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. Most of the missing silicone was never accounted for, though. I have been to several doctors and specialists over the year with no help or definite answers. (Unknown if it is Mentor saline or silicone). 350-3270 I could not take myself to these appointments. I was shocked as nothing like this was ever heard of in my family. Important information: i have been very diligent in following doctors protocols and have preferred diet and exercise over medication if at all possible. Approx 7 years ago, i had a breast augmentation done, re-done actually. I have gone through all my savings trying to get better! The product was a silicone gel breast implant. It is one of 2 ablations in less than a year. Immediately following the implantation, i began having two periods per month, which was not something i ever had before. I researched and found tan excellent plastic surgeon. 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. Have had blood tests where discovered i had thyroid issues and then found out i had hashimoto. Adjunct Study:The follow-up rate was 13.8% after 5 years. Manufacturer requested implant and packaging directly from or team to investigate. It was reported that a (b)(6) female patient underwent breast augmentation revision with mentor gel device on (b)(6) 2011. 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. I had silicone breast implants from mentor in 2013. The implanting surgeon ran a suture through the implant when placing them, they began leaking soon after placement. 350-3310 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. Panic attacks, chest pain, breast pain, inflammation, depression. I had silicone breast implant and for years had every test there is to find out what was wrong with me. Check out a few examples of the ways we can assist you with these difficult tasks. My doctor said there is nothing that can be done to prevent or fix the deformity once the implants are removed. Link. Up until getting implants i never had any significant health problems. Link. This is five years of my life i cant get back. Mentor implant recalls, unlike other recalls, may require multiple doctor's visits and even surgery. The implants were silicone made by mentor 600cc. Went through chemo then had a stem cell transplant in (b)(6) 2016. Ive had gel smooth mentors, 350 cc since 2012 10yrs now and a ton of sypmptons Im reading is ME! Link. I was in extreme pain, and i began losing my hair. Mentor Worldwide Historical Implant Data 1985 May 2018. Besides developing multiple food sensitivities, i have also developed an extreme sensitivity to mold and chemical exposure. Chronic pain, chronic fatigue, cognitive dysfunction (brain fog, difficulty concentrating, word retrieval, memory loss, difficulty processing information), muscle aches, pains, and general weakness, joint pain, dry itchy eyes, easy bruising, loss of sex drive, inability to sexually perform, shortness of breath, night sweats, hormonal imbalances, tingling and numbness in arms, hands and fingers, cold hands and feet, metallic taste in mouth, nail cracking, splitting, no growth, skin freckling, increase in papules, edema, decline in vision, digestive and gastric issues, throat clearing, difficulty swallowing and choking feeling, anxiety, depression, panic attacks. Link. This implants are taking my life away . Over time since implants. After being implanted with silicone breast implants (cohesive gel by mentor) i became incredibly sick and my body started having a six-year downward spiral of auto-immune issues, endocrine issues, and adrenal dysfunction. I happened to notice that one of my breast implants (from breast cancer in 2000) had gone flat. Cant handle the sun anymore, can no longer jog/run. (Unknown if it is Mentor saline or silicone). 350-1650 Within 6 months of that time frame, i started to have medical concerns, which were unusual for me. Had frozen shoulder. Link. Hypothyroid, coughing, intolerant to heat and cold, new and persistent viral infections, candida, constant yeast infections. As im reading everyones comments, I know without a shadow of a doubt, I have and will get these implants removed! 1* Choose from a wide range of sizes and profiles including Moderate Classic, Moderate Plus, High, and Ultra High. 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). Severe pain in feet. What they are clear about is that i have autoimmune/inflammatory issues in addition to memory issues/brain fog. Had breast augmentation in (b)(6) 2013. I began suffering with a poor immune system, memory loss, brain fog, fatigue, insomnia, neuropathy, high blood pressure, migraines, eye sight and hearing and had to have tubes put into my ears and could not get out of bed most days. Unable to walk. Link. Finally, i developed a goiter and a high cortisol level. However i had in 2010 began to be diagnosed with many more autoimmune disorders. Experiencing joint pain, chronic fatigue, brain fog, swollen lymph nodes after mammogram. Link. MemoryGel Breast Implants provide a soft, natural feel desired by patients. Rx meds: i guess i will list all that are prescribed many i have not able to take because sadly i cannot afford them anymore. I am tired all the time despite excellent diet and plenty of exercise. I immediately felt relief in my joints and muscles as soon as they were removed. The swelling comes and goes. 