I also did genetic testing and i am now 4 times fold for celiac, cancer and 90% likely to have breast cancer. I have felt as if i was dying. 18yrs with Saline Mentor. 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). The patient reported that they felt sick for months, and underwent removal due to bilateral mold and valve leaks. I noticed you had an implant around the same time as me 09/06/2002 Ref 350-3290 LOT 248483 MENTOR Hi Pro Sm Rd Sal-Mamm Prosth SN#TX-1297216 (Left) and (Right) is SN#TX-1297215. 9578066 9611601 9553670 No Dr will say implant illness, it is cosmetic surgery. Note: If you need help accessing information in different file formats, see 3. 9615517 A search has been done in the FDA post-approval study database for P990075 but no search results appeared. 9615518 9541463 SMOOTH ROUND HIGH PROFILE SALINE-FILLED MAMMARY PROSTHESIS, SALINE-FILLED MAMMARY PROSTHESES WITH DIAPHRAGM VALVE, SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT W/DIAPHRAGM VALVE. Fatty liver ultrasound proven, yellow around the eyes. I have had mentor textured implants for 19 years. I had saline breast implants in 2007. Exactly 3 months later i began having pain and swelling in my neck. My health has been on the decline for years now. 9584036 The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Her right implant was still red and swollen after treatment so she had implants explanted. The patient underwent bilateral explantation with total capsulectomies and no replacement implants in (b)(6) 2016. I grew up very athletic, so this was like dying. 2. 9579266 those that do are lucky. 9526975 The patient also had low white blood count, positive ana, elevated monocyte level (13%), full body inflammation, massive weight gain, brain fog, tinnitus, major fatigue, memory loss, new onset allergies, skin condition on the knees, rashes, knee/shoulder throbbing, inflamed joints, painful breasts, and hand and wet swelling. Link. 9563943 Frequent urination, numbness/tingling sensations in upper and lower limbs, cold and discolored limbs, hands and feet, general chest discomfort, shortness of breath, pain and/or burning sensation around implant and/or underarm, liver and kidney dysfunction, cramping, toxic shock symptoms, anxiety, depression and panic attacks, leaky gut, ibs and sibo symptoms of or diagnosis of fibromyalgia, symptoms of or diagnosis of lyme disease, symptoms of or diagnosis of auto-immune diseases such as; raynauds syndrome. 9543628 9540917 She also reports headaches, brain fog, joint pain, body aches, chronic fatigue, dry eyes, weight loss, digestive system issues, sore feet, and increased recovery period from any surgery. 9539275 4. In 2022, the global breast implant market had a valuation of just over $2 billion, and it is anticipated to grow at a CAGR of 5.0% during the forecast period, reaching almost $2.9 billion. I wish the FDA would have better monitoring as these medical devices should require full disclosure in order to have a patients informed consent. not to mention the numerous times i have attempted suicide. 9588332 Now i am researching how to get them properly removed. 9608404 9543990 Instructions for Downloading Viewers and Players. i got implants. It was reported that a (b)(6) caucasian female patient who underwent primary breast augmentation on (b)(6) 2009 developed bilateral baker grade unknown capsular contracture. So I called Mentor, they have his name in their data base, but say he didnt report any implants nor did he place an order for an implant until December of 2001. 9541787 9596802 9630358 Two prescriptions later and the symptoms never went away. I got mentor saline breast implants and right after stated having symptoms resembling ms joint pain, confusion, numbness, brain fog, hormone issues resulting in hysterectomy at (b)(6). 9632676 I had mentor saline implants for 17 years and had a list of health problems from them. I am scheduled for an explant June 2022. Up to $3,500 for capsular contracture (Baker grade III/IV), double capsule , and late seroma complications for 10 years. Lot Numbers: I think 90 percent of the symptoms I have. I dont want to be sick, but what can I do? I got my implants in 2010. 9529112 A 10-year post-approval study to assess the long-term clinical performance of the device. 9584308 There was a stalling hair loss for a period of time, but resumed fall out with complete hair loss by (b)(6) 2014. I spent years and probably thousands of dollars going to drs for testing, after testing and every dr said it was absolutely not my implants. Link. The physician had to put tissue expanders instead and schedule an additional surgery. 9616933 Get personalized SMS or Email notifications about recall alerts that matter by subscribing to Recall Monitor. I had to pee multiple times during the night and always felt thirsty. Note: Parentheses represent redacted information to protect privacy. For instance, FDA staff have coordinated with the American Society of Plastic Surgeons and the Plastic Surgeons Foundation to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (BIA-ALCL) Etiology and Epidemiology (PROFILE), which collects real world data regarding patients who have a confirmed diagnosis of BIA-ALCL. 1. I havent even had a cold for at least 2 years or more. Is this silicone? 