It behave with extreme fatigue and has increasingly gotten worse. Smooth surfaced implants are not affected by. Upon further inspection of the inner shell, the surgeon noticed black specs floating in the fluid. The nipples were 99% erect and felt swollen for most of the time. My upper body muscles ache, and i continue to have difficulty sleeping. Eventually by 2007 both implants were capsulized. Implants robbed me of a year of my life!. I want them out but cant get them out because I do not have health insurance. I experienced horrific pain, consulted with pcp who ordered x-rays that showed no rupture. I had the breast implants removed on (b)(6) 2015 and began the process of detoxing the chemicals and heavy metals that are in silicone gel breast implants. Researching implant serial numbers and tracking down your Mentor breast implant provider takes time and effort. In 2019 I started experiencing severe lower abdominal pain that sent me to the emergency room several times. No patient information (name, phone number, email, date of birth) was provided, therefore no follow up was completed, and there is no additional information available. Ive been to the doctor many times complaining about the lymph gland being swollen and getting dismissed repeatedly, i could really use to use some advice or support. Manufacturer Mentor Texas, LP. Link. Pathology and currently waiting to explant. It was reported that one female was implanted with mentor silicone breast implants in 2006. 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. Sit back and relax while we do the work. Migraines, blurred vision, dizziness, chest pain, gallbladder stopped working without stones, chronic fatigue gastritis, chronic epstein barre, hashimoto thyroid, lyme disease and more. The surgeon seemed to do an adequate procedure of placing the implants back in (b)(6) 2014. I have been ill for past several years with autoimmune illness. Link. I am tired all the time despite excellent diet and plenty of exercise. Manufacturer site is unknown. 350-2400 I was later diagnosed with postural orthostatic tachycardia syndrome and placed on metoprolol. Since that date my health has steadily declined with a fast decline noted after 2. The shell is filled with MemoryGel, Mentor's proprietary formulation of silicone. Dryness of mouth, hair, skin, and scalp sores, choking at night afraid, i wouldnt wake up. 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). Tell us how you found out about the recall. Gi issues, pain. Link. The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates. I am cold all the time and my hormones are poorly balanced on their own. After several years of pain and discomfort and being diagnosed with sjogrens syndrome, lupus, arthritis, fibromyalgia, high blood pressure, my plastic surgeon recommends the removal of my implants. I was diagnosed with hashimotos thyroiditis 3 years ago. 350-2300. . I have been having vision problems, extreme fatigue, muscle pain, back and neck pain, hearing problems, foggy brain, stomach and intestinal issues, sore throat and cant swallow, swelling in joints and distorted looking breasts. Note: If you need help accessing information in different file formats, see The procedure was completed with different device. In March they took out my perfectly normal appendix, I remained in the hospital for two weeks after that surgery where I gain nearly 20 pounds in water weight and swelling, with severe abdominal pain. 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. The surgery was on a thursday morning, and i needed a wheelchair by this time. I could not raise my arms, move my legs or use my hands. I only left the house for doctor appointments. FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements (3/19/19). What they are clear about is that i have autoimmune/inflammatory issues in addition to memory issues/brain fog. At this point, though, i really just want to feel healthy again and get these toxic bags out!. I received my first set of implants in 2005. I had a 3-d mammogram and everything looked fine. Link. From 2014-2015, some studies (e.g. 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. 9\?~=4fY[[x|2=(;/QVUTr4( endstream endobj 309 0 obj <>stream I had a red rash on my breast and many symptoms during the initial 8 months before it all made sense. 350-2225 Its never been ending and i cant get medical assistance to have them removed. Mentor Worldwide, LLC. Began with pain in joints/muscles of the neck, led to other infections and weakened immune system, followed by growing pain in joints and extreme fatigue. 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 actually held the implant and was assured the silicone would not leak out and if implant were punctured, the silicone would remain inside implant. Updated silicone gel-filled breast implant rupture screening recommendations. Health deteriorates i lose 25 pounds and blood tests in 2015 suggest cancer. A lower risk of complication is rupture. I began using a cane, then a walker, and eventually had to be pushed in a wheelchair. Six months after implants got (b)(6), along with unexplained weight loss, reoccurring shingles, and fatigue. 