Immediately, my breathing was cured! 350-3270 Told me to go to (b)(46 clinic. CL)),3dais8#(@&w[M+zK$UCS6xf ;dsfV_Z{7ayS5&
uRSbhdwp[YIf!q$QajFj'Ifn{%B[O->jt/ *k`=+~(l:71s Patient felt symptom-free almost immediately after removing implants. Once left breast was opened, implant was ruptured and silicone had settled into the fascia going completely underneath my arm pit and almost to my back. I dont even know how to put it in words. The patient had a mammogram done on 10/20/2015 that showed some micro calcifications in the left superior breast and recommended patient attempt to obtain prior mammogram images for comparison and for additional imaging (spot magnification views) to evaluate the micro calcifications. Cause 2. Immediately after removing the implants began seeing a new dr for help with this who after further lab studies diagnosed me with hashimotos thyroiditis which is an autoimmune disease more than likely caused by the endocrine disruptive toxins in the implants. Abnormal blood test results since 2012. This question is for testing whether or not you are a human visitor and to prevent automated spam submissions. 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. 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. 350-3380 I have 35 symptoms of Breast Implant Illness. There is no specific information regarding any diagnoses or symptoms. The hospital has denied the mammogram caused the rupture but both at the same time is so obvious. 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. Insomnia, feeling dizzy, or faint, almost blacking out (everything goes dark and i see stars). 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. 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. My personal aide and the nurse have stopped coming now as i am finally showing signs of recovery. However, no further information has been made available. Irvine, Calif., (January 13, 2021) - Mentor Worldwide LLC, the number one global brand in breast aesthetics, and part of . 350-1630 The nipples were 99% erect and felt swollen for most of the time. Focus Group Study: This study used 35 women to evaluate how patients understood the safety and labeling brochures. Patient was scheduled to have mri exam later. 11. A plastic surgeon implanted me with mentor memory gel silicone breast implants. I can walk short distances with the use of a cane; i still have to use an electric scooter or be pushed in a wheelchair if i have to stand for long or go very far. I am ASAP to get my life back! During a bilateral breast augmentation, the implant that was to be used for the right breast was discovered to have/contain foreign material. 350-2200. I have followed every recommendation that has been made in regards to the breast augmentation surgery. After approximately 1. Link. Medical Device Recall of MENTOR Smooth Round Saline DV Breast Implants Page 1 of 6 Event #7209. In July 2019, Allergan was forced to issue a worldwide breast implant recall for its entire line of "Biocell" textured breast implants. 5. I had upper back and neck weakness. 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. Multiple attempts have been made to obtain more event details, however, no additional information has been made available. Link. MemoryGel Breast Implants (Mentor Worldwide LLC, Irvine, Calif.), approved by the U.S. Food and Drug Administration in 2006 for breast augmentation in women aged 22 years and older and for breast reconstruction in women of any age, consist of a single-lumen, round silicone elastomer shell, with a patch on the posterior side, and filled with a cohesive silicone gel. I am convinced that all of my problems stemmed from the holes in them. Just came across the breast implant illness. I was acutely ill for several months, until the physician who had ordered the mammogram phoned me that something was peculiar on the mammogram film. There i saw my right implant was completely ruptured. Was sent to podiatrist and rheumatologist. It is one of 2 ablations in less than a year. Link. I have been sick for 5 yrs out of the 6 yrs I have had them and getting worse with time. 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. I did not smoke, do not use drugs, do not consume alcohol and eat very clean. Upon further inspection of the inner shell, the surgeon noticed black specs floating in the fluid. No further information was available. In a matter of 48 hours one breast swelled and i went to see my plastic surgeon. I would not recommend implants to anyone. There should be some kind of warning about the dangers of breast implants. I started to feel better after that surgery. With the help of DoNotPay, we can ensure that your breast implant recall claims are documented and filed to the fullest extent possible, so you can focus on taking care of your health. Each implant is filled with the Mentor proprietary cohesive gel that holds together uniformly and retains a natural give that better resembles breast tissue. Ive been sick ever since. My first symptoms in early 2000 with migraines. When i told the rheumatologist on (b)(6), that i had an implant and that i had made an appointment to see my plastic surgeon the very next day she said, you are right to mention this to me. The patient reported to have several undisclosed illnesses within months of getting the implants put in. I was able to have a visiting nun come once a week also. The alarming conflict of interest in the manufacturers sponsoring the studies and in the plastic surgeons handling the study is astounding. Implants robbed me of a year of my life!. I have heart issues, fatigue, high metal to city that can lead to significant cardiac issues. I had breast implants on (b)(6) 2016. 