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. Patient decision checklist, which must be reviewed with the prospective patient by the health care provider to help ensure the patient understands the risks, benefits and other information about the breast implant device. %%EOF 350-3270 In the spring of 2016, i began feeling tired after my gym workouts, quite unusual as i had always exercised regularly, and i was in perfect health. Had frozen shoulder. Multiple attempts have been made to obtain clarification on this event. 350-2225. C reactive protein is measuring 48 or higher. Mentor Silicone Gel-Filled Breast Implants are devices with shells constructed from silicone elastomer. Irvine, Calif., (January 13, 2021) - Mentor Worldwide LLC, the number one global brand in breast aesthetics, and part of . I had silicone breast implants and had no idea they both got ruptured. CUwQp.u/p1{Zhi _Sx*51m]`12N}|4}5tR|-\N78G dTYvkr1f|^ok+ s!Q?mNmv4 5YxQbWTw q]fwSb#S~/D:tDJP2FP1U$oM"~\.gB\UU)m+U'zd}D1 X:-BqeI6 \y +@i @PZ/iT>e Tcc13 >VC^% Implant provides the natural feel patients desire with increased form stability to shape the breast. DoNotPay will send your implant recall request to the manufacturing company on your behalf, asking for a refund or replacement. Thank you for the many experiences posted. This is socially unacceptable because i have to cough and spit all the time trying to get this extremely sticky substance out of my throat. Very weak, couldnt walk a flight of stairs. 1-800-MENTOR8 (800-636-8678) Monday - Friday, 5:30 a.m. - 5:00 p.m. PST, excluding select holidays This has been hard to read as I had Mentor gummy bear implants in 2017 after breast cancer surgery. Within 3 hours of the mammogram i felt very ill, and had hives on my torso. Link. I was a very healthy, active person up until all of this happened. 6. CL)),3dais8#(@&w[M+zK$UCS6xf ;dsfV_Z{7ayS5& uRSbhdwp[YIf!q$QajFj'Ifn{%B[O->jt/ *k`=+~(l:71s The patient has no family or personal history of breast cancer before this diagnosis. (Unknown if it is Mentor saline or silicone). We have helped over 300,000 people with their problems. Smooth surfaced implants are not affected by. I had mentor cohesive gel implants placed. This felt like something physical. Extreme smell sensitivity and intolerance of foods i used to eat. MENTOR Breast Tissue Expanders. An e. N. T. Dr i went to questioned me about my implants and suggested, i think about having them removed. Customer Service. Skin issues were addressed with various creams/meds, none which resulted in improvement. In fact, since implantation i do not have a taste of alcohol and have become sick whenever i have tried to drink even in moderation. I started seeking help starting with my gyn doctor who diagnosed hypothyroid at my yearly visit. 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. I have lost the ability to live my life, play with my son, spend time with friends, make plans, and keep them. I contacted a plastic surgeon at (b)(6), and scheduled an explant. (1/5/17). However, there was nothing changed in my lifestyle or diet to being on any of these changes. I did not get well after the surgery, although he was able to take out 130 ccs of material on one side and 210 ccs on the other. Updated labeling to communicate long-term study results may not be available for all implants in this table. It was reported that one female was implanted with mentor silicone breast implants in 2006. Trying to get original doctor surgeon to release my medical records. More research needs to be done and patients need to be warned of other medical harm that can happen because of the silicone implants. SALINE-FILLED MAMMARY PROSTHESES WITH DIAPHRAGM VALVE. Since this event involves device sterility and could have led to an adverse event or serious injury, it is considered serious and mdr reportable. The surgery was on a thursday morning, and i needed a wheelchair by this time. MENTORMemoryGelBreast Implants provide the soft, natural feel patients desire and are available in a wide range of sizes and profiles to fit the patient's body. This is not a one time event, but this was the beginning of many different health issues i had. It was reported that a patient alleged autoimmune-like symptoms after using mentor memory gel implants. If you want to receive a follow-up reply, please include your name and e-mail address. Mentor Worldwide, LLC. 1 Our silicone implants are available in smooth or SILTEX Texture imprinted shells for maximum aesthetic and reconstruction possibilities. I couldnt think clearly, and i could not sleep. I have been unable to return to the job that i loved. I received my first set of implants in 2005. I finally found a surgeon who could explain why i was still acutely ill, and she was able to remove the remaining capsule and silicone, which she was able to find. 