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. This began to get out of hand this (b)(6) and i began to research to figure out what was going on. Often, people will ignore or pass up opportunities for compensation for these faulty products. 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. Was sent to podiatrist and rheumatologist. First, the FDA issued orders restricting the sale and distribution of breast implants to help ensure that patients considering breast implants are provided with adequate risk information so that they can make fully informed decisions. Caused autoimmune diseases ana connective tissue diseases. 6. Link. 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. 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). 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. 350-2225. MemoryGel breast implants come in either a textured or smooth surface shell and are available in a wide range of sizes and profiles to fit your body. I had silicone breast implants from mentor in 2013. Ringing in ears, metalic taste in mouth, skin rashes bug bites, scratches and other wounds take forever to heal. 12. We have helped over 300,000 people with their problems. Irving TX 75038-3524. 10. All rights reserved. Link. a few months later things went downhill fast! FDA Documents: Approval Date: November 17th, 2006 Recalls Link. I explanted 3 weeks ago and all my pain is gone. Cognition problems, neurological issues. Medical Device Recall of MENTOR Smooth Round Saline DV Breast Implants Page 1 of 6 Event #7209. Link. I was shocked as nothing like this was ever heard of in my family. Link. I have had 5 surgeries for shoulders and 2 on my hands. 350-2250 In 2006, contacted my plastic surgeon and was told fda had approved a silicone implant for breast cancer patients, so i met with a mentor representative that explained the study i would be required to participate in if i chose these specific implants. I could no longer get out of bed and had to have assistance bathing and dressing. Large Study:The follow-up rate was 20.1% at 7 yearsand the final report is on year 9 in 2015. Check out a few examples of the ways we can assist you with these difficult tasks. Neck, shoulder pain along with tension on where my head and spine meet. 2*3*2*=JOSTx*=JOMtK7,&a0{\bL+iw]'k Link. 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. I come from a long line of healthy people who mostly live into their nineties. This is the date of my first cardiac ablation for persistent premature ventricular contractions (pvc). I believe as i stated before they have exacerbated my autoimmune challenges. I hadnt been contacted for several months because the breast tissue itself looked normal. I also had low levels of magnesium, vit d, zinc and other minerals as well, has fluctuations of female hormones. 5 post implants. They continue to get worse. I had mentor silicone breast implants in (b)(6) 2007. Link. 10Year Core Gel Final Clinical Study Report. Migraine headaches, depression, heart palpitations, nausea, and anxiety. The implant was removed from the field and a new implant was used for the procedure. I had reconstruction due to breast cancer with mentor memory gel silicone implants 300cc. 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. The patient felt discomfort which she had not previously experienced. Link. Due to memory issues and based on disclosure of history only, one doctor diagnosed dementia. Vitamin deficiency and i take weekly high dosages of vitamin d (50,000) and daily vit d (8,000) and im barely in the normal range. Read Mentor's full statement below: "Nothing is more important to Mentor than the health and safety of the . MENTOR Breast Tissue Expanders. Auto immune disease, hands were swollen, red, and itchy. No reports of rupture or other product issues. 350-2325. I was unable to leave my house unaided from (b)(6) due to this illness. 350-3380 Alcl stage and alcl treatment are unknown. i no longer had shortness of breath. Link. I had these mentor silicone implants placed in 2007. I am convinced that all of my problems stemmed from the holes in them. Immediately following the implantation, i began having two periods per month, which was not something i ever had before. If you want to receive a follow-up reply, please include your name and e-mail address. My newest symptoms are the perioral dermatitis, migraines accompanied with throwing up, swollen tongue, breast soreness 1 side. Hair thinning and lost. At this point, it had been about 9 months of sustained acute illness. 800-235-5731. I was hospitalized for rapid heart rate and low blood pressure. I am hoping my upper back pain goes away and my health recovers. Case-Control Study:Terminated. Besides developing multiple food sensitivities, i have also developed an extreme sensitivity to mold and chemical exposure. Multiple symptoms continue. It was reported that (b)(6) the female patient underwent primary breast augmentation surgery using mentor gel implants in 2000. it looks like thats what i am coughing up sometimes like i said its extremely sticky. I would say to anyone thinking about breast implants DONT!!! 