9576298 9535778 9608402 It was reported that a female patient who underwent primary breast augmentation with mentor smooth round moderate plus profile saline implants (catalog #3502450, (r) serial #(b)(4), (l) serial #(b)(4)) in (b)(6) 2015 underwent bilateral explantation on (b)(6) 2017. Hair loss, fatigue, brain fog, weight gain. 9529874 This needs to end. 9570167 Both functional med and regular doc over (b)(6) dollars worth. My eyes were extremely sensitive to light and i had to wear sunglasses at my daughters basketball game. I had so much tissue and muscle wasting and weight loss. 9596802 9534031 The FDA has issued several warning letters in recent years to manufacturers who did not adequately fulfill certain postmarket study requirements, reflecting the agencys commitment to take more aggressive actions against manufacturers who fail to comply. Eye floaters, hip pan, can barely walk after sitting. For 10 years my body battled the toxins, biofilm, heavy metals from the implants and finally gave out trying. 9584310 Antecubital trigger thumb release, frozen shoulder release, chiropractic manipulation for several back problem etc. A lower risk of complication is rupture. 9529385 Link. All tests came back as normal. 9529112 The FDA remains committed to thoughtful, scientific, transparent, public dialogue concerning breast implant safety and effectiveness. All patients enrolled in the premarket Saline Prospective Study (SPS) will be asked to enroll in this post-approval study. 9540916 9573063 In the response to the manufacturers most recent interim study report, the FDA notified the manufacturer that the study progress was inadequate because of low follow-up rates. Finally, the FDA notified Mentor that there were significant data inconsistencies in the study, including poor patient accounting and missing race and ethnicity data. However the delay caused a potential risk to the patient. 9592613 If you have a chance, please also fill out a MedWatch Voluntary Reporting Form to the FDA with your symptoms and history progression similar to these reports submitted above so it can be documented with the FDA and then likely be submitted to Mentor. I am still trying to find if it had ever been recalled. 9590027 I have a lot of these symptoms. Lot Numbers: 9584308 9544818 This request has not been addressed as i am on medicaid. I have come to learn that these symptoms are all from the mentor saline implants done back in (b)(6) 2004, which i cannot afford to have removed. Optional: Upload attachment(Allowed file types: jpg, gif, png, pdf, maximum file size: 8MB. Manufacturer Mentor Texas, LP. Four months later, the patient underwent additional revision augmentation with unknown implant brand, texture, and fill. Severe gut pains, bone pains, swelling in hands, stiffness in legs. I cant take it anymore. Meaning, he either gave me an old implant, or a implant that was to be used for Pre-Approval clinical trial. I am now only left with ear ringing and pulsative tinnitus with sporadic muscle twitching and small bouts with anxiety. I had suffered from thyroid disease, autoimmune disorder, hashimotos and p. O. T. S. Ive had to have a full hysterectomy, remove my gallbladder, appendix, and part of my colon out, all by (b)(6). 9529875 Link. Within 6 months i developed autoimmune disorder; candida cystic acne, unexplained weight gain, cold sores, toe nail fungus, brain fog. 9616497 The data collected from this registry, have contributed to a better understanding of BIA-ALCL and FDA communication updates to the public regarding BIA-ALCL. I contacted mentor to ask about my warranty and was helped by a supervisor named (b)(4). 9555923 You can access this data free of charge via Recall Monitor, or through the Healthy Canadians website. It was reported that fill tube and check valve were missing from box of implant (b)(4) (p/n: 3502350; l/n: 7381657-018). My blood pressure is no longer high, i have zero neck or shoulder pain, and almost all of my other symptoms have went away. Im interviewing doctors to have my explant soon. After my breast augmentation, i started to get intense neck and shoulder pain along with numbness in my hands and fingers. Almost 95 percent of these symptoms have went away since i have explanted. I told him i was in severe pain, valve from implant was bothering me. Patient was required extended hospitalization. 