Conclusions: Mentor MemoryGel Silicone Breast implants represent a safe and effective choice for women . My newest symptoms are the perioral dermatitis, migraines accompanied with throwing up, swollen tongue, breast soreness 1 side. For the most part I'm pleased with how they look but unfortunately I'm having the implants removed in two weeks due to autoimmune reactions to them. Swollen hands, tingling in the hands and arms when i bend my joints. 9\?~=4fY[[x|2=(;/QVUTr4( 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. So, i began my research for answers. 2. Link. I have mentor breast implants for reconstruction from cancer 2015. Over the past 3-4 years, the intensity of issues has become severe. Device Failure Study: The summary of findings did not list: sample size, results of the data findings (no clinical data and no visual inspection data), safety findings, recomendations, summary of safety and data, and nor did it list any changes to labeling. I had smooth mentor memorygel breast implants placed under the muscle 2. No money and insurance will not cover? it was a walk in the park! (catalog # 350-7300bc, serial number left side (b)(4) and serial number right side (b)(4)). Patient had implants explanted on (b)(6) 2016. Link. The recall came after the FDA released data in 2019. Sudden decline in health and increase in pain of area of implants as well as systemically. I had mris to check for issues with neck- diagnosed at first as herniated discs but then as arthritis. No further information was obtained. Other diagnosis are for fibromyalgia due to the chronic pain i suffer. Her face started to swell when she got cold. 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. DoNotPay can assist you with a simple, easy-to-use process in one place. They admitted me and performed exploratory surgery, found I had a ruptured right fallopian tube, which they removed. 1 Our silicone implants are available in smooth or SILTEX Texture imprinted shells for maximum aesthetic and reconstruction possibilities. Symptoms: fatigue, endocrine issues, depression, panic attacks, insomnia, joint pain and cognitive dysfunction. I had silicone gel breast implants placed under the muscle. 350-2250 My first symptoms in early 2000 with migraines. Most of the missing silicone was never accounted for, though. Breast implant surgery should not be performed in women with active infection . Link. Mentor textured silicone gel implants. Per patient, the physician woke her up in the middle of the procedure informing her of the discoloration and asked her if he could replace them, therefore the patient underwent bilateral replacement. Tell us how you found out about the recall. Team of doctors at (b)(6) clinic couldnt figure out what was happening to me. Once left breast was opened, implant was ruptured and silicone had settled into the fascia going completely underneath my arm pit and almost to my back. I went from saline smooth implants to textured cohesive gel implants. 5 years ago. Important information: i have been very diligent in following doctors protocols and have preferred diet and exercise over medication if at all possible. 3. The products included in the recall are: Difficulty sleeping, difficulty recalling words (mixing up words), short term memory issues. I researched and found tan excellent plastic surgeon. Link. I then began to have swollen fingers, hands and wrists in (b)(6) of the same year, which led to my being diagnosed with carpel tunnel syndrome by a rheumatologist. From that time on, i developed more and more symptoms that piled on top of each other. I am being treated for this currently. Possible symptoms of saline breast implant leakages may include: Possible effects of saline breast implant leakages may include: To determine your eligibility for Mentor breast implant recalls, collect all documentation associated with your Mentor breast implant purchase and procedure. i no longer had shortness of breath. In 1998, i had a reconstructive surgery and mentor brand, textured, silicone implants were implanted. 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. 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. The implants are scheduled to be removed on (b)(6). it looks like thats what i am coughing up sometimes like i said its extremely sticky. Unexplained rashes, difficulty walking and breathing, pain in my joints, couldnt touch my body. Had breast augmentation in (b)(6) 2013. I had these mentor silicone implants placed in 2007. My last hope was to check these out via breast mri. I have breast implants since 1993. Manufacturer Address Mentor Texas, LP., 3025 Skyway Cir N, Irving TX 75038-3524 Manufacturer Parent Company (2017) Johnson & Johnson Source USFDA Some respondents suggestedthat the true purpose of the brochure was to protect Mentor, rather than inform patients about breast implant surgery. I feel my breasts are ruined forever now. Link. Ringing in ears, metalic taste in mouth, skin rashes bug bites, scratches and other wounds take forever to heal. Learn how. Updated labeling to communicate long-term study results may not be available for all implants in this table. Posting Date. Any ideas what this is? Patient also had delayed wound healing, infection, lymphadenopathy