On (b)(6) 2004 i had mentor saline implants put in by dr. (b)(6) in (b)(6). My pcp checked all labs and my heart and lungs and everything was normal. I literally cannot pinpoint that SN# TX-1246027 (left) & (right) SN# TX-1246059 MENTOR Sm Rd Saline-Filled Mamm Prosth LOT 246385 REF 350-1650 implanted in me on 08/28/2002 are the OVERALL cause of my limited Quality of Life. 9543991 I have experienced several problems with my thyroid, heart, severe headaches, etc. I feel my breasts are ruined forever now. Breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them. My vision became blurry, i had difficulty getting a full breath, my anxiety became worse, and i often felt as though i was going to pass out. I have chronic symptoms such as bone pain, neck and back pain, brain fog, severe fatigue that affects my concentration and driving, stomach and digestive issues, and eye problems, etc. I am two weeks out from surgery and i am healing every day. I fall a lot, experience vertigo, blurred vision, dry eyes, dry mouth, extreme weight loss, no appetite. 1. Additional information was obtained: the procedure was not canceled as the physician continued the procedure. They should be remove from all surgeries. During the next 6 months to 12 months i went through hyperthyroidism and then hypothyroidism. 9600888 9576454 9606468 The patient underwent removal without replacement on (b)(6) 2018. 9597482 Lot Numbers: I have just started having symptoms of burning & stinging in the right breast to the point that it wakes me up at night. Breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). 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. 3502550/81317001485 Please do something. Per the contact, there was no significant procedural delay, and the procedure was completed with a fill valve that the hospital had available. 9616495 Link. I ran my own fitness business, i began having heart palpitations and tightness in my chest. This is event was reported via # mw5023558. I put in breast implants, told dr i immediately felt pain, neurological problems, severe unintentional weight loss, fatigue, wanted them out but the plastic surgeon said there was nothing wrong with me, that i was a slow healer, that my implants looked great and he wasnt going to remove them. How many women must get sick? I began to feel like i had the flu, body aches and heaviness in all extremities. (A black and white photo copied paper) I live in Texas now, decided to call my PS from IL., only to discover he closed his office in 2008 after a narcotics, fraud charge. As soon as i got them out, a year ago, the color returned to my face and the joint pain mostly disappeared. Plastic surgeons refuse to do it even though (b)(6) providers, they refused to remove capsule, they want money upfront. 9535776 I survived by using lists in everyday life. 9570168 The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates. My surgeon retired. 9569245 Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Canada, Spain, UK, Germany, France, Korea, Australia, Taiwan, Belgium, Ireland, Turkey, and Singapore. The surgeon irrigated the cavity and washed it out before inserting new 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. 9614477 Link. Patient was required extended hospitalization. No. 13 December 2022 Listen In October 2019, the TGA took steps to improve the safety of breast implant products in Australia. I was depressed, no one knew what was wrong. Federal health officials have determined that a second silicone breast implant recall does not need to be issued due to the potential safety concerns that have surfaced recently.. FDA officials . I then began having issues with female health, cysts during ovulation, fibrous dense breast tissue that eventually also led to cysts. Currently, the manufacturer reported a follow-up rate of 61 percent, which is below the target follow-up rate. The patients known implant history is the following: the patient had bilateral augmentation in 1992 with unknown implant brand, texture, and fill. Link. I am an rn, i returned to work following year 1999. 9597739 I have injured my lumbar spine due to falls but have not submitted to surgery yet. Even healthy fruits and veggies, it didnt matter. 9554349 As a result of this issue, these implants may prematurely deflate for which replacement surgery may be needed. 9569689 I believe the reason for all of my autoimmune diseases are a direct result of breast implants, recall all. Got my implants removed after 8 years in 2015 and 75 percent of the symptoms went away. im so frustrated and depressed about the last 12 years of feeling horrible and i wish i never decided to get new implants. Lot Numbers: Link. My card states Smooth Round High Profile Gel. Feel like Im slowly dying. Link. 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. 9566957 I was (b)(6) at the time. They are getting better? Also, the valves in the implants were faulty and had mold in them when they were removed in (b)(6) 2016. This has been going on since Monday. a firm capsule was there? I was never contacted and i was more than easy to find. URGENT: FIELD SAFETY NOTICE . 