9557442 9608063 9591674 9626607 I was given chiropractic and physical therapy treatments that did not help. I also tested positive for lyme disease. 9539274 9527436 Link. 9553339 9603190 Eczema on about 50 percent of my body as well. It was advised that once the issue was identified, the implant was sent to the back. 9531112 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. In 2011 at the age of (b)(6) i had a breast augmentation using mentor 3500cc smooth saline implants. Got saline breast implants. Lot Numbers: No family history, no alcohol induced cardiomyopathy. 9533290 Link. 9589652 9546778 9555187 Absolutely no auto immune issues in my blood relatives. 9599496 I got breast implants and theyve made me very sick. 9564915 3501610/81317001171 I had a metal taste in my mouth, tinnitus, chronic pain, chronic fatigue, depression, brittle hair and nails with ridges, +ana test, thyroid levels off and left scapular pain so bad i wanted to overdose and die. 9583024 I had mentor smooth saline with silicon shell breast implants implanted in (b)(6) 1999. 9563098 I have suffered miscarriages, infertility and severe stomach issues, ibs. The report states candida albicans in both breasts between the implants and capsules. 9598144 The addition of prescription eye drops that helped, but my eyes were still red and dry. 3503290/81317001621 3502425/81317001447 9531110 By the summer of 2015 my health had took a turn for the worse. In (b)(6) 2018 routine annual mammo showed the left breast was folding over. 3501620/81317001195 The root cause of the patients symptoms are unclear. 9630358 Unable to work. It was not feeling well at all. Ive suffered with pain and feeling like im honestly not sure that i can get through most days due to fatigue. I have actually been sick since 2004, but your calendar only goes back to 2007. I had no idea. 9577403 They are toxic in the human body and they harm babies in utero and while breastfeeding. They opened another implant for the missing items and procedure was completed. Gloves were changed, and procedure was completed with a new implant. I take vitamins and try to eat healthy. 9559142 3* *Based on key complication rates (rupture and capsular contracture). Link. 9591673 Link. 9553671 9542800 Extreme endocrine (blood sugar fluctuations). 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. No additional information has been received to date. 9565713 This needs to be recognized by the FDA and the only way for something to be done is for everyone to report it. Rx meds: none, still have implants as date hasnt been scheduled quite yet for explant. I have a high fever, infection, and valve on right breast is jabbing me. 9574051 On 2013 began the onset of several health problems that at the time, i had no idea why or what was creating all of the problems. 3503630/81317001706 Patient had implants in for 10 yrs. I am going to schedule an explant and go through detox in hopes to feel better. 9587328 I have become very clumsy, falling often, due to dizziness when i least expect it. Depression, asthma, hard time breathing at times. capsule had gone away? What is your recommendation? 9532948 I had them removed (b)(6) 2017 and have experienced major healing. 9528017 Skin wound healing problems, bleeding disorder called von willebrands and severe allergic reactions, which caused me to be on life support and no other cause. Breast implants stole 12 years of my life and i am so upset that they are allowed to be put in a womans body. 9614774 Anyone, who enters my world must be fragrance free or i get an automatic headache. I havent even had a cold for at least 2 years or more. Mentor Saline implants in 1998. Link. Other problems have been, brain fog, sad, allergies consistently, heavy periods at age (b)(6) and had to have cryoablation, cystic breasts with one biopsy (neg) and several aspirations of cysts, and finally the most recent, feeling of helplessness because of all my aching joints. 9538571 I have been feeling terrible for at least the last ten years or more. 9584035 9553110 for Recall. Up to $3,500. I lost the ability to digest meat properly, and had to eat mostly fruits, veggies and beans. While the FDA had concluded after reviewing several interim study reports submitted by Mentor that progress on the post-approval study appeared adequate at that time, the agency advised Mentor of concerns about patient enrollment, follow-up rates and data inconsistencies. 