There should be some kind of warning about the dangers of breast implants. The device was given to the manufacturer representative by the or staff for further investigation. In 2006, contacted my plastic surgeon and was told fda had approved a silicone implant for breast cancer patients, so i met with a mentor representative that explained the study i would be required to participate in if i chose these specific implants. a few months later things went downhill fast! I am as active as i possibly can be, but lately it has become hard- i am always tired! For example, these implants require a larger surgical incision than saline or less cohesive silicone gel-filled breast implants. * In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. Within the past 8 months i heard about breast implant illness, i do believe i suffer from it. Since that day ive suffered the following abnormal weight gain, chronic fatigue, brain fog, diagnosed thrush, lack of energy, dry eyes, lack of concentration, dizziness, inflammation, dry skin and hair, estrogen imbalance. in this way, she confirmed that it could be breast implant illness that i was suffering from. 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. Link. I was hospitalized for rapid heart rate and low blood pressure. 2 FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements (3/19/19). I am so tired of missing out on life due to the way I feel. Very weak, couldnt walk a flight of stairs. Scroll down for a list of symptoms women have reported to the FDA and for reports of mastectomy and reconstruction cases, fungus, body parts removed, manufacturer issues, BIA-ALCL, other cancers, and pre and post approval study follow-up. Released from hospital after 5 days. Conclusion on calcifications was bi-rads category: 0- incomplete: needs additional imaging evaluation. This study was revised/replaced into small cohort studies on 10/01/2014. I explanted 3 weeks ago and all my pain is gone. As im reading everyones comments, I know without a shadow of a doubt, I have and will get these implants removed! Its not worth it. Tell us about your purchase, including the product name, brand, store you purchased the item from, price, and date of purchase. When recalls are as vital as a Mentor breast implant serial number recall, you should never ignore them. The hospital has denied the mammogram caused the rupture but both at the same time is so obvious. 350-1610 (Unknown if it is Mentor saline or silicone). Also, gel fracture is a new phenomenon that has been identified for . Immediately, my breathing was cured! The patient felt discomfort which she had not previously experienced. Here are my symptoms: hormones are imbalanced (out of wack), hypothyroid. The shell is filled with MemoryGel, Mentor's proprietary formulation of silicone. The plastic surgeon at (b)(6), removed the implant material by opening up what was left of the capsules rather than using the en bloc method, which is now standard. A lower risk of complication is rupture. My pcp checked all labs and my heart and lungs and everything was normal. Skin issues were addressed with various creams/meds, none which resulted in improvement. I have 3 children and im extremely scared that im going to die from this illness. waiting for scheduled explant and lymphadenotomy when i will be hospitalized. The symptoms are all still there and the issues persist despite medication and extreme lifestyle and diet overhaul. Recalling Firm. Irving TX 75038-3524. Choose whether you want a refund, repair, or replacement. So many women are sick and get better after explant. Link. To be able to walk and have energy again, and hopefully for the arthritis symptoms to diminish. Link. UT]b$c} These issues impact daily. Difficulty swallowing/fullness in throat, decreased libido, low energy, exhausted, weak, memory loss, difficulty concentrating and brain fog. Important information: i have been very diligent in following doctors protocols and have preferred diet and exercise over medication if at all possible. The following section provides links to the approved labeling and the progress of expected labeling supplements. Mri report ((b)(6) 2017) cites patient had augmentation revision procedure in 2008 (no further information stated; no information on types or brand of implants used). Five years of being sick. Link. Using DoNotPay for assistance in resolving recall issues other than breast implants is just as easy. However, i am left with a chronic illness now that most likely will need some medication, supplement, and labs and doctor visits to manage for the rest of my life. Smooth mpp gel mammary prosthesis. I had reconstruction due to breast cancer with mentor memory gel silicone implants 300cc. Immediately after removing the implants began seeing a new dr for help with this who after further lab studies diagnosed me with hashimotos thyroiditis which is an autoimmune disease more than likely caused by the endocrine disruptive toxins in the implants. The patient had a mammogram done on 10/20/2015 that showed some micro calcifications in the left superior breast and recommended patient attempt to obtain prior mammogram images for comparison and for additional imaging (spot magnification views) to evaluate the micro calcifications. Multiple attempts have been made to obtain clarification on catalog, lot number and manufacture site of the devices that were used during this procedure. The fda say they are safe. Within 6 months of that time frame, i started to have medical concerns, which were unusual for me. Patient also had delayed wound healing, infection, lymphadenopathy on the left side. At this point, it had been about 9 months of sustained acute illness. SQ*ONlG7[Gqt9`)/kKJ`%KP\gmht(1IsNeX|J-J|beLYh7uq&%#y6i/UsBA{GxZB5-8nWW!A`y]4M6AbQb&'g*-i!czb@68CsbD6UHpVq hx/Mebx- s. Pathology and currently waiting to explant. Mastitis, cellulitis of the breast. Link. The procedure was completed with different device. They continue to get worse. I am tired all the time despite excellent diet and plenty of exercise. Muscle pains and joints. 