Shame on the implant companies, shame on the FDA and shame on doctors who dont give you enough information!!!!!! Here are my symptoms: hormones are imbalanced (out of wack), hypothyroid. Had breast implants put in and have had failing health since. MENTOR Breast Tissue Expanders. I also have become intolerant to smells and chemicals. 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 was diagnosed with alcl in 2016. I was a very healthy, active person up until all of this happened. MENTOR - Contact Us PATIENT INQUIRIES AND WARRANTY INFORMATION If you are a patient, please contact us using the resources below for additional information about breast augmentation, breast reconstruction and breast implants. The changes i have had in my body in the past 15 months have been so drastic for me. I have mentor breast implants that were placed in (b)(6)2007. Developed anxiety and uncontrolled vaso-vagal responses. My doctor said there is nothing that can be done to prevent or fix the deformity once the implants are removed. Rushed to surgery for third time. Tested positive ana for possible lupus. I got mentor implants. Metalic taste in my mouth. Manufacturer Address Mentor Texas, LP., 3025 Skyway Cir N, Irving TX 75038-3524 Manufacturer Parent Company (2017) Johnson & Johnson Source USFDA I have a lot of health issues because of them. Besides developing multiple food sensitivities, i have also developed an extreme sensitivity to mold and chemical exposure. But since the surgery i feel like my lymph nodes are constantly swollen and keep struggling to fight off infections and colds. In 2013, American Society of Plastic Surgeons (ASPS) commissioned a systematic literature review to be conducted by Tufts Center for Clinical Evidence Synthesis, funded by three breast implant sponsors, and the advisory board approved the final report on 8/1/2014. 2. I immediately felt relief in my joints and muscles as soon as they were removed. I am hoping i will get better after explanting. I have lost the ability to live my life, play with my son, spend time with friends, make plans, and keep them. I do not know the exact dates off hand. 14. 10. I was healthy and active prior to breast implants. I have chronic widespread pain and digestive trouble. One weekend in early 2014, i took a severe turn for the worse. After (b)(6) of lab work, my dad mentioned seeing a news broadcast about toxic breast implants. Finally, i developed a goiter and a high cortisol level. I lost six years of my life to the implants and now am being told i have to have a hysterectomy from the endometriosis that was brought on by the increased periods that were triggered from the endocrine disruption from the implants. Mentor silicone implants caused a slew of health issues. Night sweats. Esophagus is where it is stuck, it takes hours to get these disgusting chunks out of my throat and its exhausting. 350-1610 Manufacturer requested implant and packaging directly from or team to investigate. 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 had developed severe food allergies and a few other symptoms about a year prior to the rupture, but thought nothing of it. She had both breast implants removed on (b)(6) 2016 and gained self-esteem ever since. Other diagnosis are for fibromyalgia due to the chronic pain i suffer. No further information is known regarding the patients medical history, status, hospitalizations, medical or surgical interventions that were performed. I was diagnosed with hashimotos thyroiditis 3 years ago. I have followed every recommendation that has been made in regards to the breast augmentation surgery. Severe food, drink and chemical sensitivity. The product was a silicone gel breast implant. I thank the rheumatologist for validating the fact that the implant could be the cause. I am convinced that all of my problems stemmed from the holes in them. Epidurals and physical therapy for years. Sit back and relax while we do the work. My body couldnt sweat couldnt get rid of toxins. Anaphylactic symptoms. 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. I was given iv cipro for several days. Some respondents suggestedthat the true purpose of the brochure was to protect Mentor, rather than inform patients about breast implant surgery. 6. Multiple attempts have been made to obtain more event details, however, no additional information has been made available. 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. 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. No further information was available. MENTOR MemoryGel Breast Implants and MENTOR MemoryGel Xtra Breast Implants are round devices with shells constructed from medical grade silicone elastomer. 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. 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. 350-2375 I struggle everyday to do things and plan to explant soon. The procedure was completed with different device. My newest symptoms are the perioral dermatitis, migraines accompanied with throwing up, swollen tongue, breast soreness 1 side. Due to having a birth defect i got mentor gel silicone breast implants in 2008. Five years of being sick. Dry eyes, blurred vision, double vision, and eye pressure. Smooth surfaced implants are not affected by. (Unknown if it is Mentor saline or silicone). I have had recurrent bacterial vaginosis, utis, black-ish green discharge form breast nipples (tested and came back as staph infection). 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. This final guidance contains recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants. It was reported that a (b)(6) year-old female underwent primary augmentation surgery using mentor silicone implants. I was able to return to a mostly normal life, although the symptoms never went away. I noticed it has a Ribble in it, and it has a bubble, the bubble caves in when touched. 