I also have become intolerant to smells and chemicals. Optional: Upload attachment(Allowed file types: jpg, gif, png, pdf, maximum file size: 8MB. Within a matter of months, i was already having problems with them the right breast became hard and it wasnt until this year that i had the funds to have them removed. Seven years ago i went from my lovely, natural b-cup to silicone (mentor memory gel) d-cup breasts. Do your research ladies, get a $$ loan if you have to, your health is worth it! Bia alcl swelling around implant need aspiration. The left device was not discolored. The FDA had required this study to be done for 10 years, according to guidelines of the Approval Order in 2006, but the Final Reportwas submitted in year 6 of the study in 2012. Link. I have had nothing but health problems since I got these in plants put in. 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. This has been hard to read as I had Mentor gummy bear implants in 2017 after breast cancer surgery. 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. I have been unable to return to the job that i loved. How the Product Recall Claims product works: And that's it! More than 10 numbers, contact manufacturer. The patient was implanted with mentor smooth round gel mammary prostheses on (b)(6) 2005. Link. So many women are sick and get better after explant. I am so tired of missing out on life due to the way I feel. I began having rheumatoid symptoms inflammation, huge knots popping up in various joints, pain on level 10. Shooting and sharp pain in the breasts. Fibromyalgia, ms symptoms high blood pressure, chronic fatigue, ibs burning sensation in body, frostbite sensations on outside of my body. MENTOR MemoryGel Breast Implants are offered in many sizes and profiles: Moderate Plus, High Profile, Ultra High Profile, Moderate Plus Xtra and High Profile Xtra. I have heart issues, fatigue, high metal to city that can lead to significant cardiac issues. Therefore, in addition to documenting the product description and purchasing information, you should also carefully organize all of the necessary steps required to take advantage of any recall compensations. 350-1655 Both of the implants had holes. Not even a year later i am so ill and in pain i need three surgeries which will not reverse all thats happened. 5 years, she began to suffer from serious health issues, including but not limited to, constant headaches, difficulty with concentration and focusing, constant pain and swelling in left breast, high anxiety, shoulder and neck pain, obsessive compulsive disorder, muscle weakness, symptoms that resembled fibromyalgia, insomnia, memory issues and other symptoms resembling chronic fatigue syndrome. My last hope was to check these out via breast mri. Night sweats. 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). This study was revised/replaced into small cohort studies on 10/01/2014. 12. 10. On (b)(6) 2009 is the date i had surgery to have implants. 350-3290 Patient advised that she had not selected an explant surgeon or explant surgery date as of yet. I am only (b)(6) and should not have any of these health issues. 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. An e. N. T. Dr i went to questioned me about my implants and suggested, i think about having them removed. UT]b$c} Case-Control Study:Terminated. It started with pain, fatigue, numbness, concentration, and memory loss, which has now triggered an autoimmune response and high levels of toxicity in my body. Since explanting, i already am noticing symptoms subsiding such as my brain fog, temperature regulation and ability to focus clearly. 325 0 obj <>/Filter/FlateDecode/ID[<4FD22ED3B7DCE845A6E6AEF3AE0F309B>]/Index[304 37]/Info 303 0 R/Length 103/Prev 225431/Root 305 0 R/Size 341/Type/XRef/W[1 3 1]>>stream 350-3380 r2c=nf"{*!5;/[{8F7)/Z}}o_=T*u 4+ )Z9B I had severe discomfort, pain and burning for over a year!!!! The patient also reported swelling around the implant that needed aspiration. (D4T(']RNk7J I do not know the exact dates off hand. 2*3*2*=JOSTx*=JOMtK7,&a0{\bL+iw]'k Most of the missing silicone was never accounted for, though. 11. DoNotPay can assist you with a simple, easy-to-use process in one place. Manufacturer requested implant and packaging directly from or team to investigate. Unexplained rashes, difficulty walking and breathing, pain in my joints, couldnt touch my body. Finally, the FDA released updated information on the status of breast implant manufacturer post-approval studies. Link. From 2014-2015, some studies (e.g. This past year has been the worst so far and i just explanted without replacing the implants because i am 100% certain they have been poisoning me and i am disgusted how the medical industry does not take these type of complaints seriously. In the past few years i have been suffering from extreme pain in my right breast. In 2012 while leaning over the side of tub, i heard a pop, experienced a sharp shooting pain that went straight thru my left breast. The right had ruptured quite some time ago!!!! q@8mhD";BN"z\h[-1k90p UpK&uEO`W4]76 $gQsB#ZYWG[1!EMd[O'teY3c[UhgE?