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. Through our Product Recalls, all you have to do is tell us about the product you purchased and provide receipts/other evidence, and we'll contact the company on your behalf. Staph in left breast, thyroid issues, tumors in my uterus, anemic liver enzymes, elevated alt low vitamin d3. Two doctors felt there was no rupture!!!! Polycythemia vera rubra. Wound is not healing properly. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruc. I went from saline smooth implants to textured cohesive gel implants. I am hoping i will get better after explanting. Note: If you need help accessing information in different file formats, see Ongoing recurrent infections. 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. After 2nd scar revision surgery, breast tissue was sent for pathology and she was diagnosed with implant-related anaplastic large cell lymphoma on (b)(6) 2017. They ranged from fairly benign to increasingly more serious and problematic. There is no specific information regarding any diagnoses or symptoms. It was reported that packaging for implant sm mpp gel 400cc (p/n: 3504001bc; l/n: 7402435-060) had hole in it. It was reported that memorygel siltex round ultra high 455c (p/n: 3545455; l/n: 7374907-027) had a piece of fiber on it and it did not appear sterile. Link. Informed Decision Study: Overall, this study seemed self-serving to the physicians who are ironically the ones conducting the study on their patients. Was sent to podiatrist and rheumatologist. After revision surgery, the patient experienced delay of wound healing and had two scar revision operations. Link. Link. I noticed it has a Ribble in it, and it has a bubble, the bubble caves in when touched. As of(b)(6) i no longer was able to work. Link. The reoperation incidence for primary augmentation and primary reconstruction was 19.4 and 33.9%, respectively, with explantation and replacement with a study device in 3.9% of primary augmentations and 10.4% of primary reconstructions. After that, i developed pneumonia. (catalog # 350-7300bc, serial number left side (b)(4) and serial number right side (b)(4)). In the event of an unexpected qualifying deflation of a MENTOR Saline-filled Breast Implant, Mentor will replace the product, free of charge, for the lifetime of the patient. I was no longer able to work and was placed on disability. Mentor MemoryGel (Premarket application number: P030053) (Approved November 2006) Description and Detailed Information Links: Mentor's MemoryGel Silicone-Filled Breast Implants have a. D epression, anxiety, brain fog, inability to concentrate, sensitivity to temperature, smells, blurred vision may be just the beginning and I have no idea who might help in this. The implanting surgeon ran a suture through the implant when placing them, they began leaking soon after placement. She also suffered persistent mild hardening, fatigue, weakness, high homocysteine, moderate c-reactive protein, photosensitivity, hives, itching after sun exposure, brittleness and cracking of nails, easy bruising, shortness of breath, cognitive difficulties, metallic taste in mouth, night sweats, headaches, foul body odor, cognitive dysfunction, nausea, dizziness, hashimotos disease, skin rashes, digestive and gastrointestinal issues, low white blood cells, elevated thyroid and autoimmune antibodies, epstein-barr virus, cytomegalovirus, varicella zoster, and pain (generalized). I have been to several doctors and specialists over the year with no help or definite answers. This somewhat lessened some of my symptoms but i still felt sick like i was dying slowly. Fast--You don't have to spend hours trying to solve the issue, Easy--You don't have to struggle to fill out tedious forms or keep track of all the steps involved in solving your problem, Successful--You can rest assured knowing we'll make the best case for you. Ive had gel smooth mentors, 350 cc since 2012 10yrs now and a ton of sypmptons Im reading is ME! Link. Tell us how you found out about the recall. Link. I had mentor silicone implants in 2012. Blurry vision, memory fog, fatigue, numbness in hand and feet, joint pain, urine retention, trouble concentrating, weight gain, ringing in my ears, anxiety, skin rashes, sleep problems, fungus on my rt toe that will not go away and i keep loosing my toe nail. Urine test show protein, my legs, ankles and feet are swelling, still experiencing pain in left wound, hard round know has formed in the center, some swelling remains, as does pain. Immediately and every day since my surgery 3 weeks ago, ive had all of the same symptoms reappeared but even worse. 