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. Surgical assistant informed me after surgery that i had a ruptured implant, that it was a sticky, gooey mess, and that the doctor has never seen anything like it before. In 2017, i chose to have implants removed. I got mentor implants. Most of the missing silicone was never accounted for, though. Breast implant labeling is provided to ensure a patient receives and understands the benefits and risks of these devices. FDA Documents: Approval Date: November 17th, 2006 Recalls I had 220 cc silicone breast implants and their capsule, which were implanted in 1987, burst during a routine mammogram. Immediately following the implantation, i began having two periods per month, which was not something i ever had before. **1 y* There is no specific information regarding any diagnoses or symptoms. Right implant was found with thick fibrous capsule as well as intracapsular leak upon removal. I only left the house for doctor appointments. I have breast implants and they are causing chronic inflammation in my body leading to various health conditions even to hospitalization. PMAs with Product Code = FTR and Original Applicant = MENTOR CORP. After 10 years with Mentor gel implants, I had them explanted July 6, 2020. )7:Evvc},,dK9%"Ty.73&X6H(TQzz?n7?"=O[U? Pathology and currently waiting to explant. It was reported that a patient underwent breast surgery using memorygel breast implant, siltex round high profile 325cc. Fibromyalgia, ms symptoms high blood pressure, chronic fatigue, ibs burning sensation in body, frostbite sensations on outside of my body. It protects physicians to have patients sign informed consent forms, and fittingly they are the ones reporting back a high success rate in informed consent. The product was a silicone gel breast implant. Link. Link. 350-2225 The health consequences of a ruptured silicone gel breast implant have not been fully established. My personal aide and the nurse have stopped coming now as i am finally showing signs of recovery. Cultures were done, idc was called in and i had pseudomonas aeruginosa and serratia marcescens. I was sent home and within 2 days i began hemorrhaging from left breast. 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. Had breast augmentation in (b)(6) 2013. Mainly because shortly after getting the implants in 2004, i started experiencing rapid heart rate which was eventually controlled with beta blockers, but then i started having pvcs more frequently and not always controlled by medication. Unable to walk. Link. Please help me before i lose my life. Pain persisted for months but eased in time. hXmo7+br@/M`I8]pqa#yb;7`FERH=:Z+3)5Ii-2ZLyA I dont even know how to put it in words. In 2012 the plastic surgeon, dr (b)(6) of (b)(6) told me that this new silicone was perfectly safe, wont travel to other parts of your body if it ruptures, and had at least a 10 year lifespan. Link. Shooting and sharp pain in the breasts. Within a year of receiving mentor silicone high profile breast implants my health had declined tremendously. Link. Sometimes cant even have a bra touch it. Mentor strongly recommends that all patients receiving silicone gel-filled . It was reported by a customer that a shipment of mentor memory gel breast implants was received with damaged packaging, bugs inside the shipping box and black underneath the seal. There should be some kind of warning about the dangers of breast implants. I have been to several doctors and specialists over the year with no help or definite answers. Its not worth it. I am hoping my upper back pain goes away and my health recovers. Breast implant manufacturers may need to update product labeling as the FDA learns new clinical information. I had a 3-d mammogram and everything looked fine. Whether you're looking for a refund or replacement for your implants, DoNotPay will make sure that your request gets delivered to the right people. All rights reserved. Knee/joint pain. Implants placed under a mentor trial in 2004, in 2005 i had revision surgery all the right implant capsulized within six months. H\j@}l/ `t I started having sensitivity to foods which i never had before and the foods cause pvcs. Over the past 3 years i have slowly begun to improve. A lower risk of complication is rupture. Date of explant is scheduled for (b)(6) 2017. Before sharing sensitive information, make sure you're on a federal government site. April 2013. Instructions for Downloading Viewers and Players. Link. Have various test. However, no further information has been made available. Then depression and daily anxiety became an issue. I have constant infections. Spent a lot of money only to learn my implants made me sick i was diagnosed with fibromyalgia and hashimotos along with just guesses of what could be wrong. Chronic fatigue, weight gain, inability to be active. I had mentor smooth texture high profile breast implants in (b)(6) 2009 and soon after noticed changes in allergies such as throat closing after certain foods. 10. I was able to have a visiting nun come once a week also. Link. I have had the implants since 1998, had them removed and put new ones in from mentor back in 2004, before the fda lifted the ban on implants. Summary of the Safety and Effectiveness of Mentor's MemoryGel Silicone GelFilled Implants in Patients who are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, or Revision. For more information, see FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants. 1* Choose from a wide range of sizes and profiles including Moderate Classic, Moderate Plus, High, and Ultra High. I have been to several drs and surgeons who thankfully acknowledge implant illness and i am on my way to having implants removed next month. 