraines. Link. Her symptoms included rashes, random acne, blackouts to the point the patient stopped driving for safety reasons, severe memory related decline, muscle soreness, extreme fatigue, abnormal thyroid levels, drowsiness, anxiety, and depression. 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Doctor said there is nothing that can be done to prevent or fix the deformity once implants! After the release of Tuftss evidence report the right breast was discovered to have/contain foreign material, implant... Pass, more symptoms seem to be showing up in pain of area of implants as as... Implants removed at the discretion of the radiologist pathology report discretion of the time an and... Active, social, happy, hard-working person a participant from the original large Post-Approval Study MemoryGel...

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