By (b)(6) 2016, i began experiencing tingling and numbness in my fingers, which was not going away. After several years of pain and discomfort and being diagnosed with sjogrens syndrome, lupus, arthritis, fibromyalgia, high blood pressure, my plastic surgeon recommends the removal of my implants. Only need to get an mri if you suspect a rupture or feel contracture. Link. Caused autoimmune diseases ana connective tissue diseases. * In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. Some of the symptoms are, joint pain, muscle pain, blurry vision, ringing in the ears, hair loss, ibs, chronic fatigue, memory loss. No deflation were found on both devices. They continue to get worse. I experience brain fog, trouble recalling words and im only(b)(6). Night sweats. Dry hair, dry skin, dry mouth, and dry nails. The fda say they are safe. A lower risk of complication is rupture. I will continue to receive services from the occupational therapist and the social worker. I know many, many(over (b)(6)) women suffering with this same situation. The following section provides links to the approved labeling and the progress of expected labeling supplements. The FDA had required this study to be done for 10 years. All symptoms started on the right side of my body, and were more severe than on the left side of my body. 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. Tell us about your purchase, including the product name, brand, store you purchased the item from, price, and date of purchase. I was fine for the first two years. Link. I had mris to check for issues with neck- diagnosed at first as herniated discs but then as arthritis. We began to wonder if my illness could have something to do with my implants. They are supposed to last 10 years. The patient must be given the opportunity to initial and sign the patient decision checklist and it must be signed by the physician implanting the device. Besides seeing my primary care physician, i have seen a neurologist, rheumatologist, holistic/functional medicine, gynecologist, dermatologist, psychiatrist, therapist, chiropractor and have tried massage therapy, acupuncture, sauna, and more recently i saw a doctor at (b)(6) for heavy metal issues. Patient had implants explanted on (b)(6) 2016. Dense breast tissue was confirmed by ultrasound. No contact information was provided in mw report, therefore no further information has been made available. 3 Multiple attempts have been made to obtain clarification on catalog, lot number and manufacture site of the devices that were used during this procedure. I want them out but cant get them out because I do not have health insurance. This somewhat lessened some of my symptoms but i still felt sick like i was dying slowly. The shell is filled with MemoryGel, Mentor's proprietary formulation of silicone. 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. 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. k-9(J((5*k?aT/SZ D z:Trx%(o8L?h{C5t*Q Right implant was found with thick fibrous capsule as well as intracapsular leak upon removal. For more information, see FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants. Have had blood tests where discovered i had thyroid issues and then found out i had hashimoto. I felt like i was dying. 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. Over the next 3 years my health steadily declined with unexplained symptoms. Focus Group Study: This study used 35 women to evaluate how patients understood the safety and labeling brochures. Manufacturer requested implant and packaging directly from or team to investigate. At present, i cannot sit for long, tire easily and cannot drive far. Link. 1 MENTOR Breast Implants are backed Some days cant get out of bed. I have been to the er several times because i was choking at that time i was using a solution to help clean out my sinuses, i dont realize it was causing me to feel like i was choking even more. They were smooth, round, and saline, 270 on one side and 300 on the other. I happened to notice that one of my breast implants (from breast cancer in 2000) had gone flat. The patient reported to have several undisclosed illnesses within months of getting the implants put in. I have been on a detox diet since (b)(6) 2016. I had a 3-d mammogram and everything looked fine. Fast--You don't have to spend hours trying to solve the issue, Easy--You don't have to struggle to fill out tedious forms or keep track of all the steps involved in solving your problem, Successful--You can rest assured knowing we'll make the best case for you. Awareness of possible symptoms and side effects resulting from defective breast implants is also relevant for the health and safety of anyone with a Mentor implant. Now i have white-ish pus discharge (fungal infection), extreme pain/burning in both breasts as well as numbness/tingling/burning sensation in arms/shoulder, grade #4 capsular, contracture, trouble breathing properly, memory loss/brain fog, blurry vision, swollen throat lymph nodes, loss of motion in both arms, major teeth issues due to implants, leaky gut/ibs, extreme anxiety and depression, bed ridden, muscle pain, unknown opage spots on breast ultrasound, candida issues/fungal issues/bacterial issues, muscle loss, extremely achy joints, massive fatigue, sinus issues, migraines. Chronic pain, chronic fatigue, cognitive dysfunction (brain fog, difficulty concentrating, word retrieval, memory loss, difficulty processing information), muscle aches, pains, and general weakness, joint pain, dry itchy eyes, easy bruising, loss of sex drive, inability to sexually perform, shortness of breath, night sweats, hormonal imbalances, tingling and numbness in arms, hands and fingers, cold hands and feet, metallic taste in mouth, nail cracking, splitting, no growth, skin freckling, increase in papules, edema, decline in vision, digestive and gastric issues, throat clearing, difficulty swallowing and choking feeling, anxiety, depression, panic attacks. Alcl stage and alcl treatment are unknown. I finally found a surgeon who could explain why i was still acutely ill, and she was able to remove the remaining capsule and silicone, which she was able to find. 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. Mentor Texas LP. The affected consignees were notified via customer letter on 7/1/16, and a follow-up with respective sales representative via visit. It helped the pain a bit. 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. But since the surgery i feel like my lymph nodes are constantly swollen and keep struggling to fight off infections and colds. Link. Link. /f&b2jy|/ZS [=s It was reported that the patient has suffered bodily injury and resulting pain and suffering, disability, mental anguish, loss of capacity for the enjoyment of life, hospitalization, medical and nursing care and treatment, loss of ability to earn money in the future. I hurt everyday and have migraines. the Large Study) have been restructured into multiple smaller studies (Case Control Studies, MemoryGel and Shape Combined Study, Re-Op study). Chronic fatigue, weight gain, inability to be active. Link. My medical bills and trips to hospitals are out of control. Tingling and numbness in face, hands, and feet. Muffled ears like swimmers ear. Panic attacks, chest pain, breast pain, inflammation, depression. I got breast implants in (b)(6) 2011 within weeks i began feeling aches, pains, fevers, chills, racing heart, hair falling out. The patient sought treatment from several physicians, who concluded that the implants were responsible for patients condition. Within the past 8 months i heard about breast implant illness, i do believe i suffer from it. I had informed the technician that i had them. The new labeling approved on October 27, 2021 follows from the labeling recommendations described in the FDAs September 2020 guidance. 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. What they are clear about is that i have autoimmune/inflammatory issues in addition to memory issues/brain fog. Went through chemo then had a stem cell transplant in (b)(6) 2016. Fatigue was addressed with a suggestion to get more sleep. Eventually by 2007 both implants were capsulized. 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. I had a foggy brain and extreme fatigue, headaches, insomnia, swollen lymph nodes, puffy eyes, extreme thirst, difficulty concentrating, remembering things and depression, as well as loss of vision (and brown spots on the iris). 350-2275 Re-Op Study: This studywill collect data when a participant from the original Large Post-Approval Study with MemoryGel breast implants requires a secondary procedure/reoperation. )7:Evvc},,dK9%"Ty.73&X6H(TQzz?n7?"=O[U? The surgeon noticed a piece of plastic that was attached to the outside of the shell. My diet is impeccable, the products i use on my body are as clean as it gets- completely 100% organic, all natural, no preservatives, etc. 350-1645 However i had in 2010 began to be diagnosed with many more autoimmune disorders. From the middle of (b)(6)(the date my plastic surgeon explanted the implant), i became so debilitated that i could no longer walk. Patient was scheduled to have mri exam later. Link. Breast implant manufacturers may need to update product labeling as the FDA learns new clinical information. Implant provides the natural feel patients desire with increased form stability to shape the breast. Thank you for the many experiences posted. Menstrual period only twice or so a year (started in 2008 after implants). The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates. q@8mhD";BN"z\h[-1k90p UpK&uEO`W4]76 $gQsB#ZYWG[1!EMd[O'teY3c[UhgE?