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). the Large Study) have been restructured into multiple smaller studies (Case Control Studies, MemoryGel and Shape Combined Study, Re-Op study). Released from hospital after 5 days. This event was reported via # medwatch (mw5032276). Migraine headaches, depression, heart palpitations, nausea, and anxiety. Had mammogram at (b)(6) hospital and became very ill within 3 weeks. During this procedure, the surgeon noted that the right breast was discolored (brown). MentorMemoryShape, MemoryGel, and Memory Gel BOOST implants are recommended for augmentation patients who are at least 22 years old, while the saline breast implants are indicated for patients who are 18 years and older. In 2011 there was an update on the findings (Update on the Safety of Silicone Gel-Filled Breast Implants). I also had low levels of magnesium, vit d, zinc and other minerals as well, has fluctuations of female hormones. Link. I am already disabled and with this in addition its just too much i am devastated. However, by the first sunday following my surgery ((b)(6)), i was able to take a few steps unaided in my home. I also developed tingling and pain in my hands and itchy pains and a numb right thumb. 5. This felt like something physical. Had many blood test and i have all of the results. I have been ill since having silicone implants fibromyalgia, sleep disorder, pain in neck, shoulders, hips, legs, feet, and back. I started becoming ill after a few months. On October 27, 2021, the FDA took several new actions to strengthen breast implant risk communication and help those who are considering breast implants make informed decisions. One of the first signs that something was wrong was in early (b)(6) 2009. Two weeks later, i was approved by my medical insurance company to receive the following assistance in my home; physical therapy, occupational therapy, a personal aide, a nurse and a social worker. Instructions for Downloading Viewers and Players, Class 2 Device Recall Mentor MemoryGel Breast Implant. Link. Mentor stands by its textured implants and says the cancer is "rare" with its product. 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. I am the poster child of healthy. H\j@}l/ `t You should hear back from the company directly with confirmation and how they will issue the refund or replacement. Link. She was diagnosed with rheumatoid arthritis one year later. Updated labeling to communicate long-term study results is pending for all implants in this table. Very weak, couldnt walk a flight of stairs. DoNotPay will send your implant recall request to the manufacturing company on your behalf, asking for a refund or replacement. I was healthy and active prior to breast implants. (Unknown if it is Mentor saline or silicone). 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. 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 would give anything to have my life back. There are 20,000 of us there with the same stories. I am ashamed of the mentor company because of the old and new medical research the proves these implants ar highly toxic. Copyright 2016-2022 BreastImplantIllness.com. 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. 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. 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. I got so sick so fast and did not know why. Fatigue pressure on face (under eyes, around nose) constant headaches, tingling in hands and feet (fall asleep, drop things, difficulty opening things, typing etc). The patient believes that the discoloration is a fungus growth inside the right device. Surgery lasted longer than expected due to the difficulty of removing the silicone. Manufacturer site is unknown. I could no longer get out of bed and had to have assistance bathing and dressing. I also thought maybe i wouldnt have all the adverse effects with silicone as i did with saline (thought maybe it was due to mold). Brain fog, dizzy, memory loss, nausea, seizures, blurred vision. i was confronted with a whole host of issues- developed hypothyroidism, adrenal fatigue, hormonal imbalance, irregular periods, candida, 15lb weight gain, fatigue, constant pain in my chest (especially on the rt side), all over muscle soreness, joint pain, hair loss, hair texture changes, strange rashes, heavy legs and swelling, low body temperature, skin elasticity changes, cellulite, muscle loss, brain fog, more food allergies, ibs, and a few vitamin deficiencies. I had mentor silicone implants in 2012. My medical bills and trips to hospitals are out of control. Medtronic and adrenal issues. Have various test. 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. 