I had mris to check for issues with neck- diagnosed at first as herniated discs but then as arthritis. Posting Date. Stomach issues: burning in lower abdomen, reflux heart races, chest pains, (stabbing pain , both sides). Link. Important information: i have been very diligent in following doctors protocols and have preferred diet and exercise over medication if at all possible. It has been a year of feeling acutely ill. Then in 2011, i was diagnosed with a rare blood cancer. Rheumatologist said i am at high risk for lymphoma. I am ASAP to get my life back! it was a walk in the park! This is five years of my life i cant get back. Since explanting, i already am noticing symptoms subsiding such as my brain fog, temperature regulation and ability to focus clearly. Only need to get an mri if you suspect a rupture or feel contracture. Muscle pains and joints. I have good days and bad days and my life has forever been impacted after having these poison bags put in my body. =h48(!_)L K=%.R0-&S t88/ DoNotPay will send your implant recall request to the manufacturing company on your behalf, asking for a refund or replacement. Shame on the implant companies, shame on the FDA and shame on doctors who dont give you enough information!!!!!! The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates. From that time on, i developed more and more symptoms that piled on top of each other. Abnormal blood test results since 2012. endstream endobj 308 0 obj <>stream In the event of an unexpected qualifying deflation of a MENTOR Saline-filled Breast Implant, Mentor will replace the product, free of charge, for the lifetime of the patient. Link. Diagnosed with mid foot osteoarthritis and surgery was suggested. I could not raise my arms, move my legs or use my hands. 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. Mentors failure to address these concerns and comply with its post-approval study requirements is a violation of the firms pre-market approval order., FDAs warning letter to Mentor Worldwide LLC (Mentor). I did not get well after the surgery, although he was able to take out 130 ccs of material on one side and 210 ccs on the other. * In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. To be able to walk and have energy again, and hopefully for the arthritis symptoms to diminish. Panic attacks, chest pain, breast pain, inflammation, depression. I have breast implants and they are causing chronic inflammation in my body leading to various health conditions even to hospitalization. Hair was falling out, constantly getting sick with sinus issues cold, cough, infections, strep, sore throat, brain fog, tired, low libido. 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? Link. It was reported via mw 5065152 that a female patient underwent a bilateral breast augmentation surgery in (b)(6) of 2013. Within 6 months of that time frame, i started to have medical concerns, which were unusual for me. I started having sensitivity to foods which i never had before and the foods cause pvcs. The product was a silicone gel breast implant. The hospital has denied the mammogram caused the rupture but both at the same time is so obvious. Contact the relevant medical authorities who conducted the surgery and request an updated Mentor breast implant recall information. Brain fog, anxiety, depression, numbness, sore, fatigue, loss of ability. Rushed to surgery for third time. These issues impact daily. The left was adhered to my ribs!!!!! Insomnia, feeling dizzy, or faint, almost blacking out (everything goes dark and i see stars). Her email is [emailprotected] and phone number is (301) 796-6134. Core Study:The follow-up rate was 62% at 10 years. 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. Frequent migraines with vomiting extreme fatigue hair loss blurred vision acting joints right arm-numbness and pain 20 pound weight gain and bloating of abd and frequent heartburn, brain fog with memory loss and difficulty focusing anxiety and flat affect cold intolerance esp hands and feet. Link. 350-1620 However i had in 2010 began to be diagnosed with many more autoimmune disorders. 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. 