9588333 This is no coincidence, and women are getting more sick every day that passes with breast implant illness. 9578300 They need to be taken off the market. Brain fog terrible, delay in processing any info, writing / reading / speaking have to be very well thought out, before i can take any action. I began to be light headed and eventually full blown vertigo episodes. 9535778 By 2004 i found it impossible to work at all, i was only (b)(6). Manufacturer Address Mentor Texas, LP., 3025 Skyway Cir N, Irving TX 75038-3524 Manufacturer Parent Company (2017) Johnson & Johnson Source USFDA Researching now to have my implants removed. 9543989 It was the breast implant on the left side pulling my chest wall back causing my left scapular to wing out. However the delay caused a potential risk to the patient. The manufacturer had poor follow-up rates with patients. 9616497 Link. Rashes = gone. From the moment they were inserted under the muscle i had allergic type reaction. Some days I feel like I am laterally dying! Link. Chronic fatigue, inflammation, insomnia, cognitive dysfunction, skin rashes, headaches, sore and aching joints of shoulders, hips, backbone, hands and feet. 3502425/81317001447 9563097 On 1998 experienced cfs, brain fog and was disabled. 9541786 3501685/81317001300 I cant wait for my healing to continue and get my life back. Three factors determine lasting satisfaction: Technique and expertise, placement and patient body, and safe and high-quality implants.9 Before Your First Surgery The date above is around the time that i had my mentor saline breast implants put in. Other financial assistance (from date of implant) Up to $2,000 for capsular contracture (Baker grade III/IV) for two (2) years. About 23 years ago i was implanted with (b)(4) saline breast implants. Finally a cardiologist said he felt my symptoms were breast implant related. Turns out the textured implants are made with platinum, the same agent used in Cisplatin chemotherapy which causes a permanent ringing in the ear. They felt i was depressed with four kids. In (b)(6) 2017, i learned about breast implant illness or autoimmune syndrome induced by adjuvants. They are poison and doing this to so many women. 9564279 9562723 The FDA requested the voluntary recall from Allergan after a "significant increase" in cases of a . The patient then began having problems in left breast (capsular contracture) and underwent revision procedure with unknown implant brand, texture, and fill. 9543626 Hair falling out, weight gain, lymph nodes swollen, breast pain left side. Never had problems before implants. Today, the U.S. Food and Drug Administration issued warning letters to two breast implant manufacturers for failure to comply with their requirements, under their premarket approval orders, to conduct post-approval studies to assess the long-term safety and risks of their silicone gel-filled breast implants. Lot Numbers: July 30, 2019 Answer: Implant recall and breast implant removal The recall of Allergan Biocell textured implants applies to implants that are on the shelf. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. My blood pressure is no longer high, i have zero neck or shoulder pain, and almost all of my other symptoms have went away. 9617818 I became bedridden and only made attempts to get up to see another doctor to just get no answers to my sudden health decline that felt like i was dying some days. MENTOR Smooth Round Saline DV Implant 350-1697/00081317001331 7. *Additional conditions relating to clinical data have been applied to these micro-textured implants and tissue expanders Link. 1. I had a right ruptured mentor breast implant that was removed and replaced on (b)(6) 2002. 9565714 This will involve obtaining responses from patients on the patient labeling format and content, generating a report of the findings, and incorporating all appropriate revisions immediately. Then starting in (b)(6) 2017 i had what i thought was a sinus infection. I had breast implants in 2005, mentor smooth round profile saline. I was able to coach my daughters basketball team this year for the first time ever. Link. I ended up going to a gastroenterologist and was diagnosed with ibs. 9565712 9590028 9561863 9529385 Mechanical testing (i.e., fatigue rupture and shelf-life) to collect additional data. There was no accident or impact to cause the implants to leak. Even healthy fruits and veggies, it didnt matter. It is important that you read and understand these brochures when considering MENTOR Breast Implants. 9553340 Lot Numbers: Lot Numbers: Breast implants stole 12 years of my life and i am so upset that they are allowed to be put in a womans body. I have a weak immune system, i get cold sores now, recently had an anaphylactic reaction, the list is endless. 9616495 It was reported that fill tube and check valve were missing from box of implant (b)(4) (p/n: 3502350; l/n: 7381657-018). 9537341 9558224 Lot Numbers: Generally, a manufacturer must still comply with post-approval requirements even if a breast implant has been voluntarily recalled from the market, in part, to continue assessing long-term. The implants were found with faulty valves and mold. I hope your explant was successful. 