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. 350-3330 I started becoming ill after a few months. More than 10 numbers, contact manufacturer. Arthritis in my hands, swollen feeling, vision issues, hypothyroid, hashimoto, crepe like/dry skin. 5. I had memory gel under the muscle about 10 years ago. hXmo7+br@/M`I8]pqa#yb;7`FERH=:Z+3)5Ii-2ZLyA She had both breast implants removed on (b)(6) 2016 and gained self-esteem ever since. April 2013. 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). These implants did not make any contact with a patient, and the implants were sent back to mentor for replacement. Have mentor breast implants. This is so my body can have an opportunity to try and heal and settle down from all of the reactions my body is experiencing. Difficulty sleeping, difficulty recalling words (mixing up words), short term memory issues. Smooth mpp gel mammary prosthesis. 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. Link. Link. Over the past 3-4 years, the intensity of issues has become severe. Link. It was reported via an fda medwatch form (#mw5072162) that a patient who underwent breast prosthesis implantation with a mentor textured gel device on (b)(6) 2015 was diagnosed with bia-alcl. This is five years of my life i cant get back. Brain fog, memory loss, muscle pain, weakness, joint pain, dizziness. Diagnosed with mid foot osteoarthritis and surgery was suggested. Another said i was an interesting case as tests for memory mostly showed fairly bad short term memory. It is unknown where and how the issue occurred. I have this implant, I had it 4/2017. 3. The implant packaging was opened and inspected on the sterile field table in the or. Conclusions: Mentor MemoryGel Silicone Breast implants represent a safe and effective choice for women . Just came across the breast implant illness. So, i had the surgery to replace them and it was an absolute breeze! Complex case, a lot going on and they couldnt treat me successfully. I have constant infections. Implants should be taken off the market, they are so hazardous to our health. 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? Over the past 3 years i have slowly begun to improve. Medtronic and adrenal issues. 350-2275. Two major issues, deformity and a rare autoimmune disease seen in much older adults. No further information was available. Only effects hip and shoulder joints. 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. After doing research on my own and some common sense. 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. No contact information was provided in mw report, therefore no further information has been made available. Mentor is commited to product safety. I have been extremely sick about 1 year after surgery. Memory problems, disturbing enough to affect me emotionally as well. Mentor implant recalls, unlike other recalls, may require multiple doctor's visits and even surgery. Link. Swollen hands, tingling in the hands and arms when i bend my joints. Link. 350-3460. It has been a year of feeling acutely ill. Then in 2011, i was diagnosed with a rare blood cancer. 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. I asked doctors if it could be my implant and they told me, no. endstream endobj startxref 3 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. 39: They were very ripply as well. When recalls are as vital as a Mentor breast implant serial number recall, you should never ignore them. I finally had them removed today. Extreme hair loss that has created balding (alopecia) on my scalp. Link. I was able to have a visiting nun come once a week also. After getting breast implant in (b)(6) 2013, i had hives that lasted a year. 10. In 2016 i had a breast reduction with old implants removed and new implants to put in. I continue to have swelling in my hands and weakness in my upper arms, neck and back. I suffered from extreme fatigue, and my joints were swollen, especially my right knee. Shortly after, i began to experience a myriad of unexplained symptoms including anxiety, thyroid levels off, debilitating fatigue, dry eyes, blurred vision, brain fog, dizziness, etc. Wound is not healing properly. 350-3250 In (b)(6) 2014, both ruptured implants, damaged lymph nodes, affected chest muscle, and surrounding tissue (to my chest wall) were removed during a 7 hour surgery. Redness all over my body. 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. The fda say they are safe. The rheumatologist took blood tests and results showed i had an autoimmune disease known as scleroderma. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. 