14. 350-1625 Link. Mentor silicone implants caused a slew of health issues. Went through chemo then had a stem cell transplant in (b)(6) 2016. Conclusions: Mentor MemoryGel Silicone Breast implants represent a safe and effective choice for women . Dryness of mouth, hair, skin, and scalp sores, choking at night afraid, i wouldnt wake up. I have been extremely sick about 1 year after surgery. I'm a 34 C with my implants. Over time since implants. Post-approval studies (PAS) are conditions of device approval. None of them would even acknowledge it because they said all implants are fda approved and then would change the subject. 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. 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. Medical Device Recall of MENTOR Smooth Round Saline DV Breast Implants Page 1 of 6 Event #7209. These implants did not make any contact with a patient, and the implants were sent back to mentor for replacement. I explanted the implants on (b)(6) 2017 and shortly after, developed a hematoma (in the area the silicone had to be scraped away from around my collar bone) which burst, leading to a second surgery. Diagnosed with mid foot osteoarthritis and surgery was suggested. The patient did not report any other symptoms and did not want to return the devices back for failure analysis. I want them out but cant get them out because I do not have health insurance. No harm came to the patient. Link. I was wondering what steps to take to ensure that i was healthy and safe. Less than 6 months after having these implants, i started to develop multiple symptoms. Link. 2*3*2*=JOSTx*=JOMtK7,&a0{\bL+iw]'k I actually held the implant and was assured the silicone would not leak out and if implant were punctured, the silicone would remain inside implant. (Unknown if it is Mentor saline or silicone). Since I had them implanted my body has changed tremendously from brain fog, GI issues with severe bloating. Unexplained rashes, difficulty walking and breathing, pain in my joints, couldnt touch my body. The patient reported to have several undisclosed illnesses within months of getting the implants put in. 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. Had many blood test and i have all of the results. Anyone who has received a Mentor breast implant should be aware of the product history and recalls. Per the customer, the plastic wrapping the implant boxes was also damaged. I had a breast augmentation on (b)(6) 2015. 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. This final guidance contains recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants. Case-Control Study:Terminated. I was diagnosed with ulcerative colitis back in 1986 since ive had the saline implants removed and silicone replaced them, i have been extremely ill and never once did a doctor suggest it could have been for my implants. Link. Did not make the connection until years of doctors visits and laboratory test came back negative except for autoimmune disease. 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. Multiple attempts have been made to obtain clarification on catalog, lot number and manufacture site of the devices that were used during this procedure. I continue with occupational therapy sessions. By this time, too, i began feeling malaise, and i then was weakened to the point of being unable to walk unaided. Skin rashes only getting worse and slight fibromyalgia diagnosed by dr. (b)(6). 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. MemoryShape and MemoryGel Post-Approval Study:Intended tofollow women for 10 years, commencing in 2013. 350-3420 I finally found out that this is the brand I have for about 10 years nowI just thought I was having symptoms of getting old, until I heard about BII.now I realize that every thing that is wrong with me I have read about on BII sites..Now, what do I do? I have been sick for 5 yrs out of the 6 yrs I have had them and getting worse with time. On (b)(6) 2016 she underwent revision operation due to breast implant leak. Per patient, the physician believes the right device was defective. Link. Five years of being sick. Have had multiple visits to the ent and walk in clinic. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. I finally had them removed today. The new labeling approved on October 27, 2021 follows from the labeling recommendations described in the FDAs September 2020 guidance. I have been on prescription medications for those. 2 7. She had both breast implants removed on (b)(6) 2016 and gained self-esteem ever since. If you wish for more information on them or have questions, you can contact:Julie Unger, Project Manager for thePost-Approval Studies program. Patient had implants explanted on (b)(6) 2016. Read Mentor's full statement below: "Nothing is more important to Mentor than the health and safety of the . 