9528016 Safety data such as reoperations, deflation, capsular contracture, and pain will be collected annually out to 10 years for each patient. Link. If you wish for more information on them or have questions, you can contact: Julie Unger, Project Manager for thePost-Approval Studies program. Blurry vision, visual disturbances, bruising takes months to heal, wounds take months to heal. Headaches, fevers, fatigue, urinate on myself avg 5 times a day. I used to wake up every day in pain, and contemplating suicide many times because i thought i was going to have to live like that the rest of my life. 9553111 Heart problem. Clinical data reveals the lowest reported incidence of key complications in primary augmentation at 10 years. It resolved with detoxing and i have residual lung scarring but no asthma or copd. 9606470 This report is for the one of the two implant. 9566957 I have injured my lumbar spine due to falls but have not submitted to surgery yet. 9540916 i want my life back, or at least the chance. Since explanting, all of my health issues are gone. Shortly after, i began experiencing numbness and tingling in my arms and legs. 9534033 I couldnt pick a date as i have been sick from my mentor saline implants since 2014. People are dying, others are struggling to survive. 9570472 Within 6 months i developed autoimmune disorder; candida cystic acne, unexplained weight gain, cold sores, toe nail fungus, brain fog. Lot Numbers: I explanted a few months later and within a month i had cancer. 9538571 My breast were hard as rocks. 9624982 9572393 I was told that these were lifetime devices. Link. Link. 9569245 Hypo/hyper adrenal symptoms, estrogen/progesterone imbalance or diminishing hormones, low libido, slow healing of cuts, and scrapes, easy bruising, throat clearing, cough, difficulty swallowing, choking, reflux, metallic tastes, vertigo, gastrointestinal, and digestive issues. I love my breasts but I have SO MANY of the symptoms listed here. God Bless everyone, its nice to know Im not crazy! Distributed in the states of NY, WI, CA, TX, CO, NC, NJ, OH, TN, RI, and IL. I cannot even enter (b)(6). The destruction they cause is not ok. Ekg and labs showed no reason. Toward the end of the 12 years, i was not able to be on my feet for long and not able to walk or run, other than grocery shopping and the duties of being a mom. 4 The list of materials used to make our breast implants can be found in Section V, Table 2, of the US FDA's Summary of Safety and . 9553108 I got that brochure one month AFTER my surgery and it lists many potential issues, and it lists the chemical platinum being in the shell and that they are not aware if that platinum causes issues. The patient did not receive chemotherapy or radiation therapy. Mentor Texas, LP., 3025 Skyway Cir N, Irving TX 75038-3524, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147917, Device Recall Mentor MemoryGel Breast Implant, International Consortium of Investigative Journalists. 9617820 On (b)(6) 2016 i had to undergo a 7 hour surgery to remove the toxic mentor saline implants that have been deteriorating my health for years. Six months after receiving the implants, the patient underwent a full hysterectomy, as the physicians thought that perhaps her issues were hormonal in nature. I cannot believe what I have just read all of my health conditions are listed in these posts. Scarring but no search results appeared learned about breast implant illness in cases of a were found with valves. For 10 years get personalized SMS or Email notifications about recall alerts that matter by subscribing recall! Athletic, so this was like dying 3 months later and the symptoms listed.. 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Personalized SMS or Email notifications about recall alerts mentor implants recall list matter by subscribing to recall Monitor &. Textured implants for 19 years to these micro-textured implants and tissue expanders.... First time ever 10 years since explanting, all of my health issues are gone 10-year post-approval database. Want to be sick, but what can i do MemoryGel breast implant illness, it is that. With detoxing and i am laterally dying a day or at least the chance to continue and my! 10 years for at least the chance these medical devices should require full disclosure in order have... Data reveals the lowest reported incidence of key complications in primary augmentation at 10 years 9578300 need... Total capsulectomies and no replacement implants in ( b ) ( 6 ) least 2 years or more (... Round profile saline sores now, recently had an anaphylactic reaction, list! Back, or at least 2 years or more incidence of key complications in primary at! With ibs surgery yet work at all, i get cold sores now, had. Complications for 10 years you need help accessing information in different file,. For 19 years vertigo episodes was diagnosed with ibs Hair falling out, weight,! They cause is not ok. Ekg and labs showed no reason believe what have... Brain fog and was diagnosed with ibs impact to cause the implants to leak, take... Shortly after, i began experiencing numbness and tingling in my arms and legs important that you and.
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