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 began using a cane, then a walker, and eventually had to be pushed in a wheelchair. UT]b$c} Started feeling ill within a year, by year 3 i was so sick my labs pointed to lupus or sjogrens. I still have most symptoms, but many have improved at least slightly. I was able to have a visiting nun come once a week also. I was convinced that the implants had ruptured even though it didnt show up. Difficulty sleeping. Within 3 months, my health took a sharp decline with life threatening arrhythmia issues which required cardiac ablation and meds. I have this implant, I had it 4/2017. Alcl stage and alcl treatment are unknown. I had reconstruction due to breast cancer with mentor memory gel silicone implants 300cc. /f&b2jy|/ZS [=s Breast tissue was not sent for histology at that time. Medical Device Recall of MENTOR Smooth Round Saline DV Breast Implants Page 1 of 6 Event #7209. Ongoing unexplained upper respiratory infections (went to sinus specialist and despite numerous tests she could not find cause), body rash, large itchy painful welts on my breasts, heart palpitations, anxiety and depression, joint pain, ringing in my ears, etc. Upload photographic evidence of your purchase and the product if you still have it. 3 During this procedure, the surgeon noted that the right breast was discolored (brown). Not every women is genetically the same and there are many that will not be able to tolerate the implants. Teague urinary incontinence, dry skin, sjogrens autoimmune, hair loss, burning around the breast tissue, two air forms of thyroid cancer, chronic fatigue. I have hot and cold sensitivities. Link. 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. My situation was as such: in (b)(6) 2015 after being diagnosed with ductal carcinoma in situ (dcis) for a third time in 12 years, i had a mastectomy with immediate reconstruction on my right side, with a mentor gel-filled implant. Link. Link. endstream endobj 311 0 obj <>stream SQ*ONlG7[Gqt9`)/kKJ`%KP\gmht(1IsNeX|J-J|beLYh7uq&%#y6i/UsBA{GxZB5-8nWW!A`y]4M6AbQb&'g*-i!czb@68CsbD6UHpVq hx/Mebx- s. 350-2200. 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. Link. I had follow-ups with my surgeon and everything seemed to be fine but the symptoms continue to become worse and more frequent. 3. It was reported that one female was implanted with mentor silicone breast implants in 2006. )7:Evvc},,dK9%"Ty.73&X6H(TQzz?n7?"=O[U? In (b)(6) 2016, the patient underwent surgery and the mentor memory gel implants were removed. This has been hard to read as I had Mentor gummy bear implants in 2017 after breast cancer surgery. At the time year mark of getting implants, after being diagnosed with all of these issues, i saw multiple doctors and kept telling them i have a concern it was my implants making me sick. My body couldnt sweat couldnt get rid of toxins. 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. 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. Difficulty swallowing/fullness in throat, decreased libido, low energy, exhausted, weak, memory loss, difficulty concentrating and brain fog. How the Product Recall Claims product works: And that's it! 5 years ago. (Unknown if it is Mentor saline or silicone). This impact is widespread and debilitating. I developed raynauds syndrome, and symptoms that look like rheumatoid arthritis, but a rheumatologist tested my blood and it was negative for this condition. I would say to anyone thinking about breast implants DONT!!! During the last few years, ive had a swollen lymph gland underneath my right arm that repeatedly i was told was benign and nothing to worry about. Link. 1. What is your recommendation? In 1998, i had a reconstructive surgery and mentor brand, textured, silicone implants were implanted. 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. 7. I finally had them removed today. Link. Updated silicone gel-filled breast implant rupture screening recommendations. Avoid delays that will only cause undue stress, worry, or possibly affect your health by using DoNotPay. I went to the er, where they werent sure what was wrong and gave me antibiotics, which had no effect. Ive been reading endless stories online. Patient had implants explanted on (b)(6) 2016. I dont even know how to put it in words. endstream endobj 312 0 obj <>stream 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. Updated labeling to communicate long-term study results is pending for all implants in this table. MemoryShape PostApproval Cohort Study (formerly Contour Profile Gel Core Study) Final Clinical Study Report . When recalls are as vital as a Mentor breast implant serial number recall, you should never ignore them. I had these mentor silicone implants placed in 2007. Implant provides the natural feel patients desire with increased form stability to shape the breast. Worsened over a period of 5-7 years post implant. The patient had the implants surgically removed on (b)(6) 2017, at which time the surgeon noted that the implants were leaking. As time continues to pass, more symptoms seem to be showing up. I got breast implants in (b)(6) 2011 within weeks i began feeling aches, pains, fevers, chills, racing heart, hair falling out. Since I had them implanted my body has changed tremendously from brain fog, GI issues with severe bloating. 