5 years, she began to suffer from serious health issues, including but not limited to, constant headaches, difficulty with concentration and focusing, constant pain and swelling in left breast, high anxiety, shoulder and neck pain, obsessive compulsive disorder, muscle weakness, symptoms that resembled fibromyalgia, insomnia, memory issues and other symptoms resembling chronic fatigue syndrome. Link. Wound is not healing properly. Mentor stands by its textured implants and says the cancer is "rare" with its product. Two doctors felt there was no rupture!!!! Second, the FDA approved new labeling for all legally marketed breast implants that includes: The breast implant manufacturers have posted the updated device labeling to their websites. Sometimes cant even have a bra touch it. Complex case, a lot going on and they couldnt treat me successfully. Pain persisted for months but eased in time. I want them removed as soon as possible because i know they are toxic and my body is reacting to them. As of today, (b)(6) 2017, im taking cipro 500 mg twice daily, drain is still intact, takes me over 2 hours to bathe, dry my hair and dress, because im fatigued. The rheumatologist took blood tests and results showed i had an autoimmune disease known as scleroderma. When recalls are as vital as a Mentor breast implant serial number recall, you should never ignore them. Avoid delays that will only cause undue stress, worry, or possibly affect your health by using DoNotPay. One of the first signs that something was wrong was in early (b)(6) 2009. Another said i was an interesting case as tests for memory mostly showed fairly bad short term memory. More research needs to be done and patients need to be warned of other medical harm that can happen because of the silicone implants. The surgeon seemed to do an adequate procedure of placing the implants back in (b)(6) 2014. Immediately following the implantation, i began having two periods per month, which was not something i ever had before. 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. I am researching that option now. It took me that long to convince my doctor that something was wrong!!!! 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). The symptoms are all still there and the issues persist despite medication and extreme lifestyle and diet overhaul. An e. N. T. Dr i went to questioned me about my implants and suggested, i think about having them removed. Toxic shock symptoms, corrective tissue disease, vision issues, headaches, nose bleeds, recurring pneumonia. The recall came after the FDA released data in 2019. Bia alcl swelling around implant need aspiration. The changes i have had in my body in the past 15 months have been so drastic for me. This final guidance contains recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants. 1 MENTOR Breast Implants are backed aJXtf"N2{7c1[>>Cl|4^LTA-L[fd-"e1[1X8x4F7m$98/lU ? I had severe discomfort, pain and burning for over a year!!!! 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. Trying to get original doctor surgeon to release my medical records. Spent a lot of money only to learn my implants made me sick i was diagnosed with fibromyalgia and hashimotos along with just guesses of what could be wrong. Even though i was under a trial study, mentor never contacted me and i dont think the surgeon reported as per the agreement i signed. 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. I was extremely healthy at time of the implant surgery and was told these were fda approved and very safe. I was able to return to a mostly normal life, although the symptoms never went away. Several years after my mentor smooth silicone implants were placed in, i noticed symptoms. MENTOR MemoryGel Breast Implants, MENTOR MemoryShape Breast Implants, and MENTOR Saline-filled Breast Implants are indicated for breast augmentation in women (at least 22 years old for MemoryGel Implants and MemoryShape Implants, and 18 years old for Saline Implants) or for breast reconstruction. You should hear back from the company directly with confirmation and how they will issue the refund or replacement. UkEq5LuEBf&ei'FKNl, @HfoB}S#L
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Difficulty sleeping. FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements (3/19/19). Often, people will ignore or pass up opportunities for compensation for these faulty products. 350-3290 325 0 obj
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I have been ill since having silicone implants fibromyalgia, sleep disorder, pain in neck, shoulders, hips, legs, feet, and back. I come from a long line of healthy people who mostly live into their nineties. Now i rarely leave my house never without assistance. hb```l@(0>.JO;%.mP'cGGE[GCKGGG>aS4FeX#aD{9L'0baZ\C@Ib @w?Vf . However, no further information has been made available. (Unknown if it is Mentor saline or silicone). Its never been ending and i cant get medical assistance to have them removed. Within 3 hours of the mammogram i felt very ill, and had hives on my torso. I started having serious difficulty breathing at all times, and especially when laying down at night. I continue with occupational therapy sessions. Right implant was found with thick fibrous capsule as well as intracapsular leak upon removal. 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. I had a 3-d mammogram and everything looked fine. I had silicone breast implants from mentor in 2013. The patient reports that the device was explanted on (b)(6) 2017. I used to be an active, social, happy, hard-working person. MENTOR MemoryGel Breast Implants and MENTOR MemoryGel Xtra Breast Implants are round devices with shells constructed from medical grade silicone elastomer. my first ones were removed via the area incision and now i have an incision in the inframammary location. The patient was implanted with mentor smooth round gel mammary prostheses on (b)(6) 2005. 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