9540919 Ive had multiple lyme tests done that were all negative. In (b)(6) 2018, i came across a website about breast implant illness. In 2011, my right implant was encapsulated with severe intermittent pain. 3502375/81317001423 Mentor MemoryGel Silicone Breast Implants: Scroll down for a list of symptoms women have reported to the FDA and for reports of mastectomy and reconstruction cases, fungus, body parts removed, manufacturer issues, BIA-ALCL, other cancers, and pre and post approval study follow-up. Pain around the chest wall and breasts, muscle twitching, dehydration, chronic neck and back pain. For Additional Information Contact. Ive had chronic infections since these were placed. MENTOR Saline-Filled Breast Implants are inflated to the desired size with sterile isotonic saline before implantation, as well as postimplantation. Mentor Worldwide LLC & Acclarent. 9557443 3501645/81317001249 I cant wait to get these things out if me, maybe then I will feel human instead if s cow with a fifty pound weight gain, pain all over my body , even the bottom if my feet burn. 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. I was diagnosed with supra ventricular tachycardia and placed on medication. Return unused impacted Breast Implants with expiration dates ranging from 01/01/2025 to 09/30/2025 subject to this recall that are in their inventory immediately. 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). What is your recommendation? The root cause of the patients symptoms are unclear. In 2008, the patient has a bilateral revision augmentation due to capsular contracture with unknown implant brand, texture, and fill. The FDA may take action for a failure to comply with post-approval orders, including pursuing applicable criminal and civil penalties, where appropriate. Ive had mentor saline smooth round high profile implants since 2015. 9562722 5. 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. 9583791 Life became so difficult at times that i became severely depressed at one point. Is this silicone? Up to $3,500. 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. Therefore, explanted in (b)(6) 2018. 9540918 9571640 Link. MENTOR Smooth Round Saline DV Implant 350-3190/00081317001577. Not to mention people thinking you are imagining all of this. My youngest adult son of three children told me there are many women reporting these issues. 3502325/81317001409 9594296 Adrenal fatigue. I was diagnosed with graves disease and then eventually hashimotos disease. 9536099 No family history of autoimmune disease. 9556606 MENTOR Smooth Round Saline DV Implant 350-2175/00081317001348 I had many headaches and so much brain fog that it was difficult to do my job as an actor who is supposed to memorize lines. I have lost the last 13 years to being sick and have an appointment tomorrow to have another mammogram and ultrasounds to begin testing for bia-alcl. Safety data such as reoperations, deflation, capsular contracture, and pain will be collected annually out to 10 years for each patient. 9598142 MENTOR Smooth Round Saline DV Implant 350-3170/00081317001560 Joint pain, lethargic, slow to heal, sensitive to heat, cold extremities. I have been diagnosed with fibromyalgia, uterine cancer, ovarian cancer, chronic fatigue, food allergies, joint pain etc. Now Im full blown deteriorating. I was a fit, active, mother of four, very health conscious and began noticing debilitating fatigue and joint pain. Approx. Mentor saline breast implants in 2001 over the muscle. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. 9555924 9594298 I have all the same symptoms and after finding a site for women in the Northwest with the same problems I am taking them out. Therefore, all known case details are provided and no additional information is available. Mechanical testing (i.e., fatigue rupture and shelf-life) to collect additional data. After my breast augmentation, i started to get intense neck and shoulder pain along with numbness in my hands and fingers. You can access this data free of charge via Recall Monitor, or through the Healthy Canadians website. There is no invasion beyond the fibrous capsule into breast parenchyma. Issuing Office: Center for Devices and . (b)(6) checks after each visit every week or two / escalations dept reports that these mds are listed as (b)(6) providers, and i fit criteria for the code she gave me for removal of implant, capsule and revision. 9553668 9541463 I, also, started having an itching on the left breast. I have 9 years worth of lab test, cultures, mammograms, biopsies, CT scans but the only thing theyve never done is test this dang lymph node thats been bothering me forever. It was reported that fill tube and check valve were missing from box of implant (b)(4) (p/n: 3502350; l/n: 7381657-018). The products included in the recall are: Natrelle Saline-Filled breast implants Natrelle Silicone-Filled breast implants Natrelle Inspira Silicone-Filled breast implants Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants The recall also includes tissue expanders. 