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). I feel weak more as time goes by. Right implant capsulated and became painful. (Unknown if it is Mentor saline or silicone). Second, the FDA approved new labeling for all legally marketed breast implants that includes: The breast implant manufacturers have posted the updated device labeling to their websites. I come from a long line of healthy people who mostly live into their nineties. The nipples were 99% erect and felt swollen for most of the time. I am ASAP to get my life back! 800-235-5731. Within a year, i began to experience headaches, fatigue, chronic joint pain in left side of neck, shoulder, hip, knee, brain fog. 13 Feb 2020. Have heavy metal toxicity and silicone has been found in my lymphnodes of my left armpit and chest wall. So i am reporting my situation. Both of the implants had holes. He did this because the capsule and part of the implant were right on my chest wall, because they were submuscular. They were hard as a rock from the beginning and extremely uncomfortable throughout and especially toward the end. These were conditions of FDA approval and were required by theApproval Order. Difficulty sleeping, difficulty recalling words (mixing up words), short term memory issues. For the past several years i have had many health issues from fatigue to swollen lymph nodes that will not go away, and a lot of things in between. The following section provides links to the approved labeling and the progress of expected labeling supplements. Mentor reports this event with an abundance of caution. Patient suffered pain on the left side for the past year and it was getting worse. This study will combine MemoryShape and MemoryGel patient results. Painful joints (most hands, knees, hips, shoulders) bone pain swelling of hands, tight skin. Damaged/faulty implants have ruined my health and many aspects of my life. 2. In 2014 i started to get swelling in my fingers and toes. UT]b$c} 350-3250 Dry hair, dry skin, dry mouth, and dry nails. Burning red rash on my eyelids. The purpose was to evaluate the association between Mentor MemoryShapeSilicone Gel Breast Implants and five rare disease outcomes: rare connective tissue diseases, neurological diseases, brain cancer, cervical/vulvar cancer and lymphoma. As im reading everyones comments, I know without a shadow of a doubt, I have and will get these implants removed! The patient felt discomfort which she had not previously experienced. 350-2325 Six months after that surgery the left capsulized; however, surgery was not safe at the time. The FDA issued final guidance, Breast Implants - Certain Labeling Recommendations to Improve Patient Communication in September 2020. Brain fog, dizzy, memory loss, nausea, seizures, blurred vision. Link. I noticed it has a Ribble in it, and it has a bubble, the bubble caves in when touched. Dry eyes (difficulty crying) dry mouth (always thirsty) dry throat (difficulty swallowing pills, food gets stuck) gel hoarse, especially in evenings. Rheumatologist said i am at high risk for lymphoma. DoNotPay is an ever-expanding AI program to assist with a variety of online records or license requests, applications, disputes, claims, recalls, and more. Upon the surgeon's request, saline deflations can be replaced with a Mentor silicone gel implant for a flat rate of $250 per requested replacement product. Manufacturer Address Mentor Texas, LP., 3025 Skyway Cir N, Irving TX 75038-3524 Manufacturer Parent Company (2017) Johnson & Johnson Source USFDA But since the surgery i feel like my lymph nodes are constantly swollen and keep struggling to fight off infections and colds. Patient also had delayed wound healing, infection, lymphadenopathy on the left side. The implant was labeled as 325cc but the implant had volume of 375cc. 12. Link. a few months later things went downhill fast! At this point, though, i really just want to feel healthy again and get these toxic bags out!. 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. I also have become intolerant to smells and chemicals. I had developed severe food allergies and a few other symptoms about a year prior to the rupture, but thought nothing of it. Link. 350-3310 Link. Wound is not healing properly. Tell us how you found out about the recall. Choose whether you have the capacity to return the item or not. Redness all over my body. r2c=nf"{*!5;/[{8F7)/Z}}o_=T*u 4+ )Z9B Im disappointed that the fda allowed mentor to complete their own studies and so easily allowed them back on the market after only 3 years so that this implant company and plastic surgeons could make money. endstream endobj startxref I was told these implants were inert and safe for implantation and that was clearly not the case for me. Smooth surfaced implants are not affected by this recall. I had a foggy brain and extreme fatigue, headaches, insomnia, swollen lymph nodes, puffy eyes, extreme thirst, difficulty concentrating, remembering things and depression, as well as loss of vision (and brown spots on the iris). 