on the left side. In 2016 i had a breast reduction with old implants removed and new implants to put in. H\j@}l/ `t Rheumatologist said i am at high risk for lymphoma. of Irving Texas initiated a recall of their MemoryGel breast implants on July 01, 2016, due to a labeling mix-up, Consignees were notified by mail and a follow-up visit by a sales representative, Hardening of the breast or area around implants, Pain, tenderness, swelling, burning, or numbness. Manufacturer Mentor Texas, LP. Link. Avoid delays that will only cause undue stress, worry, or possibly affect your health by using DoNotPay. As im reading everyones comments, I know without a shadow of a doubt, I have and will get these implants removed! In doing my research, i trusted the fdas recommendation that these were very safe implants. I was diagnosed with hashimotos thyroiditis 3 years ago. 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). The patient must be given the opportunity to initial and sign the patient decision checklist and it must be signed by the physician implanting the device. 800-235-5731. No patient consequences were reported. Her symptoms included rashes, random acne, blackouts to the point the patient stopped driving for safety reasons, severe memory related decline, muscle soreness, extreme fatigue, abnormal thyroid levels, drowsiness, anxiety, and depression. MENTOR MemoryGel Breast Implants, MENTOR MemoryShape Breast Implants, and MENTOR Saline-filled Breast Implants are indicated for breast augmentation in women (at least 22 years old for MemoryGel Implants and MemoryShape Implants, and 18 years old for Saline Implants) or for breast reconstruction. I thank the rheumatologist for validating the fact that the implant could be the cause. 350-1640 Menstrual period only twice or so a year (started in 2008 after implants). 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. Follow instructions in the letter and immediately return any inventory of MENTOR Smooth Round Saline DV Breast Implants with expiration dates ranging from 01/01/2025 to 09/30/2025 subject to this recall to Sedgwick. Mris of brain to check for memory related causes were inconclusive. Memory problems, disturbing enough to affect me emotionally as well. 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! Link. Using DoNotPay for assistance in resolving recall issues other than breast implants is just as easy. My medical bills from this are near (b)(6) and its just not right. Mentor made a decision to file a fda medwatch report based on the above information; however, currently, there is no solid evidence in the literature to suggest that breast implant rupture alter the risk of breast malignancies. A bilateral breast mri was done on (b)(6) 2017 due to recent diagnosis of left breast cancer (exact date of diagnosis is unknown) the mri was done to assess extent of disease and for possible contralateral disease. Mentor Worldwide Historical Implant Data 1985 May 2018. Weight gain, heavy and abnormal menstrual cycles, heart palpitations, chronic diarrhea, muscle cramping/frequent charlie horses, frequent swollen and sore lymph nodes usually under arms sometimes neck, sensitive eyes, enlarged thyroid, allergies for the first time in my life, pain where the ribs meet the sternum. The hospital has denied the mammogram caused the rupture but both at the same time is so obvious. At present, i cannot sit for long, tire easily and cannot drive far. Shame on the implant companies, shame on the FDA and shame on doctors who dont give you enough information!!!!!! 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. Research needs to be done. Loss of interest and pleasure in doing activities. She was scheduled to remove implants the following month. Have heavy metal toxicity and silicone has been found in my lymphnodes of my left armpit and chest wall. FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements (3/19/19). of Irving Texas initiated a recall of their MemoryGel breast implants on July 01, 2016, due to a labeling mix-up Consignees were notified by mail and a follow-up visit by a sales representative Recall terminated December 9, 2016 Symptoms and Side Effects of Defective Breast Implants I have heart issues, fatigue, high metal to city that can lead to significant cardiac issues. Immediately and every day since my surgery 3 weeks ago, ive had all of the same symptoms reappeared but even worse. 5 post implants. A lot of my symptoms have improved or disappeared after removing the implants. 350-2350 Many test to follow. Went through chemo then had a stem cell transplant in (b)(6) 2016. I got severe spinning vertigo that lasted 6 years. Contact the manufacturer if you require additional information. Insomnia, feeling dizzy, or faint, almost blacking out (everything goes dark and i see stars). In July 2019, Allergan was forced to issue a worldwide breast implant recall for its entire line of "Biocell" textured breast implants. 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. I was given iv cipro for several days. My doctor said there is nothing that can be done to prevent or fix the deformity once the implants are removed. I the implants were never soft and felt artificial. Immediately, my breathing was cured! 