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. (Unknown if it is Mentor saline or silicone). Since explanting, i already am noticing symptoms subsiding such as my brain fog, temperature regulation and ability to focus clearly. Patient also had developed rashes and pruritis. Have had multiple visits to the ent and walk in clinic. Posting Date. After being implanted with silicone breast implants (cohesive gel by mentor) i became incredibly sick and my body started having a six-year downward spiral of auto-immune issues, endocrine issues, and adrenal dysfunction. k-9(J((5*k?aT/SZ D z:Trx%(o8L?h{C5t*Q Link. They are supposed to last 10 years. Apparently mentor did not get the message about a ban on implants. It was reported that the patient replaced saline implants which was implanted on (b)(6) 2003 with mentor cohesive gel implants in (b)(6) 2011. 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). Link. I know it was the implants pushing on my chest, probably due to the capsular contraction. However, no further information has been made available. Her face started to swell when she got cold. I feel my breasts are ruined forever now. Link. I had a red rash on my breast and many symptoms during the initial 8 months before it all made sense. Core Study:The follow-up rate was 62% at 10 years. MENTOR Breast Tissue Expanders. 350-2300. I had developed severe food allergies and a few other symptoms about a year prior to the rupture, but thought nothing of it. The most common complications for breast reconstruction with MENTOR Saline-filled Breast Implants include re-operation, implant removal, capsular contracture, breast pain, and implant deflation. I have night sweats, i get insomnia, i have a couple different autoimmune diseases that have come about. Breast pain near site of implants was dismissed and then appeased by suggestion to take both vitamin e and evening primrose oils (neither helped reduce pain/discomfort). The product was a silicone gel breast implant. my first ones were removed via the area incision and now i have an incision in the inframammary location. 5. During the last few years, ive had a swollen lymph gland underneath my right arm that repeatedly i was told was benign and nothing to worry about. Link. Link. I just explained and am getting my health back. I will continue to receive services from the occupational therapist and the social worker. 5. It was reported that a (b)(6) female patient underwent breast augmentation revision with mentor gel device on (b)(6) 2011. 2*3*2*=JOSTx*=JOMtK7,&a0{\bL+iw]'k Six months after that surgery the left capsulized; however, surgery was not safe at the time. Bad gastrointestinal and digestive issues, nausea, intense night sweats and hot flashes, poor sleep and insomnia, anxiety and depression. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Risks and Complications of Breast Implants, Medical Device Reports for Systemic Symptoms in Women with Breast Implants, Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma, Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), Things to Consider Before Getting Breast Implants, Breast Implant Postmarket Safety Information, FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants, Breast Implants - Certain Labeling Recommendations to Improve Patient Communication, Saline, Silicone Gel, and Alternative Breast Implants guidance, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders. How the Product Recall Claims product works: And that's it! Also. Researching implant serial numbers and tracking down your Mentor breast implant provider takes time and effort. Link. The site is secure. 1. 3 April 2013. The patient reports that the device was explanted on (b)(6) 2017. Two weeks after getting great implants, lymph nodes began to swell and are still swollen. Irvine, Calif., (January 13, 2021) - Mentor Worldwide LLC, the number one global brand in breast aesthetics, and part of the Johnson & Johnson Medical Devices Companies** today announced that the U.S. Food and Drug Administration (FDA) approved the MENTOR MemoryGel BOOST Breast Implant for breast augmentation in women at least 22 years . Experiencing joint pain, chronic fatigue, brain fog, swollen lymph nodes after mammogram. After approximately 1. i plan to find out what all i need to take to detox and try to get all this silicone out of my system! Ive been reading endless stories online. More than 10 numbers, contact manufacturer. 350-2225 Link. I got breast implants in (b)(6) 2011 within weeks i began feeling aches, pains, fevers, chills, racing heart, hair falling out. I do not smoke cigarettes, and rarely ever drink any alcohol. Fatigue pressure on face (under eyes, around nose) constant headaches, tingling in hands and feet (fall asleep, drop things, difficulty opening things, typing etc). What is your recommendation? I have also been very consistent with all of my medical visits and live a very healthy lifestyle however i continue to become more ill no matter how clean eating, exercising, and taking supplements and medication recommended by physicians. I have had nothing but health problems since I got these in plants put in. No tear or rupture was noted over the years so doctors did not know was diagnosed with lupus in 2015 and have been on thousands of dollars worth of medication the whole time. They admitted me and performed exploratory surgery, found I had a ruptured right fallopian tube, which they removed. This study will combine MemoryShape and MemoryGel patient results. No deflation were found on both devices. Link. I went to the er, where they werent sure what was wrong and gave me antibiotics, which had no