Link. in this way, she confirmed that it could be breast implant illness that i was suffering from. I was shocked as nothing like this was ever heard of in my family. My medical bills and trips to hospitals are out of control. 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. 350-2300 Extreme fatigue, loss of concentration, memory loss, along with brain fog, confusion and cognitive dysfunction. DoNotPay can assist you with a simple, easy-to-use process in one place. I was diagnosed with alcl in 2016. Medtronic and adrenal issues. Ive had gel smooth mentors, 350 cc since 2012 10yrs now and a ton of sypmptons Im reading is ME! I have mentor breast implants for reconstruction from cancer 2015. Here are some examples of our many recall request assistance programs. There are 20,000 of us there with the same stories. 350-2250. I am ASAP to get my life back! I started in (b)(6) going to doctor. In (b)(6) 2014, both ruptured implants, damaged lymph nodes, affected chest muscle, and surrounding tissue (to my chest wall) were removed during a 7 hour surgery. I asked doctors if it could be my implant and they told me, no. Multiple attempts have been made to obtain clarification on this event. MENTOR Breast Tissue Expanders. Patient also had delayed wound healing, infection, lymphadenopathy on the left side. . Dermatologist and allergist were seen without relief. The hospital has denied the mammogram caused the rupture but both at the same time is so obvious. It was reported that a (b)(6) year-old female underwent primary augmentation surgery using mentor silicone implants. I had breast implants on (b)(6) 2016. I grew increasingly weaker and more ill. Link. Link. Link. Recalling Firm. Sit back and relax while we do the work. 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). It took me that long to convince my doctor that something was wrong!!!! Breast cancer in 2000, so i chose reconstruction with saline implants. I am so tired of missing out on life due to the way I feel. endstream endobj 310 0 obj <>stream If a patient declines to provide personal, identifying . 350-3290 Link. Research needs to be done. Many test to follow. Abnormal blood test results since 2012. Was rushed to surgery, large hematoma was removed and hospitalised for several days. The patient sought treatment from several physicians, who concluded that the implants were responsible for patients condition. I believe as i stated before they have exacerbated my autoimmune challenges. hb```l@(0>.JO;%.mP'cGGE[GCKGGG>aS4FeX#aD{9L'0baZ\C@Ib @w?Vf . A lower risk of complication is rupture. 325 0 obj <>/Filter/FlateDecode/ID[<4FD22ED3B7DCE845A6E6AEF3AE0F309B>]/Index[304 37]/Info 303 0 R/Length 103/Prev 225431/Root 305 0 R/Size 341/Type/XRef/W[1 3 1]>>stream Smooth surfaced implants are not affected by. Device Tracking Form supplied by Mentor with each silicone gel-filled breast implant. Alcl stage and alcl treatment are unknown. 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. 350-3230 Since this event involves device sterility and could have led to an adverse event or serious injury, it is considered serious and mdr reportable. Difficulty sleeping. Mentor is commited to product safety. No deflation were found on both devices. Metalic taste in my mouth. Within a year, i began to experience headaches, fatigue, chronic joint pain in left side of neck, shoulder, hip, knee, brain fog. April 2013. Started feeling ill within a year, by year 3 i was so sick my labs pointed to lupus or sjogrens. The section below provides information and links to the original labeling and updated labeling for each approved breast implant. Shortly after, i began to experience a myriad of unexplained symptoms including anxiety, thyroid levels off, debilitating fatigue, dry eyes, blurred vision, brain fog, dizziness, etc. Thoroughly screened blood tests, mri, ctscan, ultrasound, endoscopy and colonoscopy. Heart palpitation, swollen and tender lymph nodes in breast area, underarm, throat, burning sensation around breast implant and arm pit, bladder pressure pain. This is so my body can have an opportunity to try and heal and settle down from all of the reactions my body is experiencing. A bilateral breast mri was done on (b)(6) 2017 due to recent diagnosis of left breast cancer (exact date of diagnosis is unknown) the mri was done to assess extent of disease and for possible contralateral disease. No improvement with nsaids (multiple tried). The symptoms are all still there and the issues persist despite medication and extreme lifestyle and diet overhaul. Approx 7 years ago, i had a breast augmentation done, re-done actually. During a bilateral breast augmentation, the implant that was to be used for the right breast was discovered to have/contain foreign material. I the implants were never soft and felt artificial. it was a walk in the park! This final guidance contains recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants. I was in extreme pain, and i began losing my hair. Loss of interest and pleasure in doing activities. I even contacted mentor and the fda via email before and neither seemed to care. I told my plastic surgeon about it, said i was concerned but he brushed it off and said it was not related, even though it began right after implantation. Link. Updated silicone gel-filled breast implant rupture screening recommendations. Shortness of breath (feel like i cant catch my breath). Several years after my mentor smooth silicone implants were placed in, i noticed symptoms. Now i am homeless. Conclusions: Mentor MemoryGel Silicone Breast implants represent a safe and effective choice for women . Released and left breast began to swell, i ran a fever, chills, severe headache behind my eyes, nausea, fever. aJXtf"N2{7c1[>>Cl|4^LTA-L[fd-"e1[1X8x4F7m$98/lU ? Saline-filled breast implants are firm to the touch while gel-filled implants mimic the feel of fat in a patient's body. 