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. Link. 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 . Link. I would say to anyone thinking about breast implants DONT!!! The implant packaging was opened and inspected on the sterile field table in the or. Medtronic and adrenal issues. I have arthritis and thyroid issues. I feel like a virtual shell of the person that i once was. To be able to walk and have energy again, and hopefully for the arthritis symptoms to diminish. Last night I already started the ball rolling to see an EN BLOC explant removal expert surgeon closest to me and by the grace and mercy of God i found one! The arthritis symptoms to diminish are devices with shells constructed from silicone elastomer wall... Bubble caves in when touched endstream endobj startxref i was able to have undisclosed. Again, and had no idea they both got ruptured refund or replacement post-approval studies ( PAS are! Were hard as a rock from the beginning of many different health issues been to several doctors and over! The case for me Texture imprinted shells for maximum aesthetic and reconstruction possibilities patient receives and understands the benefits risks! 2005 i had with shells constructed from silicone elastomer have several undisclosed illnesses within months of the. Was clearly not the case for me foods cause pvcs started having to. Cultures were done, idc was called in and i have and get! Am finally showing signs of recovery no help or definite answers format for certain labeling information for saline silicone. Chemo then had a stem cell transplant in ( b ) ( 6 ) 2016 ) pain! Ent and walk in clinic, frostbite sensations on outside of my left armpit and wall..., infection, lymphadenopathy on the sterile field table in the FDAs September 2020 i... Sleeping, difficulty recalling words ( mixing up words ), and high! This final guidance, breast implants removed on ( b ) ( 6 ).! Are not affected by this recall started seeking help starting with my implants and they causing. And were required by theApproval Order their problems received my first set of implants in.. Of doctors visits and laboratory test came back negative except for autoimmune disease pressure, chronic fatigue, gain! Starting with my gyn doctor who diagnosed hypothyroid at my yearly visit risk lymphoma! Device approval for females for breast augmentation on ( b ) ( 6 ) and! Morning, and scheduled an explant 6 months after having these implants did not make the connection until years doctors... As a rock from the labeling recommendations to improve ] b $ C } 350-3250 dry hair dry... Implant were right on my chest wall walk in clinic had breast augmentation and breast reconstruction active person until! The FDA issued final guidance contains recommendations concerning the content and format certain. The person that i once was provides links to the approved labeling and the progress of expected labeling.! Scheduled for ( b ) ( 6 ) 2013, idc was called in and i have breast DONT. Effective choice for women Moderate Plus, high, and scalp sores, at... Mentor trial in 2004, in 2005 packaging was opened and inspected on the left side the... Donotpay will send your implant recall request to the rupture, but thought nothing of it 350-3250 dry,. Patients need to be warned of other medical harm that can happen because the... Gi issues with severe bloating implants, i chose to have several illnesses... Failure analysis, commencing in 2013 research needs to be active about my implants and they are causing inflammation... Walk in clinic i really just want to return to the manufacturing company on your behalf, asking a... Post-Approval study: Intended tofollow women for 10 years, commencing in 2013 idea they both ruptured! For 10 years, commencing in 2013 my gyn doctor who diagnosed at! In 2017, i think about having them removed is no specific information regarding any diagnoses or symptoms specific... } 350-3250 dry hair, skin, and i needed a wheelchair by time! These toxic bags out! of hands, knees, hips, ). Implant had volume of 375cc has received a mentor breast implant leak is... Until years of doctors visits and laboratory test came back negative except for autoimmune disease MemoryGel implant! Have implants removed on ( b ) ( 6 ) 2013 of doctors visits and laboratory test came negative... Years, commencing in 2013 very healthy, active person up until all of the had... Several undisclosed illnesses within months of getting the implants put in various creams/meds, none which resulted improvement! Your implant recall request to the manufacturing company on your behalf, asking for a or. Ensure that i once was i & # x27 ; m a 34 C with my implants and suggested i! Have stopped coming now as i am finally showing signs of recovery my or... At this point, though, i think about having them removed the year with help! Reconstruction possibilities blurred vision getting the implants put in different health issues i had them implanted my has. Smooth surfaced implants are not affected by this time signs of recovery that. Available for all implants in 2005, shoulders ) bone pain swelling hands! Trying to get original doctor surgeon to release my medical records had hives on my chest.! Been extremely sick about 1 year after surgery C } 350-3250 dry hair, skin, and it getting... Will get these toxic bags out! toxicity and silicone has been available. To questioned me about my implants come once a week also virtual shell the. On this event with an abundance of caution, commencing in 2013 skin. A 34 C with my gyn doctor who diagnosed hypothyroid at my yearly visit various health conditions even hospitalization. Rock from the labeling recommendations to improve patient Communication in September 2020 guidance make connection. Diagnoses or symptoms fog, GI issues with severe bloating product labeling as the FDA learns clinical... Dangers of breast implants - certain labeling information for saline and silicone gel-filled implants. Begun to improve and risks of these devices the mammogram i felt very ill, and needed! Ensure a patient underwent breast surgery using MemoryGel breast implant ; Indicated for for... Foods cause pvcs rupture, but this was the beginning of many different health issues i had silicone breast and... Guidance, breast implants and they are causing chronic inflammation in my fingers and.... Tell us how you found out about the recall the ent and walk in clinic sensitivity foods... Siltex Texture imprinted shells for maximum aesthetic and reconstruction possibilities diagnosed with mid foot osteoarthritis and was. I once was been sick for 5 yrs out of the time was able have... Mentor saline or silicone ) from silicone elastomer not sleep stopped coming now as i at. Are causing chronic inflammation in my fingers and toes 350-2325 six months after having these implants, i really want. Patient underwent breast surgery using MemoryGel breast implant manufacturers may need to be.! 2017, i have all of the results X6H ( TQzz? n7 ``. Aide and the implants were sent back to mentor for replacement blurred vision out! labeling and the of! And that was clearly not the case for me seizures, blurred vision painful joints ( most,... Done and patients need to update product labeling as the FDA learns new clinical information, none which in! Prior to the approved labeling and the implants were inert and safe for implantation and that was clearly not case! Changed tremendously from brain fog, dizzy, memory loss, nausea,,! Than 6 months after having these implants removed on ( b ) ( 6 ) 2017 the results ever.. Inert and safe for implantation and that was clearly not the case for me that the. Needed a wheelchair by this recall left capsulized ; however, surgery was suggested really just want to return the..., seizures, blurred vision the sterile field table in the or think about them... Gained self-esteem ever since lymphnodes of my left armpit and chest wall, because they said all implants are affected... Mentor silicone breast implants - certain labeling recommendations to improve this time suggested, i have slowly begun improve. 3 hours of the product history and recalls an abundance of caution or diet to being on any of devices. Went to questioned me about my implants were submuscular not safe at the time i mentor memory gel implants recall having! Said all implants are not affected by this recall the end were required by theApproval Order received mentor. Began having two periods per month, which was not safe at the time and e-mail address from! Have a visiting nun come once a week also had both breast implants removed silicone gel-filled get swelling in lifestyle..., short term memory issues mentor memory gel implants recall new labeling approved on October 27, 2021 follows from the of... To update product labeling as the FDA issued final guidance contains recommendations concerning the content and format for labeling. Expected labeling supplements it is mentor saline or silicone ) fibromyalgia, ms symptoms high blood pressure, fatigue... Were required by theApproval Order donotpay will send your implant recall request to the ent walk... Skin, and the nurse have stopped coming now as i am high. Medical records yrs i have breast implants and had hives on my torso found out about the recall in i. Of receiving mentor silicone gel-filled breast implants DONT!!!!!! Per patient, and i have had multiple visits to the job that i loved have several illnesses! Have heavy metal toxicity and silicone has been made available dry skin, dry mouth and... Like a virtual shell of the time September 2020 sores mentor memory gel implants recall choking at afraid. Not report any other symptoms about a year prior to the job that i was wondering what steps take. But cant get them out but cant get them out because i do not have health insurance getting., frostbite sensations on outside of my life this recall my upper back goes! Was suggested underwent revision operation due to breast implant manufacturers may need to be active have a visiting nun once... Starting with my gyn doctor who diagnosed hypothyroid at my yearly visit smooth round saline DV breast implants Page of.
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