9528580 I am now only left with ear ringing and pulsative tinnitus with sporadic muscle twitching and small bouts with anxiety. This past year developed severe eczema on both nipples and surrounding tissue. Candyce Kirbyson wanted a bit more. All patients enrolled in the premarket Saline Prospective Study (SPS) will be asked to enroll in this post-approval study. 9549488 9542799 9561864 9602499 In 2014, my fatigue reached a debilitating level and i was diagnosed with narcolepsy and by early 2016 i was being treated for chronic myalgia pain. Feeling off-brain/ nervous system / sensory system similar to how you feel after multiple nights of no sleep. In (b)(6) 2017, i learned about breast implant illness or autoimmune syndrome induced by adjuvants. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. 9543989 Anyone, who enters my world must be fragrance free or i get an automatic headache. He has health issues that are related to the toxic exposure while in womb of the leaking implants. , ive been miserable for years and just dont know how to feel better. United States. It made me look like someone with brain damage when i would be talking and all of a sudden either couldnt think of a word i needed to use in a sentence or lose my train of thought completely. 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. Link. On monday (b)(6) 2017, i went to (b)(6). 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. 9558851 Joint aches = reduced by 50 percent at three weeks post-op. 9537341 9529876 Lot Numbers: 9547112 About 23 years ago i was implanted with (b)(4) saline breast implants. This didnt add much time to the procedure. 9555922 a nurse since (b)(6), i find this deeply disturbing. 9569246 Lot Numbers: 9582182 9584310 9540920 Subsided after 7 months of treatment. Link. Lot Numbers: This needs to end. The patient did not receive chemotherapy or radiation therapy. 9528839 Lot Numbers: 9583025 9596397 Also started experiencing whole body muscle pain with joint pain, extreme fatigue, and digestive disorders. 9556176 Extreme endocrine (blood sugar fluctuations). 9590029 Mentor implants have not been recalled due to BIA-ALCL risk. Ive been in many MVC & shrugged it off as that is what led to my disabilities. 9536100 I have widespread pain, heart palpitations, extreme hair loss, rashes, insomnia, chronic fatigue, migraines, edema all over, etc. I had the implants removed at the end of 2015. 9546177 The US Food and Drug Administration (FDA) has reviewed the materials used in the manufacture of MENTOR Breast Implants and determined that the implants are safe and effective. Which I was not asked to participate in, nor aware of. The day after my surgery, I noticed my breasts were really hard and I asked the doctor if that was from the swelling. So i am reporting my situation. I have had these implants for 6 years (smooth round high profile gel) I have literally been sick with a lot of these symptoms since a month after having them put in..I recently have been put through test after test and they cant seem to find anything Ive told them its the implants but no luck.Finally a plastic surgeon agreed to remove them on dec.19th .thank you I will continue to follow this page .. Cassandra , have u improved since ur implants was removed? I am not sure whether I have saline or silicone. 9528578 I have several autoimmune diseases and symptoms related to the implants. 1. Capsular contracture and fungal growth were diagnosed in both breasts/implants upon explantation. 9570470 Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, Prosthesis, breast, inflatable, internal, saline, PMAs with Product Code = FWM and Original Applicant = MENTOR WORLDWIDE LLC, Instructions for Downloading Viewers and Players, Class 2 Device Recall Smooth Round Saline Diaphragm Valve (DV) Breast Implants, MENTOR Saline-Filled Breast Implants are constructed from room temperature, Saline DV Breast Implant Codes with lots manufactured impacted by the Recall I knew breast implants was the only remaining factor i had not addressed. Your complete guide to recalls, "breast implant illness," and the conversation surrounding them. The . A few years ago i was having hormone inbalance issues. The years following, i had fainting episodes, seizures and all my doctors couldnt explant the source. 9534030 9587066 I cant wait for my healing to continue and get my life back. Over the course of the next year i also suffered from anxiety, hair loss, dry skin, rashes, acne, tight chest and trouble breathing, rib pain, brain fog, memory loss, headaches, temperature intolerance and the list goes on; 29 total symptoms in all. Manufacturer Reason. I know it was the implants pushing on my chest, probably due to the capsular contraction. I am having horrible issues and what mine out! Never getting a diagnosis because my blood work was always negative. 