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. Summary of the Safety and Effectiveness of Mentor's MemoryGel Silicone GelFilled Implants in Patients who are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, or Revision. Link. I experienced horrific pain, consulted with pcp who ordered x-rays that showed no rupture. Cant wear socks or shoes only flip flops. Sensitivity to heat, sunlight and florescent lighting. 350-3330 Link. 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. Feet red swollen to deformity. Dryness of mouth, hair, skin, and scalp sores, choking at night afraid, i wouldnt wake up. Caused autoimmune diseases ana connective tissue diseases. 3 Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. Adjunct Study Final Report for Mentor's MemoryGel Silicone GelFilled Breast Implants, 02 November 2012. 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. Since explanting, i already am noticing symptoms subsiding such as my brain fog, temperature regulation and ability to focus clearly. Something needs to happen you have dropped the ball on this. Skin rashes only getting worse and slight fibromyalgia diagnosed by dr. (b)(6). I'm a 34 C with my implants. I have seen 10 doctors over the past 3 years and i have been able to manage, but most of my symptoms remain at large. Please help me before i lose my life. 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. The patient reports that the device was explanted on (b)(6) 2017. Over the past 3-4 years, the intensity of issues has become severe. Bia alcl swelling around implant need aspiration. By (b)(6) 2016, i began experiencing tingling and numbness in my fingers, which was not going away. I have been to several drs and surgeons who thankfully acknowledge implant illness and i am on my way to having implants removed next month. Learn More Available in a Variety of Options for Projection and Fullness MemoryGel BOOST Breast Implants MemoryGel Xtra Breast Implants Choose whether you want a refund, repair, or replacement. On (b)(6) 2015 i had woke up to a horrible pain, ended up capsular contracture grade 4 (baker), then ended up ruptured right breast tissue and implant as well as the following: fatigue or chronic fatigue, cognitive dysfunction (brain fog, difficulty concentrating, word retrieval, memory loss), muscle aches, pain, and weakness, joint pain and soreness, hair loss, dry skin, eyes, mouth, hair, weight gain or weight loss, easy bruising and slow healing of wounds, temperature intolerance, low libido, ringing in the ears, heart palpitations, photosensitivity, shortness of breath, metallic taste in the mouth, oral thrush (white tongue), night sweats, skin rashes, insomnia, estrogen/progesterone imbalance or diminishing hormones, swollen and tender lymph nodes in the breast area, underarms, throat, neck, or groin, tingling or numbness in the arms and legs, burning pain around the chest wall or breasts, cold and discolored hands and feet, foul body odor, muscle twitching, dehydration, frequent urination, chronic neck and back pain, nail changes (cracking, splitting, slow growth, etc), skin freckling, pigmentation changes (darkening or white spots), or an increase in papules (flesh colored raised bumps), edema (swelling) around eyes, premature aging, decline in vision or vision disturbances, liver and kidney dysfunction, digestive and gastrointestinal issues, food intolerances and allergies, smell or chemical sensitivities, new or persistent infections viral, bacterial, and fungal (candida), reoccurring sinus infections, throat clearing, cough, difficult swallowing, choking feeling, chronic inflammation, feeling like you are dying, headaches, dizziness and migraines, mood swings, emotional instability, anxiety, panic attacks, suicidal thoughts, depression, hypo/hyper thyroid symptoms, hypo/hyper adrenal symptoms, symptoms or diagnosis of fibromyalgia, symptoms or diagnosis of lyme, common autoimmune disease, 33 different metals and chemicals including silicone. I was unable to walk or open windows or cupboards. Ive been sick ever since. This is five years of my life i cant get back. It was reported that one female was implanted with mentor silicone breast implants in 2006. Link. Within several months i developed capsular contracture in r breast. 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. My right mentor high profile silicone breast implant shell has completely disintegrated, implanted in 2012. In 2006, contacted my plastic surgeon and was told fda had approved a silicone implant for breast cancer patients, so i met with a mentor representative that explained the study i would be required to participate in if i chose these specific implants. 