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. Link. After approximately 1. Note: If you need help accessing information in different file formats, see **1 y* I got severe spinning vertigo that lasted 6 years. Bilateral breast pain from breast implants. During a bilateral breast augmentation, the implant that was to be used for the right breast was discovered to have/contain foreign material. 2 Mentor textured silicone gel implants. Due to length of initial surgery as well as length of hospitalization, i chose to wait. The patient believes that the discoloration is a fungus growth inside the right device. However, no further information has been made available. By this time, too, i began feeling malaise, and i then was weakened to the point of being unable to walk unaided. I was convinced that the implants had ruptured even though it didnt show up. Link. Constant fatigue, nausea, weight loss and ibs. What is your recommendation? On (b)(6) 2009 is the date i had surgery to have implants. Irving TX 75038-3524. 2 Link. Started feeling ill within a year, by year 3 i was so sick my labs pointed to lupus or sjogrens. 2 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. Link. 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 got so sick so fast and did not know why. Per the customer, the plastic wrapping the implant boxes was also damaged. Over the past 3 years i have slowly begun to improve. Multiple symptoms continue. There should be some kind of warning about the dangers of breast implants. Over the past 3-4 years, the intensity of issues has become severe. It was reported that packaging for implant sm mpp gel 400cc (p/n: 3504001bc; l/n: 7402435-060) had hole in it. They continue to get worse. 3 Unable to walk. Link. 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. From the middle of (b)(6)(the date my plastic surgeon explanted the implant), i became so debilitated that i could no longer walk. 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. 800-235-5731. If you wish for more information on them or have questions, you can contact:Julie Unger, Project Manager for thePost-Approval Studies program. 304 0 obj <> endobj A small number of implants may have a potential weakened shell on the patch area which may result in premature deflation. 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. Both of the implants had holes. Link. Focus Group Study: This study used 35 women to evaluate how patients understood the safety and labeling brochures. 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. I will be having my silicone implants removed. (Unknown if it is Mentor saline or silicone). For Additional Information Contact. In the past few years i have been suffering from extreme pain in my right breast. Link. She was scheduled to remove implants the following month. I have developed severe symptoms over the past two years to include: worsening peripheral neuropathy, muscle/joint/bone pain, and weakness, tremors, dizziness/blackouts, seizures, severe fatigue, mental confusion/forgetfulness, difficulty speaking, went into acute liver failure twice, weakened immune system/recurrent infections, rashes, wounds that wont heal, mood changes, heart palpitations, etc. Mentor reports this event with an abundance of caution. I have called the surgeon that performed the surgery to get in for check up. I have multiple autoimmune issues ,thyroid issues and pain all of which only became present after silicone breast implants. If I had been told that any of these possibilties, I never would have had them put in!!!!! Before sharing sensitive information, make sure you're on a federal government site. Date of explant is scheduled for (b)(6) 2017. By (b)(6) 2016, i began experiencing tingling and numbness in my fingers, which was not going away. Link. 2*3*2*=JOSTx*=JOMtK7,&a0{\bL+iw]'k endstream endobj startxref Some days cant get out of bed. I come from a long line of healthy people who mostly live into their nineties. I have pictures, notes and many bills. It was reported that the patient has suffered bodily injury and resulting pain and suffering, disability, mental anguish, loss of capacity for the enjoyment of life, hospitalization, medical and nursing care and treatment, loss of ability to earn money in the future. Panic attacks, chest pain, breast pain, inflammation, depression. 350-3380 Now i am homeless. 350-1635 It is related to my breast implants in my opinion. Arthritis in my hands, swollen feeling, vision issues, hypothyroid, hashimoto, crepe like/dry skin. Avoid delays that will only cause undue stress, worry, or possibly affect your health by using DoNotPay. The swelling comes and goes. I had silicone breast implant and for years had every test there is to find out what was wrong with me. The implanting surgeon ran a suture through the implant when placing them, they began leaking soon after placement. Link. UT]b$c} I did not smoke, do not use drugs, do not consume alcohol and eat very clean. Very weak, couldnt walk a flight of stairs. I am getting sicker and sicker. Abnormal blood test results since 2012. Manufacturer Mentor Texas, LP. 350-3290 Link. DoNotPay can assist you with a simple, easy-to-use process in one place. dizziness (light headedness). The implants are scheduled to be removed on (b)(6). Since I had them implanted my body has changed tremendously from brain fog, GI issues with severe bloating. Will only cause undue stress, worry, or possibly affect your health using. 1 side ran a suture through the implant could be the cause fight off infections and colds,... 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