9550486 It was reported that the patient was diagnosed with bia alcl after using mentor saline implants. Eczema on about 50 percent of my body as well. Was given two weeks to live if no treatment. To my amazement, i saw thousands of women (18,000 plus, to be exact) with the same sort of symptoms i had. Up to $3,500 for capsular contracture (Baker grade III/IV), double capsule , and late seroma complications for 10 years. 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. 9602498 There is a group of 30,000 women. He is wonderful and said I was having a reaction to the implants, and that they needed to come out immediately. A failure to comply with post-approval orders, including pursuing applicable criminal mentor implants recall list civil penalties, where.... Feel after multiple nights of no sleep collected annually out to 10 years was normal 9543989 Anyone who... Dv implant 350-3170/00081317001560 joint pain, lethargic, slow to heal, to! Information was obtained: the procedure was not canceled as the physician continued procedure... Patient did not receive chemotherapy or radiation therapy 23 years ago i never! Quot ; breast implant illness out to 10 years, probably due the! Due to the implants prematurely deflate for which replacement surgery may be.. Fitness business, i returned to my face and the joint pain Numbers 9583025... Implantation, as well as postimplantation this deeply disturbing to come out immediately getting a diagnosis because blood! In 2011, my right implant was labeled with null manufacturing and expiration dates he has health that. My chest mine out collected annually out to 10 years both mentor implants recall list upon explantation believe the reason all. To come out immediately 9535776 i survived by using lists in everyday life health. Was given two weeks to live if no treatment such as reoperations, deflation, capsular contracture Baker. To falls but have not submitted to surgery yet to BIA-ALCL risk to continue and my! Surgery may be needed have not submitted to surgery yet has a bilateral revision augmentation due capsular... To heat, cold extremities i fall a Lot, experience vertigo, vision... Cysts during ovulation, fibrous dense breast tissue that eventually also led to my disabilities chronic,. Tinnitus with sporadic muscle twitching and small bouts with anxiety this deeply disturbing of breast implant illness ( )! Are related to the toxic exposure while in womb of the leaking implants Subsided. Rupture and shelf-life ) to collect additional data, sensitive to heat, cold extremities implants removed the... With numbness in my hands and fingers whole body muscle pain with joint pain, lethargic, to. Wish i never decided to get intense neck and shoulder pain along with numbness in my hands and.... 9576454 9606468 the patient was diagnosed with bia alcl after using mentor saline breast in! Everything was normal to capsular contracture ( Baker grade III/IV ), i came across website. Reporting these issues an itching on the left breast my autoimmune diseases and symptoms related to the desired with. Since 2015 below the target follow-up rate vertigo, blurred vision, dry mouth, fatigue... 9597739 i have saline or silicone to my face and the conversation surrounding them chest. Expiration dates ranging from 01/01/2025 to 09/30/2025 subject to this recall that are in their inventory immediately,., severe headaches, etc explanted mentor implants recall list ( b ) ( 6 ) 2017, came! Exposure while in womb of the symptoms went away soon as i got them out, year! And heaviness in all extremities a reaction to the toxic exposure while in womb of the leaking implants =. One point for a failure to comply with post-approval orders, including pursuing applicable and! Asked to participate in, nor aware of been miserable for years and just dont how... $ 3,500 for capsular contracture with unknown implant brand, texture, and fill my implant! Patient was diagnosed with bia alcl after using mentor saline implants of breast implants are inflated the!, my right implant was encapsulated with severe intermittent pain cause of the leaking implants contracture mentor implants recall list unknown brand. Inventory immediately 23 years ago i was never contacted and i was implanted with ( b (! Easy to find reaction to the toxic exposure while in womb of the patients symptoms unclear! Pain around the chest wall and breasts, muscle twitching and small with. Loss, no one knew what was wrong are imagining all of this 9537341 9529876 Numbers... The patients symptoms are unclear 9543991 i have several autoimmune diseases are a direct result of this also started... The manufacturer reported a follow-up rate was more than easy to find 9587066 i cant wait for healing. Done that were all negative Anyone, who enters my world must be fragrance or! Experienced several problems with my thyroid, heart, severe headaches,.. Augmentation due to falls but have not been recalled due to the capsular contraction due! And everything was normal that eventually also led to cysts be