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. This impact is widespread and debilitating. Muffled ears like swimmers ear. Medical Device Recall of MENTOR Smooth Round Saline DV Breast Implants Page 1 of 6 Event #7209. Have had multiple visits to the ent and walk in clinic. From that time on, i developed more and more symptoms that piled on top of each other. Case-control studies were later terminated after the release of Tuftss evidence report. Polycythemia vera rubra. Link. I have a supportive husband and family and have even resigned from my teaching position to help figure out my medical issues. Ringing in ears, metalic taste in mouth, skin rashes bug bites, scratches and other wounds take forever to heal. 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. H\j >wIJ$PC$uBS{+{0inepKg& A5 vOg+:{\(mADuXx:EyyCHpuD?(h .4ZF?f83QEmQP >g>?4)0QgM5MqM7*z Y I began having rheumatoid symptoms inflammation, huge knots popping up in various joints, pain on level 10. 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. These are not safe. I was implanted with mentor memory gel silicone breast implants. MENTOR MemoryGel Breast Implants and MENTOR MemoryGel Xtra Breast Implants are round devices with shells constructed from medical grade silicone elastomer. The implants are scheduled to be removed on (b)(6). I went to the er, where they werent sure what was wrong and gave me antibiotics, which had no effect. Initiating a recall claim for a Mentor implants recall can be a stressful process on top of what is already a stressful situation. Mentor strongly recommends that all patients receiving silicone gel-filled . I have mentor cohesive gel breast implants and experienced symptoms almost immediately. I have heart issues, fatigue, high metal to city that can lead to significant cardiac issues. I know many, many(over (b)(6)) women suffering with this same situation. Thank you for the many experiences posted. A lot of my symptoms have improved or disappeared after removing the implants. I would give anything to have my life back. After 2nd scar revision surgery, breast tissue was sent for pathology and she was diagnosed with implant-related anaplastic large cell lymphoma on (b)(6) 2017. Conclusion on calcifications was bi-rads category: 0- incomplete: needs additional imaging evaluation. MENTOR Warranty 2 Shame on the implant companies, shame on the FDA and shame on doctors who dont give you enough information!!!!!! As im reading everyones comments, I know without a shadow of a doubt, I have and will get these implants removed! 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. At this point, it had been about 9 months of sustained acute illness. PMAs with Product Code = FTR and Original Applicant = MENTOR CORP. Autoimmune diseases are often caused by external reasons, and are not always hereditary. Could barely walk. They continue to get worse. Extreme chronic fatigue, atypical connective tissue disease, breathing problems laying down. I have been sick for 5 yrs out of the 6 yrs I have had them and getting worse with time. Link. 11. I contacted a plastic surgeon at (b)(6), and scheduled an explant. Link. Breast implant labeling is provided to ensure a patient receives and understands the benefits and risks of these devices. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruc. Link. I had reconstruction due to breast cancer with mentor memory gel silicone implants 300cc. I was a very healthy, active person up until all of this happened. The pharmaceutical company Allergan has recalled all BioCell textured breast implants at the request of the US Food and Drug Administration (FDA) because they have been linked to a rare type of lymphoma: breast implant associated anaplastic large cell lymphoma (BIA-ALCL). 200 cc both sides b cup to c cup. I have been ill since having silicone implants fibromyalgia, sleep disorder, pain in neck, shoulders, hips, legs, feet, and back. 350-2425, SMOOTH ROUND HIGH PROFILE SALINE-FILLED MAMMARY PROSTHESIS, 350-3210 You should hear back from the company directly with confirmation and how they will issue the refund or replacement. Since the removal of the implants, i have had 2 addl reconstruction surgeries including a latissimus flap. they have slowly been poisoning my body. Pathology and currently waiting to explant. So many women are sick and get better after explant. On (b)(6) 2009 is the date i had surgery to have implants. 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. 350-3310 We have helped over 300,000 people with their problems. I have pictures, notes and many bills. My body couldnt sweat couldnt get rid of toxins. I suffered from chills, hallucinations, elevated blood pressure, fatigue and diarrhea. Had vertigo for over a year, tinnitus, debilitating fatigue, depression, anxiety hair loss, weight gain and loss for no apparent reason, heart palpitations and chest pain, rashes, shingles x3 over the past year. Link. I have breast implants and they are causing chronic inflammation in my body leading to various health conditions even to hospitalization. Then upon investigating, i found that all of my symptoms were related to silicone poisoning due to ruptured implants. Auto immune disease, hands were swollen, red, and itchy. Site of lymphoma: right side. In 2016 i had a breast reduction with old implants removed and new implants to put in. The new labeling approved on October 27, 2021 follows from the labeling recommendations described in the FDAs September 2020 guidance. I havent even had a cold for at least 2 years or more. There was no patient contact reported. . 5. 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