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. Additional xrays and a great deal of blood work to determine arthritis issues which seem to be taking over my body (was diagnosed as rheumatoid arthritis, but medications have not helped reduce the issues it causes. I was implanted with mentor memory gel silicone breast implants. Mastitis, cellulitis of the breast. Besides developing multiple food sensitivities, i have also developed an extreme sensitivity to mold and chemical exposure. hXmo7+br@/M`I8]pqa#yb;7`FERH=:Z+3)5Ii-2ZLyA Migraine headaches, depression, heart palpitations, nausea, and anxiety. Also. All symptoms started on the right side of my body, and were more severe than on the left side of my body. I grew increasingly weaker and more ill. I happened to notice that one of my breast implants (from breast cancer in 2000) had gone flat. Just came across the breast implant illness. Due to having a birth defect i got mentor gel silicone breast implants in 2008. However, in October 2021, Mentor initiated a voluntary recall of its smooth, round saline diaphragm valve breast implants . Link. I have gone through all my savings trying to get better! The surgeon seemed to do an adequate procedure of placing the implants back in (b)(6) 2014. Bad gastrointestinal and digestive issues, nausea, intense night sweats and hot flashes, poor sleep and insomnia, anxiety and depression. Symptoms: fatigue, endocrine issues, depression, panic attacks, insomnia, joint pain and cognitive dysfunction. There i saw my right implant was completely ruptured. I have had thyroid cancer, parathyroid tumors, thyroidectomy with parathyroidectomies, inability to work for over one year, fibromyalgia, asthma and copd the list goes on and on. I started in (b)(6) going to doctor. Went through chemo then had a stem cell transplant in (b)(6) 2016. 5. 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. Link. I had them taken out. Tingling hands and feet, cold hands and feet, tempt, intolerance, light sensitivity and noise sensitivity. (1/5/17). (Unknown if it is Mentor saline or silicone). Have mentor breast implants. Link. I thank the rheumatologist for validating the fact that the implant could be the cause. I still have severe ringing in my ear that hasnt left. Link. Patient suffered pain on the left side for the past year and it was getting worse. 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. Pathology and currently waiting to explant. It was reported that (b)(6) the female patient underwent primary breast augmentation surgery using mentor gel implants in 2000. 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. Finally, i developed a goiter and a high cortisol level. Initiating a recall claim for a Mentor implants recall can be a stressful process on top of what is already a stressful situation. Link. Link. 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. MENTOR MemoryGel Breast Implants and MENTOR MemoryGel Xtra Breast Implants are round devices with shells constructed from medical grade silicone elastomer. 3 Link. Along with that were 35 other symptoms. I was told these implants were inert and safe for implantation and that was clearly not the case for me. Extreme swelling throughout my body had to use a lymphatic drainage machine 2xs per day for 75 minutes. For our MENTOR Breast Implants, if a rupture occurs within 10 years of surgery, you will also be eligible for up to $3,500 in nancial assistance for surgical costs. Manufacturer requested implant and packaging directly from or team to investigate. 350-1640 Additional complications are also covered for 10 years with free product replacement. I am carefully monitoring my progress but something needs to be done about this as i am one of thousands upon thousands of women who have all had this same problem. I believe as i stated before they have exacerbated my autoimmune challenges. The sale and distribution of Mentor Breast Implant Devices are restricted to users and/or user facilities that provide information to patients about the risks and benefits of the device prior to its use in the form and . Since the removal of the implants, i have had 2 addl reconstruction surgeries including a latissimus flap. I have mentor cohesive gel breast implants and experienced symptoms almost immediately. Link. 1* Choose from a wide range of sizes and profiles including Moderate Classic, Moderate Plus, High, and Ultra High. My upper body muscles ache, and i continue to have difficulty sleeping. 350-2225. 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. Link. (Unknown if it is Mentor saline or silicone). She had both breast implants removed on (b)(6) 2016 and gained self-esteem ever since. I even developed (b)(6) 3 weeks after the surgery under my armpit, which ive never had. (Unknown if it is Mentor saline or silicone). 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. 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