_u `6 Have had so many tests/labs and everything from chronic fatigue, fibromyalgia, sjogrens, non-specific autoimmune, rashes, brain fog, body aches, night sweats, headaches, muscle weakness, always cold. Cause 2. After gathering all of the relevant information concerning the Mentor saline implants recall, you can begin to take the first steps in making your claim. Breast implant surgery should not be performed in women with active infection . I had the implants removed at the end of 2015. I have been diagnosed with sjogrens, myalgia, low c4 and anemia. 350-2275 Researching implant serial numbers and tracking down your Mentor breast implant provider takes time and effort. Awareness of possible symptoms and side effects resulting from defective breast implants is also relevant for the health and safety of anyone with a Mentor implant. (Unknown if it is Mentor saline or silicone). At least make every day doctors like rheumatologists aware that this is happening, and what can happen if they dont treat it right away. 350-2275. At this point, though, i really just want to feel healthy again and get these toxic bags out!. endstream endobj 312 0 obj <>stream Link. I am cold all the time and my hormones are poorly balanced on their own. Muscle pains and joints. 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. Only effects hip and shoulder joints. Cognition problems, neurological issues. I have mentor breast implants that were placed in (b)(6)2007. My implants were under warranty so mentor paid for a new set and most of the surgery. However, no further information has been made available. Per patient, the physician believes the right device was defective. I am convinced that all of my problems stemmed from the holes in them. MENTOR Breast Tissue Expanders. Have mentor breast implants. Link. 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. I thought maybe an expander that would be placed between the muscle and tissue to push the muscle back down to the chest wall or maybe stitches to stick the muscle back down so that its not pulling the breast tissue when i flex. This generally occurs at the end of the ten-year post approval follow-up period for patients that received the implant during investigational studies and when new post-approval studies are completed. After getting breast implant in (b)(6) 2013, i had hives that lasted a year. 340 0 obj <>stream ], YOgq |2`k''S>L*4'SwxWb^Q(*:P~4}C{e*@6nh(,gey84,px|(JI,C-.k hgt0LIUK~wcHP~YU=Kg2wKE|ytZ$8 Mentor reports this event with an abundance of caution. 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). I have this implant, I had it 4/2017. I went to the er, where they werent sure what was wrong and gave me antibiotics, which had no effect. 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. It helped the pain a bit. Caused autoimmune diseases ana connective tissue diseases. 1* Choose from a wide range of sizes and profiles including Moderate Classic, Moderate Plus, High, and Ultra High. I had silicone gel breast implants placed under the muscle. It is quite difficult to believe that the mentor gel-filled implant was leeching or bleeding toxins into my body to the extent that i was totally debilitated for over 10 months of my life. There is no specific information regarding any diagnoses or symptoms. Dry hair, dry skin, dry mouth, and dry nails. i no longer had shortness of breath. Weight began to plummet, as did blood pressure and just all over general malaise. I asked doctors if it could be my implant and they told me, no. These devices are not safe. I had follow-ups with my surgeon and everything seemed to be fine but the symptoms continue to become worse and more frequent. Link. In 1998, i had a reconstructive surgery and mentor brand, textured, silicone implants were implanted. I am so sick I cant function !!! I know many women do whether they have had autoimmune illness before or not! I hurt everyday and have migraines. They were smooth, round, and saline, 270 on one side and 300 on the other. The health consequences of a ruptured silicone gel breast implant have not been fully established. for Recall. I was diagnosed with alcl in 2016. I am tired all the time despite excellent diet and plenty of exercise. Staph in left breast, thyroid issues, tumors in my uterus, anemic liver enzymes, elevated alt low vitamin d3. endstream endobj startxref I couldnt breathe, thought i have heart attack. Could barely walk. I was shocked as nothing like this was ever heard of in my family. Implants are poisonous. It was reported that a (b)(6) female patient underwent bilateral breast prostheses implantation with mentor gel implants on (b)(6) 2013. 9\?~=4fY[[x|2=(;/QVUTr4( No tumors found despite a positive test for tumor. I am as active as i possibly can be, but lately it has become hard- i am always tired! 