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. These were conditions of FDA approval and were required by theApproval Order. After approximately 1. No money and insurance will not cover? Link. Link. Tell us about your purchase, including the product name, brand, store you purchased the item from, price, and date of purchase. I have been on prescription medications for those. Ive been reading endless stories online. Link. Night sweats. I have pictures, notes and many bills. Then i got very sick in 2012 when i got a diagnosis of polymyalgia rheumatica a crippling autoimmune disease seen in senior adults. Extreme fatigue, loss of concentration, memory loss, along with brain fog, confusion and cognitive dysfunction. %PDF-1.7 % I have chronic candida overgrowth hormone fluctuations, chronic fatigue, various gut issues, digestion problems. In (b)(6) of 2016 the implants were explanted and reported to be filled with mold. I am so tired of missing out on life due to the way I feel. Link. The changes i have had in my body in the past 15 months have been so drastic for me. Case-control studies were later terminated after the release of Tuftss evidence report. I am ASAP to get my life back! 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. I was a 34 B previously. I decided to try silicone this time because they are supposed to be softer and i figured they would not press on my chest and make it hard to breathe. 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. I have experienced fatigue, joint pain (hips), muscle soreness, red and sore eyes, weight gain, inability to take deep breaths, inability to lose weight , double vision and trouble recalling words. I started in (b)(6) going to doctor. I feel weak more as time goes by. Up until getting implants i never had any significant health problems. Lymphedema, autoimmune disease, anemia, permanent muscle and nerve damage, silicone and heavy metal poisoning, loss of appetite, vomiting pain, blood and fluid build up around implants, pain in joints, dizziness, brain fog, confusion, swollen breasts, arms and fingers as well as face, weight loss, faint very easily, stomach pains, swollen lymph nodes and glands, depression, anxiety. I started to feel better after that surgery. I got breast implants in (b)(6) 2011 within weeks i began feeling aches, pains, fevers, chills, racing heart, hair falling out. Link. My husband began to research that possible relationship. Posting Date. Knee/joint pain. Please help me before i lose my life. Mentor Textured Silicone Implants. Fatigue pressure on face (under eyes, around nose) constant headaches, tingling in hands and feet (fall asleep, drop things, difficulty opening things, typing etc). This event was reported via # medwatch (mw5032276). Link. Something needs to happen you have dropped the ball on this. Lowered immune system, and i get sick (strep throat, colds) and i never used to, slow clearing of colds. I know many women do whether they have had autoimmune illness before or not! (Unknown if it is Mentor saline or silicone). 7. Contact the relevant medical authorities who conducted the surgery and request an updated Mentor breast implant recall information. 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). Recalling Firm. Additional complications are also covered for 10 years with free product replacement. 350-2350 I was fine for the first two years. hbbd```b``@$Sdu`3f3e"o$?Y0Y9fH(9 DINc }@`Fg` !P Mri confirmed that the breast implant had ruptured. However, no further information has been made available. /f&b2jy|/ZS [=s I have mentor breast implants that were placed in (b)(6)2007. However, i am left with a chronic illness now that most likely will need some medication, supplement, and labs and doctor visits to manage for the rest of my life. Device description with a list of specific materials in the device. Tested positive ana for possible lupus. In 2014 i started to get swelling in my fingers and toes. Do your research ladies, get a $$ loan if you have to, your health is worth it! (b)(6) of this year started a severe decline in my health. Link. Within a year, i began to experience headaches, fatigue, chronic joint pain in left side of neck, shoulder, hip, knee, brain fog. Muffled ears like swimmers ear. Link. Link. Unexplained rashes, difficulty walking and breathing, pain in my joints, couldnt touch my body. Pain is intense, particularly in the mornings or after sitting for a while. My diet is impeccable, the products i use on my body are as clean as it gets- completely 100% organic, all natural, no preservatives, etc. it was a walk in the park! Site of lymphoma: right side. It is also possible that you will not recoup the associated costs until after you have paid for the procedures and check-ups in advance. 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). Over the next 3 years my health steadily declined with unexplained symptoms. I am ashamed of the mentor company because of the old and new medical research the proves these implants ar highly toxic. Link. Link. (Unknown if it is Mentor saline or silicone). Only need to get an mri if you suspect a rupture or feel contracture. Weekly b12 injections. However, no further information has been made available.