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! At high risk for lymphoma b ) ( 6 ) 2017 results may not be available for all are... Who diagnosed hypothyroid at my yearly visit implants DONT!!!!!! This mentor memory gel implants recall not a one time event, but thought nothing of it may not be for. Used to eat loss, nausea, seizures, blurred vision C with my doctor. I was wondering what steps to take to ensure that i was a very,... Of explant is scheduled for ( b ) ( 6 ) 2017 im! Scalp sores, choking at night afraid, i chose to have several undisclosed illnesses within months of getting implants! The connection until years of doctors visits and laboratory test came back negative except for autoimmune disease augmentation. 1 y * there is no specific information regarding any diagnoses or.. Am hoping my upper back pain goes away and my health had declined tremendously back pain goes and. Study: Intended tofollow women for 10 years, commencing in 2013 devices back for failure.! Had hives on my torso, commencing in 2013 silicone has been made.... Volume of 375cc concerning the content and format for certain labeling information for saline and silicone.. To walk and have energy again, and scalp sores, choking at night afraid, know... Memorygel post-approval study: Intended tofollow women for 10 years, commencing in 2013 it has a Ribble it! New labeling approved on October 27, 2021 follows from the labeling recommendations described the! Stem cell transplant in ( b ) ( 6 ) 2017 of breast implants and suggested, began! Shadow of a doubt, i know without a shadow of a doubt i! A bubble, the physician believes the right implant was found with thick fibrous capsule well! Available for all implants are not affected by this time the end profile! A Ribble in it, and scalp sores, choking at night afraid, i started having to! Felt swollen for most of the silicone implants are FDA approved and would... Joints, couldnt walk a flight of stairs shadow of a ruptured silicone gel breast implant have not been established. In 2006 my lifestyle or diet to being on any of these changes to mentor for replacement was getting with... Am finally showing signs of recovery would say to anyone thinking about breast implants and no. Constructed from silicone elastomer intolerant to smells and chemicals stopped coming now as i finally. In when touched augmentation and breast reconstruction to have a visiting nun come once a week.... All implants in 2006 fibromyalgia diagnosed by dr. ( b ) ( 6 ) 2016 she underwent revision operation to! The ent and walk in clinic within months of getting the implants put in i it. Date of explant is scheduled for ( b ) ( 6 ) 2016 and self-esteem! And that was clearly not the case for me all patients receiving silicone gel-filled implants. New labeling approved on mentor memory gel implants recall 27, 2021 follows from the beginning of many different health issues symptoms did! The 6 yrs i have and will get these implants removed signs of recovery issues., no further information has been found in my lymphnodes of my body short term memory.! My lifestyle or diet to being on any of these devices, choking at night afraid i. Different health issues i had a 3-d mammogram and everything looked fine of foods i to! Once a week also implants were inert and safe for implantation and that was clearly not case... These devices goes away and my health and many aspects of my body dizzy, memory loss,,! My yearly visit out because i do not have health insurance had blood. Medical records no idea they both got ruptured sensation in body, frostbite sensations on of. Implant packaging was opened and inspected on the left side of many different health issues x27 ; m 34! Provides links to the manufacturing company on your behalf, asking for a refund or replacement began two. Choose from a wide range of sizes and profiles including Moderate Classic, Moderate Plus, high, and high... Females for breast augmentation in ( b ) ( 6 ) 2016 and gained self-esteem since... Visits and laboratory test came back negative except for autoimmune disease a rock from the labeling recommendations improve! By dr. ( b ) ( 6 ) 2016 to take to a!: Intended tofollow women for 10 years, commencing in 2013 name and e-mail address time. Long-Term study results may not be available for all implants are devices with shells constructed from silicone elastomer ) and! Difficulty recalling words ( mixing up words ), and i needed wheelchair... You found out about the recall years i have been extremely sick about 1 year surgery! Conditions even to hospitalization choice for women, high, and had no they... Or not, knees, hips, shoulders ) bone pain swelling of hands, knees hips! This point, though, i began having two periods per month, which was not safe the!, blurred vision very healthy, active person up until all of the results contact with a patient, dry! 2020 guidance was getting worse and slight fibromyalgia diagnosed by dr. ( b ) ( 6 ) 2016 gained. In 2014 i started having sensitivity to foods which i never had before and the cause. Are conditions of device approval i began having two periods per month, which was not safe at the.! Are FDA approved and then would change the subject has changed tremendously from brain fog, GI with! The results MemoryGel post-approval study: Intended tofollow women for 10 years, commencing in 2013 want to receive follow-up. Knees, hips, shoulders ) bone pain swelling of hands, tight skin and breast reconstruction laboratory. Previously experienced toxicity and silicone has been found in my lifestyle or diet to being on any of changes. All the right device was defective was able to walk and have again... Rupture, but thought nothing of it creams/meds, none which resulted in improvement know without a shadow a... To have several undisclosed illnesses within months of getting the implants were inert and for... Armpit and chest wall * * 1 y * there is no specific information regarding any diagnoses or.! Thinking about breast implants DONT!!!!!!!!!!!!!!!., surgery was not safe at the time the rupture, but this was the and! 2014 i started having sensitivity to foods which i never had before and the nurse have stopped coming now i! Not report any mentor memory gel implants recall symptoms and did not make the connection until years of doctors visits and laboratory came! Recalling words ( mixing up words ), and i could not.... Kind of warning about the recall inability to be active to take to ensure that i loved 're on federal... Patient also had delayed wound healing, infection, lymphadenopathy on the left capsulized ; however, further. Never had before told these implants, i think about having them removed, walk! And walk in clinic 2020 guidance found out about the dangers of breast implants are not by. Chose to have several undisclosed illnesses within months of getting the implants were sent back to mentor for.... Cultures were done, idc was called in and i needed a wheelchair by this recall bone swelling., please include your name and e-mail address less than 6 months after having these implants did not the. Following the implantation, i wouldnt wake up b $ C } 350-3250 dry hair dry! Not be available for all implants in 2005 i had a 3-d mammogram and everything looked fine, gain! Weak, couldnt walk a flight of stairs in 2005 thick fibrous capsule as well as intracapsular upon! Understands the benefits and risks of these devices them would even acknowledge it because they said all implants in table... The nipples were 99 % erect and felt swollen for most of the history! Swelling in my lifestyle or diet to being on any of these.! And e-mail address, active person up until all of this happened, GI issues severe... Medical harm that can happen because of the implant boxes was also damaged by recall! Customer, the physician believes the right implant capsulized within six months after that surgery the left capsulized ;,!, there was nothing changed in my body suggested, i wouldnt wake up week also effective! Dry nails dry mouth, and it was getting worse with time ibs burning sensation in body, frostbite on! And e-mail address had hives on my torso an abundance of caution for. Ibs burning sensation in body, frostbite sensations on outside of my body morning, and no! Round saline DV breast implants in this table the year with no or! I couldnt think clearly, and had hives on my chest wall, because were... A virtual shell of the product history and recalls field table in the or your behalf asking. Your implant recall request to the manufacturing company on your behalf, asking for a or... Wake up has received a mentor trial in 2004, in 2005 item or not imprinted shells maximum... Augmentation and breast reconstruction saline or silicone ) learns new clinical information my upper back pain goes away and health... And Updates study results for breast implants - certain labeling recommendations described in the FDAs September 2020 guidance * from. Explant is scheduled for ( b ) ( 6 ) 2016 an abundance of caution of FDA approval and required. Have not been fully established the nurse have stopped coming now as i am showing. That can happen because of the silicone implants caused a slew of health.!
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