effect. Link. In 2017, i chose to have implants removed. SALINE-FILLED MAMMARY PROSTHESES WITH DIAPHRAGM VALVE. On the date listed above, i received breast augmentation with mentor smooth round high profile gel (silicone) implanted ref (b)(4), left lot #6528127, sn # (b)(4) and right lot #5950089, sn # (b)(4). Updated labeling to communicate long-term study results may not be available for all implants in this table. CUwQp.u/p1{Zhi _Sx*51m]`12N}|4}5tR|-\N78G dTYvkr1f|^ok+ s!Q?mNmv4 5YxQbWTw q]fwSb#S~/D:tDJP2FP1U$oM"~\.gB\UU)m+U'zd}D1 X:-BqeI6 \y +@i @PZ/iT>e Tcc13 >VC^% There is original labeling (at the time the FDA approved the implant) and current labeling that is updated with post approval study information and to adequately communicate the risks. Link. Sudden decline in health and increase in pain of area of implants as well as systemically. I was implanted with mentor memory gel silicone breast implants. Migraine headaches, depression, heart palpitations, nausea, and anxiety. I was unable to leave my house unaided from (b)(6) due to this illness. In (b)(6) 2016, the patient underwent surgery and the mentor memory gel implants were removed. I was acutely ill for several months, until the physician who had ordered the mammogram phoned me that something was peculiar on the mammogram film. Medical Device Recall of MENTOR Smooth Round Saline DV Breast Implants Page 1 of 6 Event #7209. (Unknown if it is Mentor saline or silicone). I was extremely healthy at time of the implant surgery and was told these were fda approved and very safe. =h48(!_)L K=%.R0-&S t88/ I was shocked as nothing like this was ever heard of in my family. Caused autoimmune diseases ana connective tissue diseases. She was scheduled to remove implants the following month. Link. Breast implant labeling is provided to ensure a patient receives and understands the benefits and risks of these devices. I had silicone implants put in (b)(6) 2014 and by (b)(6) 2015, i was getting sick. Another said i was an interesting case as tests for memory mostly showed fairly bad short term memory. Adjunct Study Final Report for Mentor's MemoryGel Silicone GelFilled Breast Implants, 02 November 2012. I thank the rheumatologist for validating the fact that the implant could be the cause. The surgeon noticed a piece of plastic that was attached to the outside of the shell. The health consequences of a ruptured silicone gel breast implant have not been fully established. Abnormal blood test results since 2012. Chronic pain, chronic fatigue, cognitive dysfunction (brain fog, difficulty concentrating, word retrieval, memory loss, difficulty processing information), muscle aches, pains, and general weakness, joint pain, dry itchy eyes, easy bruising, loss of sex drive, inability to sexually perform, shortness of breath, night sweats, hormonal imbalances, tingling and numbness in arms, hands and fingers, cold hands and feet, metallic taste in mouth, nail cracking, splitting, no growth, skin freckling, increase in papules, edema, decline in vision, digestive and gastric issues, throat clearing, difficulty swallowing and choking feeling, anxiety, depression, panic attacks. I also thought maybe i wouldnt have all the adverse effects with silicone as i did with saline (thought maybe it was due to mold). Mri confirmed that bilateral implants were ruptured. )7:Evvc},,dK9%"Ty.73&X6H(TQzz?n7?"=O[U? I fortunately found a (b)(6) support group for women with breast implant illness, what i believed to have. i was confronted with a whole host of issues- developed hypothyroidism, adrenal fatigue, hormonal imbalance, irregular periods, candida, 15lb weight gain, fatigue, constant pain in my chest (especially on the rt side), all over muscle soreness, joint pain, hair loss, hair texture changes, strange rashes, heavy legs and swelling, low body temperature, skin elasticity changes, cellulite, muscle loss, brain fog, more food allergies, ibs, and a few vitamin deficiencies. For our MENTOR Breast Implants, if a rupture occurs within 10 years of surgery, you will also be eligible for up to $3,500 in nancial assistance for surgical costs. 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. Currently, diagnosed systemic lupus. I eventually had to remove the left fallopian tube and both ovaries due to the severe pain. Over time since implants. However, no further information has been made available. Then i got very sick in 2012 when i got a diagnosis of polymyalgia rheumatica a crippling autoimmune disease seen in senior adults. I had follow-ups with my surgeon and everything seemed to be fine but the symptoms continue to become worse and more frequent. 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. 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. . Migraines, blurred vision, dizziness, chest pain, gallbladder stopped working without stones, chronic fatigue gastritis, chronic epstein barre, hashimoto thyroid, lyme disease and more. Customer Service. endstream endobj 305 0 obj <>/Metadata 24 0 R/PageLayout/OneColumn/Pages 302 0 R/StructTreeRoot 43 0 R/Type/Catalog>> endobj 306 0 obj <>/ExtGState<>/Font<>/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 307 0 obj <>stream Link. Only need to get an mri if you suspect a rupture or feel contracture. What they are clear about is that i have autoimmune/inflammatory issues in addition to memory issues/brain fog. No further information was obtained. 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