9563941 My health has been on the decline for years now. I had my explant bilateral capsulectomy 01-14-2020 and am grateful to #1 GOD and secondly to all the medical community including my dentist that recommended a TMJ Pain Specialist who made me realize I was taking way too many prescriptions over a decade and some were opiates. 9544816 Lot Numbers: As part of the Medical Device Safety Action Plan, the FDA committed to streamlining and modernizing how the agency implements postmarket actions to address device safety issues to make responses to risks more timely and effective, including taking actions against manufacturers when their postmarket studies are non-compliant with any study requirements. In 2008 she was diagnosed with anaplastic large cell lymphoma. 9602765 This felt like something physical. They lie and dismiss my issues. 9570473 9582571 9530728 9563096 I am slowly working back into exercising and my eyes are much less sensitive to light. Mentor sent an Recall Notification letter dated March 27, 2017 was sent to . I actually started feeling ill within a year of my implants. Approximately two weeks after the procedure, the patient began to experience a number of symptoms, including extreme anxiety, numbness, tingling, joint pain, brain fog, memory loss, confusion, vision problems, food allergies, difficulty walking, breathing issues, muscle atrophy and hormonal issues. I began having severe heart palpitations so i wore a heart halter monitor with no major findings. Muscle pain, back pain, gingivitis even with excellent oral hygiene. The patient underwent implantation on (b)(6) 2007. 9547974 3503270/81317001614 Capsular contracture and fungal growth were diagnosed in both breasts/implants upon explantation. 9597738 I even forgot to take my morning eye drops yesterday because they were moist and didnt hurt. MENTOR Smooth Round Saline DV Implant 350-3170/00081317001560 9579266 By this time, i had eliminated all caffeine, alcohol, and non-organic cosmetics to lower my overall toxic load. Over the past 20 year time span, I have had all over body psoriasis, chronic migraines, joint aches, left shoulder blade pain, hypothyroidism requiring meds, sinus issues, dry mouth, throat clearing, optic neuritis in my right eye, IBS, pulmonary sarcoidosis, and thumb numbness. 9550674 The follow-up confirmed that the hair was on the implant upon opening a pouch. Never was i contacted for any f/u. Some insurance companies with assist i having them removed if there is a rupture or they were implanted for reconstruction due to cancer, but i could not find a plastic surgeon that would take them out with insurance paying. 3502325/81317001409 Safety data such as reoperations, deflation, capsular contracture, and pain will be collected annually out to 10 years for each patient. The list below outlines the current status of breast implant devices and will be updated as needed. 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. As a nurse practitioner and having a physician as a husband we realized immediately that it was likely an autoimmune condition. 9550165 Link. This included all body hair (underarms, pubic, legs) as well as any head hair. 9547114 9614772 Lot Numbers: 9532946 9632676 9559883 I worked as a (b)(6) for 17 yrs but started having problems with memory resulting in mistakes in my work which had never happened before. 9541785 Sadly, I was not informed that if some of us have pre-existing conditions, it could lead to permanent disability due to chronic pain and constant inflammation with a plethora of conditions that makes ones life difficult to live on. The implants were found with faulty valves and mold. Link. He did no physical exam, but did say that he had never seen (b)(6) pay for removal. 9533840 9617814 Lot Numbers: Do you have any suggestions as I look for a doc and how to prepare for this surgery? Some patients have died from BIA-ALCL. Mold was reported in the valve and on the outside of the implant. They were smooth, round, and saline, 270 on one side and 300 on the other. 9591675 9549488 Please help me get all of this out. im so frustrated and depressed about the last 12 years of feeling horrible and i wish i never decided to get new implants. FDA Documents: Approval Date: November 17th, 2006 Recalls FDA Overview - Mentor MemoryGel [] Any problems with tissue expanders being left in for a few years. High fever, infection, and fill sunglasses at my daughters basketball game saline Study! 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