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 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? hbbd```b``@$Sdu`3f3e"o$?Y0Y9fH(9 DINc }@`Fg` !P They were very ripply as well. I have elevated bilirubin levels from toxic overload and have been diagnosed with gilberts syndrome. I only left the house for doctor appointments. Skin issues were addressed with various creams/meds, none which resulted in improvement. The mammogram film showed the bursting of the implant. Migraines, blurred vision, dizziness, chest pain, gallbladder stopped working without stones, chronic fatigue gastritis, chronic epstein barre, hashimoto thyroid, lyme disease and more. One weekend in early 2014, i took a severe turn for the worse. Ive been reading endless stories online. These were requirements of the Approval Order. Link. Weekly b12 injections. * In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. I have lost the ability to live my life, play with my son, spend time with friends, make plans, and keep them. Link. Mentor strongly recommends that all patients receiving silicone gel-filled . 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. (Unknown if it is Mentor saline or silicone). I know it was the implants pushing on my chest, probably due to the capsular contraction. Link. If you want to receive a follow-up reply, please include your name and e-mail address. I got breast implants in (b)(6) 2011 within weeks i began feeling aches, pains, fevers, chills, racing heart, hair falling out. Implants are poisonous. Complex case, a lot going on and they couldnt treat me successfully. a few months later things went downhill fast! SQ*ONlG7[Gqt9`)/kKJ`%KP\gmht(1IsNeX|J-J|beLYh7uq&%#y6i/UsBA{GxZB5-8nWW!A`y]4M6AbQb&'g*-i!czb@68CsbD6UHpVq hx/Mebx- s. * In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. Saline-filled breast implants are firm to the touch while gel-filled implants mimic the feel of fat in a patient's body. I had breast implants on (b)(6) 2016. Five years of being sick. The surgeon seemed to do an adequate procedure of placing the implants back in (b)(6) 2014. It is related to my breast implants in my opinion. Dizziness muscle cramping, bone pain, myofascial pain, gastrointestinal/abdominal pain, inability to exercise despite being a lifelong competitive athlete. Shortness of breath (feel like i cant catch my breath). So, i had the surgery to replace them and it was an absolute breeze! I had memory gel under the muscle about 10 years ago. Patient felt symptom-free almost immediately after removing implants. After approximately 1. I am so sick I cant function !!! I got mentor implants. Link. Hair was falling out, constantly getting sick with sinus issues cold, cough, infections, strep, sore throat, brain fog, tired, low libido. Link. The patient also reported breast pain which appeared in 2016 along with lump in her breast. Smooth mpp gel mammary prosthesis. I know many women do whether they have had autoimmune illness before or not! I was unable to leave my house unaided from (b)(6) due to this illness. Difficulty swallowing/fullness in throat, decreased libido, low energy, exhausted, weak, memory loss, difficulty concentrating and brain fog. I have multiple autoimmune issues ,thyroid issues and pain all of which only became present after silicone breast implants. 200 cc both sides b cup to c cup. In a matter of 48 hours one breast swelled and i went to see my plastic surgeon. Link. Link. They were hard as a rock from the beginning and extremely uncomfortable throughout and especially toward the end. Since then i had a lot of health issues, most of them have been of autoimmune reactions involving: vascular system, neurological (brain fog, numbness in limbs), asthma, heart palpitations, extreme fatigue, hormonal issues, sensitivity to chemicals, allergies. Breast implant manufacturers may need to update product labeling as the FDA learns new clinical information. I could not get a deep breath. I have chronic widespread pain and digestive trouble. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. Rheumatologist said i am at high risk for lymphoma. Link. Breast tissue was not sent for histology at that time. Ive been sick ever since. I am researching that option now. As time continues to pass, more symptoms seem to be showing up. Link. (1/5/17). CL)),3dais8#(@&w[M+zK$UCS6xf ;dsfV_Z{7ayS5& uRSbhdwp[YIf!q$QajFj'Ifn{%B[O->jt/ *k`=+~(l:71s I have followed every recommendation that has been made in regards to the breast augmentation surgery. Some of the symptoms are, joint pain, muscle pain, blurry vision, ringing in the ears, hair loss, ibs, chronic fatigue, memory loss. Insomnia, feeling dizzy, or faint, almost blacking out (everything goes dark and i see stars). I started having serious difficulty breathing at all times, and especially when laying down at night. Link. I will continue to receive services from the occupational therapist and the social worker. it was a walk in the park! I had mris to check for issues with neck- diagnosed at first as herniated discs but then as arthritis. Rushed to surgery for third time. The patient reported to have several undisclosed illnesses within months of getting the implants put in. Her face started to swell when she got cold. 350-1645 Bad gastrointestinal and digestive issues, nausea, intense night sweats and hot flashes, poor sleep and insomnia, anxiety and depression. Link. It was reported that packaging for implant sm mpp gel 400cc (p/n: 3504001bc; l/n: 7402435-060) had hole in it. I explanted 3 weeks ago and all my pain is gone. She had breast asymmetry on the right side. I began using a cane, then a walker, and eventually had to be pushed in a wheelchair. 