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). 1. I grew increasingly weaker and more ill. 7. Less than 6 months after having these implants, i started to develop multiple symptoms. I have constant infections. I did not smoke, do not use drugs, do not consume alcohol and eat very clean. Copyright 2016-2022 BreastImplantIllness.com. I had upper back and neck weakness. Link. There i saw my right implant was completely ruptured. The recommendations in this guidance supplement the recommendations in the FDA's Saline, Silicone Gel, and Alternative Breast Implants guidance, issued September 29, 2020 superseding the prior version dated November 17, 2006. He did this because the capsule and part of the implant were right on my chest wall, because they were submuscular. 350-3460. *sOiB'|lC756s7{B6/L5!Szi}VU&K/cUm.zwkeriZH>yOmw6]x2MP7>j|hg@ln5xCi`UD}9' .eEeEeEdfz{=xE^ll`[;;;:888:888:888:888!KbaA0 ,03 Breast implant manufacturers may need to update product labeling as the FDA learns new clinical information. The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates. 39: I also developed severe reactions to some foods. Bia alcl swelling around implant need aspiration. 1 MENTOR Breast Implants are backed 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. 'D))2eYhkE1yj{Y0\. From 2014-2015, some studies (e.g. Instructions for Downloading Viewers and Players. 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). Recent study shows patients and surgeons both preferred the MENTOR MemoryGel BOOST Breast Implant as feeling more like a natural breast versus another leading brand. 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. I could not get a deep breath. It was reported that a (b)(6) female patient with history of breast prosthesis implantations was diagnosed with left breast cancer. I have mentor breast implants that were placed in (b)(6)2007. Hypothyroid, coughing, intolerant to heat and cold, new and persistent viral infections, candida, constant yeast infections. 350-1625 Used in breast reconstruction surgery, MENTOR CPX TM 4 Breast Tissue Expander is designed to expand primarily in the lower portion of the breast, so the resulting pocket will accommodate the implant and slope like a natural looking breast. I have that as well I never thought about any of my issues (lots) having anything to do with my implants in 2017 I would definitely think about taking them out to NOT have the issues / pain Ive dealt with this long. I have been diagnosed with sjogrens, myalgia, low c4 and anemia. No further information is known regarding the patients medical history, status, hospitalizations, medical or surgical interventions that were performed. I was unable to walk or open windows or cupboards. Test (unk) dates but will get. Dry eyes, blurred vision, double vision, and eye pressure. * In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. I have been on prescription medications for those. I received my first set of implants in 2005. 350-1650 I have ulcers on my fingers that will not heal. I have no clue when or how i did this. Pain is intense, particularly in the mornings or after sitting for a while. Link. 3 Difficulty healing (wound etc. ) Informed Decision Study: Overall, this study seemed self-serving to the physicians who are ironically the ones conducting the study on their patients. I had them taken out. This study was revised/replaced into small cohort studies on 10/01/2014. I had mentor silicone implants in 2012. There should be some kind of warning about the dangers of breast implants. Link. I am reporting now in the hopes that eventually these implants will be removed from the market and further restrictions imposed on any implantable device put in the human body. Could barely walk. I have been on a decline in my health since i had implants placed over the muscle in 2000. Had many blood test and i have all of the results. Developed anxiety and uncontrolled vaso-vagal responses. SALINE-FILLED MAMMARY PROSTHESES WITH DIAPHRAGM VALVE. To be able to walk and have energy again, and hopefully for the arthritis symptoms to diminish. q@8mhD";BN"z\h[-1k90p UpK&uEO`W4]76 $gQsB#ZYWG[1!EMd[O'teY3c[UhgE?_u `6 I began having rheumatoid symptoms inflammation, huge knots popping up in various joints, pain on level 10. FDA Determined. This somewhat lessened some of my symptoms but i still felt sick like i was dying slowly. For Additional Information Contact. Pathological evaluation of the patients lymph nodes, removed during the explantation surgery, revealed reactive histiocytosis which is associated with silicone leaking from the prostheses. I was convinced that the implants had ruptured even though it didnt show up. I am researching that option now. After that, i developed pneumonia. 12. Since this event involves device sterility and could have led to an adverse event or serious injury, it is considered serious and mdr reportable. 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. 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. Health deteriorates i lose 25 pounds and blood tests in 2015 suggest cancer. They were smooth, round, and saline, 270 on one side and 300 on the other. 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