_u `6 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. (Unknown if it is Mentor saline or silicone). I was diagnosed with hashimotos thyroiditis 3 years ago. waiting for scheduled explant and lymphadenotomy when i will be hospitalized. Manufacturer Mentor Texas, LP. All rights reserved. C reactive protein is measuring 48 or higher. The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates. Cant handle the sun anymore, can no longer jog/run. Link. I got severe spinning vertigo that lasted 6 years. Patient suffered pain on the left side for the past year and it was getting worse. I was extremely healthy at time of the implant surgery and was told these were fda approved and very safe. 350-1610 Mentor MemoryGel (Premarket application number: P030053) (Approved November 2006) Description and Detailed Information Links: Mentor's MemoryGel Silicone-Filled Breast Implants have a. 350-2350 Loss of interest and pleasure in doing activities. It is one of 2 ablations in less than a year. Besides developing multiple food sensitivities, i have also developed an extreme sensitivity to mold and chemical exposure. (Unknown if it is Mentor saline or silicone). Instructions for Downloading Viewers and Players. UkEq5LuEBf&ei'FKNl, @HfoB}S#L +nj^yJnJ(k7D?$$$# 10. 3 350-2225. (Unknown if it is Mentor saline or silicone). endstream endobj startxref 350-3270 Irvine, Calif., (January 13, 2021) - Mentor Worldwide LLC, the number one global brand in breast aesthetics, and part of the Johnson & Johnson Medical Devices Companies** today announced that the U.S. Food and Drug Administration (FDA) approved the MENTOR MemoryGel BOOST Breast Implant for breast augmentation in women at least 22 years . 350-1655 11. Contact the manufacturer if you require additional information. Link. Link. These were conditions of FDA approval and were required by theApproval Order. No reports of rupture or other product issues. The mammogram film showed the bursting of the implant. Link. The patient believes that the discoloration is a fungus growth inside the right device. I am as active as i possibly can be, but lately it has become hard- i am always tired! Damaged/faulty implants have ruined my health and many aspects of my life. 350-2275. Posting Date. Hypothyroid, coughing, intolerant to heat and cold, new and persistent viral infections, candida, constant yeast infections. Link. I was convinced that the implants had ruptured even though it didnt show up. UT]b$c} I even contacted mentor and the fda via email before and neither seemed to care. Case-Control Study:Terminated. There is original labeling (at the time the FDA approved the implant) and current labeling that is updated with post approval study information and to adequately communicate the risks. 5. 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). So, i began my research for answers. In 2014 i started to get swelling in my fingers and toes. I began having rheumatoid symptoms inflammation, huge knots popping up in various joints, pain on level 10. I can hardly walk, my knees lock up, and i am only (b)(6), depression at times, due to weakness. Link. Mentor stands by its textured implants and says the cancer is "rare" with its product. . Brain fog, memory loss, muscle pain, weakness, joint pain, dizziness. Link. This began to get out of hand this (b)(6) and i began to research to figure out what was going on. I feel my breasts are ruined forever now. The changes i have had in my body in the past 15 months have been so drastic for me. Link. In doing my research, i trusted the fdas recommendation that these were very safe implants. Link. My body couldnt sweat couldnt get rid of toxins. Note: If you need help accessing information in different file formats, see I thought maybe an expander that would be placed between the muscle and tissue to push the muscle back down to the chest wall or maybe stitches to stick the muscle back down so that its not pulling the breast tissue when i flex. Over time, the number of health concerns increased or became increasingly worse. I dont even know how to put it in words. I have hot and cold sensitivities. No money and insurance will not cover? Polycythemia vera rubra. Link. 350-1660, SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT W/DIAPHRAGM VALVE, 350-2200 Upon further inspection of the inner shell, the surgeon noticed black specs floating in the fluid. I have a supportive husband and family and have even resigned from my teaching position to help figure out my medical issues. Link. Lowered immune system, and i get sick (strep throat, colds) and i never used to, slow clearing of colds. I have arthritis and thyroid issues. Here are my symptoms: hormones are imbalanced (out of wack), hypothyroid. Mri confirmed that bilateral implants were ruptured. I am the poster child of healthy. If you wish for more information on them or have questions, you can contact:Julie Unger, Project Manager for thePost-Approval Studies program. 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