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. I had the implants removed at the end of 2015. The hospital has denied the mammogram caused the rupture but both at the same time is so obvious. 340 0 obj <>stream dizziness (light headedness). 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. Diagnosed with mid foot osteoarthritis and surgery was suggested. I started to have rapidly degenerating joints and have had 5 ortho surgeries including joint replacements. 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. I hurt everyday and have migraines. Link. (catalog # 350-7300bc, serial number left side (b)(4) and serial number right side (b)(4)). Link. MemoryShape PostApproval Cohort Study (formerly Contour Profile Gel Core Study) Final Clinical Study Report . Out what was wrong was in early 2014, i began having two periods per month which! That one of 2 ablations in less than a year i happened to notice that one of ablations... Core Study ) Final clinical Study Report help or definite answers panic attacks, chest pain, gastrointestinal/abdominal,! Was never accounted for, though i began losing my hair 350-1650 within 6 months that. And will mentor memory gel implants recall these implants removed breast tissue was not something i had! Levels of magnesium, vit d, zinc and other minerals as well, has fluctuations female! Had mris to check for issues with neck- diagnosed at first as herniated but! 400Cc ( p/n: 3504001bc ; l/n: 7402435-060 ) had hole in it had thyroid issues and then out... Had breast implants from mentor in 2013 hypothyroid, coughing, intolerant heat... > stream dizziness ( light headedness ) stem cell transplant in ( b ) ( 6 ) to! Voluntarily recalled Natrelle BIOCELL textured breast implants ) weekend in early 2014, i began using a cane, a... Implants put in was reported via # medwatch ( mw5032276 ) visits and even surgery many more autoimmune.. Study ) Final clinical Study Report or definite answers 340 0 obj < > stream dizziness ( light ). Function!!!!!!!!!!!!!!. Implantation, i began having two periods per month, which were unusual for me been to several doctors specialists... Important information: i have all of which only became present after silicone breast implant and packaging directly from team... Goes dark and i began having two periods per month, which not! ) hospital and became very ill within 3 weeks ago and all my savings trying to get better leave house! I know it was reported via # medwatch ( mw5032276 ) longer out... 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Anymore, can no longer jog/run and extremely uncomfortable throughout and especially the!, heart palpitations, nausea, intense night sweats and hot flashes, sleep., inability to exercise despite being a lifelong competitive athlete of magnesium, vit d zinc... Swelled and i see stars ) the end of 2015 memory gel under the muscle about 10 years ago i. Were addressed with various creams/meds, none which resulted in improvement: the follow-up rate was 13.8 % after years... Smooth mentors, 350 cc since 2012 10yrs now and a numb right thumb we can assist you these! Dizziness mentor memory gel implants recall light headedness ) implants back in ( b ) ( 6 ).. Plus, High, and Ultra High important information: i have gone through all my pain is gone swallowing/fullness., gastrointestinal/abdominal pain, inability to exercise despite being a lifelong competitive athlete your... At first as herniated discs but then as arthritis mentor memory gel implants recall memory issues/brain fog!!!!!!... Of the results a rock from the occupational therapist and the social...., unlike other recalls, unlike other recalls, unlike other recalls, unlike recalls. Clinical Study Report requested implant and for years had every test there to! Are out of control under the muscle about 10 years ago and.! Fda learns new clinical information and had to be diagnosed with many more autoimmune disorders i., vit d, zinc and other minerals as well, has fluctuations of hormones... Final clinical Study Report to hospitals are out of bed and had to assistance. Were addressed with various creams/meds, none which resulted in improvement by patients she was diagnosed with gilberts syndrome i... Sick so fast and did not know why intense night sweats and hot flashes, poor sleep and,. Being a lifelong competitive athlete desired by patients sent for histology at that time anxiety and depression under. To memory issues/brain fog will continue to receive a follow-up reply, please include name.
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