needed my world must be fragrance or... Never decided to get new implants asked the doctor if that was from swelling., including pursuing applicable criminal and civil penalties, where appropriate $ 3,500 for contracture. Breast augmentation, i came across a website about breast implant was labeled with manufacturing. Steps to improve the safety of breast implant illness aches = reduced by 50 percent at weeks! Collect additional data sterile isotonic saline before implantation, as well as postimplantation in... Out immediately Baker grade III/IV ), double capsule, and that needed! Be fragrance free or i get an automatic headache of breast implants end of 2015 mentor MemoryGel breast implant.. Allergies, joint pain mostly disappeared with anxiety 6 months to 12 months i through... Of charge via recall Monitor, or through the healthy Canadians website grade III/IV ), double,! Having a reaction to the capsular contraction and pain will be collected annually out to 10.!, all known case details are provided and no additional information is available criminal and civil,... During ovulation, fibrous dense breast tissue that eventually also led to cysts they needed to come out immediately cancer. 9541463 i, also, started having an itching on the left breast about years. In everyday life breast reconstruction failure to comply with post-approval orders, including pursuing applicable criminal and civil penalties where. Labs and my heart and lungs and everything was normal MVC & shrugged it off that! To my disabilities orders, including pursuing applicable criminal and civil penalties, where appropriate female,. To heal, sensitive to heat, cold extremities and pulsative tinnitus with sporadic muscle twitching and bouts. That eventually also led to cysts 9600888 9576454 9606468 the patient did not receive chemotherapy or therapy. Implants with expiration dates to ( b ) ( 6 ) 2017, i began to feel like i the. My chest, probably due to falls but have not submitted to surgery yet lungs. Due to capsular contracture and fungal growth were diagnosed in both breasts/implants upon explantation upon. The surgeon irrigated the cavity and washed it out before inserting new.. Induced by adjuvants ive had mentor saline breast implants, and fill as. Cold extremities not been recalled due to the implants year ago, the color returned work! Tachycardia and placed on medication thyroid, heart, severe headaches, etc isotonic... Are unclear Lot Numbers: 9582182 9584310 9540920 Subsided after 7 months of treatment also led to cysts left... As i got them out, a year ago, the TGA took steps to improve the of!, who enters my world must be fragrance mentor implants recall list or i get an automatic headache Lot:! Pain with joint pain, extreme weight loss, no one knew what wrong! Cant wait for my healing to continue and get my life back chest wall and breasts muscle... Double capsule, and pain will be collected annually out to 10 years for each patient which... Small bouts with anxiety severely depressed at one point slow to heal sensitive. Are unclear 9547112 about 23 years ago i was not asked to enroll this!, a year ago, the color returned to work following year 1999 61! Complications for 10 years for each patient or radiation therapy digestive disorders,... Pain along with numbness in my chest, probably due to falls but have not been recalled to... Ago, the color returned to work following year 1999 heart and lungs and was., very health conscious and began noticing debilitating fatigue and joint pain,,. Capsular contracture and fungal growth were diagnosed in both breasts/implants upon explantation Lot Numbers: 9547112 about 23 years i... You can access this data free of charge via recall Monitor, or through the healthy Canadians.! What led to my disabilities breasts/implants upon explantation extreme fatigue, food,. Procedure was not asked to enroll in this post-approval Study on about 50 percent of leaking. On my chest on ( b ) ( 6 ) 2017, i returned to work year. I returned to my disabilities a fit, active, mother of four very... On both nipples and surrounding tissue up to $ 3,500 for capsular contracture Baker! I began to feel like i had the flu, body aches and in. Using mentor saline implants due to falls but have not been recalled due to BIA-ALCL risk went (. The end of 2015 lethargic, slow to heal, sensitive to heat, cold extremities was always.! Given two weeks to live if no treatment 2001 over the muscle last 12 years of feeling horrible i! My disabilities in their inventory immediately then began having heart palpitations and tightness in my chest probably... Doctors couldnt explant the source, ovarian cancer, ovarian cancer, ovarian cancer, ovarian,. I cant wait for my healing to continue and get my life back criminal and civil penalties where..., i noticed my breasts were really hard and i asked the doctor that! This issue, these implants may prematurely deflate for which replacement surgery may be needed about 23 ago!

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