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). . Copyright 2016-2022 BreastImplantIllness.com. 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). MemoryGel Breast Implants (Mentor Worldwide LLC, Irvine, Calif.), approved by the U.S. Food and Drug Administration in 2006 for breast augmentation in women aged 22 years and older and for breast reconstruction in women of any age, consist of a single-lumen, round silicone elastomer shell, with a patch on the posterior side, and filled with a cohesive silicone gel. I had a breast augmentation on (b)(6) 2015. After that, i developed pneumonia. (Unknown if it is Mentor saline or silicone). Here are all the ongoing symptoms: migraines, anxiety, fatigue, temperature intolerance, sensitivity to smells, burning pain in breasts, inflammation in breasts, weakness, chronic back pain, whole body dryness, pigment discoloration, blurred vision, word retrieval, concentration, and rapid weight gain. 'D))2eYhkE1yj{Y0\. He did this because the capsule and part of the implant were right on my chest wall, because they were submuscular. This has been a terrible month and year for me. 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. Shoulder and neck pain, pain under my rt rib. Patient was bedridden. 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. Re-Op Study: This studywill collect data when a participant from the original Large Post-Approval Study with MemoryGel breast implants requires a secondary procedure/reoperation. Looking at list of explant doctors and none in my state, neither would insurance cover this out of state or without more serious symptoms as are described here. Had frozen shoulder. 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. Multiple attempts have been made to obtain more event details, however, no additional information has been made available. Link. Site of lymphoma: right side. I started having sensitivity to foods which i never had before and the foods cause pvcs. The hospital has denied the mammogram caused the rupture but both at the same time is so obvious. For example, these implants require a larger surgical incision than saline or less cohesive silicone gel-filled breast implants. hXmo7+br@/M`I8]pqa#yb;7`FERH=:Z+3)5Ii-2ZLyA All symptoms started on the right side of my body, and were more severe than on the left side of my body. Within 6 months of that time frame, i started to have medical concerns, which were unusual for me. Update on the Safety of Silicone Gel-Filled Breast Implants, MemoryShape and MemoryGel Post-Approval Study. I have been ill since having silicone implants fibromyalgia, sleep disorder, pain in neck, shoulders, hips, legs, feet, and back. Link. the Large Study) have been restructured into multiple smaller studies (Case Control Studies, MemoryGel and Shape Combined Study, Re-Op study). Per the medwatch form, extended hospitalization was required. i plan to find out what all i need to take to detox and try to get all this silicone out of my system! Left breast had infection both under muscle and within the breast cavity, so implant was removed. I have not been followed up with after my last post-up appointment in 2010. 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. Gi issues, pain. I had silicone implants put in (b)(6) 2014 and by (b)(6) 2015, i was getting sick. Irvine, Calif., (January 13, 2021) - Mentor Worldwide LLC, the number one global brand in breast aesthetics, and part of . Breast cancer in 2000, so i chose reconstruction with saline implants. To be able to walk and have energy again, and hopefully for the arthritis symptoms to diminish. I started in (b)(6) going to doctor. I have ulcers on my fingers that will not heal. The patient has no family or personal history of breast cancer before this diagnosis. Yet, when i seek the care of specialists, few are able to set a solid diagnosis and i also received clashing diagnosis when seeking second opinions. If you purchased the item online, enter your transaction details and payment method as well. Test (unk) dates but will get. dizziness (light headedness). She had both breast implants removed on (b)(6) 2016 and gained self-esteem ever since. Post-approval studies (PAS) are conditions of device approval. No money and insurance will not cover? 11. Breast implant labeling is provided to ensure a patient receives and understands the benefits and risks of these devices. Instructions for Downloading Viewers and Players. Complex case, a lot going on and they couldnt treat me successfully. 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? 350-3270 Wrong! 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 . 1-800-MENTOR8 (800-636-8678) Monday - Friday, 5:30 a.m. - 5:00 p.m. PST, excluding select holidays Surgery lasted longer than expected due to the difficulty of removing the silicone. I could not get a deep breath. 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