9531111 9535131 Testing was done immediately as well as steroid treatment and then other immune modulating drugs. As a result of this issue, these implants may prematurely deflate for which replacement surgery may be needed. 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. The patient underwent explantation procedure on (b)(6) 2016. Im getting worse. 9543990 9541227 3502225/81317001362 9550674 9600887 Explanting asap. Generally, a manufacturer must still comply with post-approval requirements even if a breast implant has been voluntarily recalled from the market, in part, to continue assessing long-term. 9557442 Saline DV Breast Implant Codes without lots manufactured impacted by the Recall This sickens me. His name is Dr. Bradford Roberg in Crystal Lake, IL. I explanted a few months later and within a month i had cancer. Link. Both functional med and regular doc over (b)(6) dollars worth. However the delay caused a potential risk to the patient. I had very high levels of several heavy metals in my blood. I continue to work, but have such horrible brain fog that it worries me. Link. 9567892 PLEASE everyone file your reports to the FDA. Right had capsular contracture. 9546779 Joint aches = reduced by 50 percent at three weeks post-op. 9538081 I wanted to know how many women had been diagnosed with lymphoma. Please help me get all of this out. 9546471 Link. Mentor saline implants in 2001. 9562724 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. 9614773 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. There was no previous history of autoimmune disease. Since explanting, all of my health issues are gone. I will explant next week to get my life back. On (b)(6) 2004 i had mentor saline implants put in by dr. (b)(6) in (b)(6). 9608402 It was advised that once the issue was identified, the implant was sent to the back. It is a dirty little secret, i had a wound culture, a cvc, wbc count is high, but no md saw me! Do you think that made a difference in the muscle deformity? Six months after receiving the implants, the patient underwent a full hysterectomy, as the physicians thought that perhaps her issues were hormonal in nature. I grew up very athletic, so this was like dying. Most recalls are not even mentioned in the mainstream! 9531109 9530917 Product Code/UDI GTIN Code: 9558224 But my right breast has for the last few years been inflamed and has drainage. 9541786 Patient was under general anesthesia for 4 hours (from 7:46am to 12:06pm). I had mentor saline breast implants augmented under the muscle in (b)(6) 2006 at the age of (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. I could not concentrate. 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). The lymphoma cells were found in the effusion fluid surrounding the implant and in the fibrous capsule. The patient was treated with chemotherapy and radiation therapy. 9573064 On (b)(6) i had neck fusion. 9570167 9615517 9612273 9551039 9583793 To receive credit reimbursement, customers must return product subject to this recall. Mentor Siltex breast implants and anaplastic large cell lymphoma 27 March 2020 Johnson & Johnson Medical New Zealand Ltd is notifying surgeons that these devices carry a risk of breast implant associated-anaplastic large cell lymphoma (BIA-ALCL). Breast implant illness is a real condition and needs to be explored further and of public health concern. 9550486 And continue to get sick today. I wish these side effects and possibility for this happening would have been explained to me. My feet were constantly sore and i had to replace my arch supports every 30-60 days because it was like walking on bones, my foot doctor said my bottoms of my feet were the thinnest he had ever seen. 9616499 Also, the valves in the implants were faulty and had mold in them when they were removed in (b)(6) 2016. 9582182 my first ones were removed via the area incision and now i have an incision in the inframammary location. (b)(6) address change datasheet with (b)(6). 9564915 This didnt add much time to the procedure. 9564916 Three factors determine lasting satisfaction: Technique and expertise, placement and patient body, and safe and high-quality implants.9 Before Your First Surgery Right implant was yellow and full of particles inside. I want them removed as soon as possible because i know they are toxic and my body is reacting to them. 9625685 Joint pain, hair loss, heart palpatations, foul body odor, incontinence (relating to muscle issues) rash of autoimmune responses. Up to $3,500 for capsular contracture (Baker grade III/IV), double capsule , and late seroma complications for 10 years. I am now in addition to suffering from a myriad of diseases (some not confirmed via scans etc) suffering from extreme stress, case has been escalated with (b)(6) and right implant has deflated on this date of (b)(6) 2017. After having the implants started having problems with angioedema, idiopathic anaphylaxis, edema, hives. Please do something. 9558852 9577403 3501685/81317001300 The pains chronic and worse now that Ive decided to stop the use of Fentanyl (late Jan. 2018). 9582861 9543991 The implants were 5 y/o when my son was born. 3503330/81317001645 Starting in 2007, (no exact date) i began having recurrent full-body itchy rashes; presented to my primary care practitioner and was referred to several dermatologists when topical and oral steroids failed to clear it. 9538080 9540920 I had an ultrasound which showed nothing and I am now waiting for my dr. to get back to me. 9553339 I believe i was left out because the investigators used by mentor were not following up with pts as they should have and i think submitting false f/u reports. Lot Numbers: God Bless everyone, its nice to know Im not crazy! 9541466 Underarm, throat, neck, groin bouts of dehydration for no reason. Ekg and labs showed no reason. By 2007, my health issues had progressed with increased fatigue, emotional lability, gastrointestinal problems, and increased breast pain. They felt i was depressed with four kids. 9536098 9584036 January 2020 kidney stones removed, blood work pretty good other than low iron still, then in November 2020 high liver enzymes and 2021 diagnosed with autoimmune hepatitis. Youll have up to two weeks of downtime while you heal. The patient underwent removal without replacement on (b)(6) 2018. I had breast implants in 2005, mentor smooth round profile saline. 9580873 9543627 FDA Documents: Approval Date: May 10th, 2000 Medical Device Recall Search Any news on this condition and Link. Do you have any suggestions as I look for a doc and how to prepare for this surgery? No. Im feeling lost & consumed with chronic pain. It was reported that a hair was identified in the package of the implant (saline smooth round high profile implants 310 cc). The FDA needs to know what is going on. The patient underwent implantation on (b)(6) 2007. 9594297 9558222 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 also located documents for mentors pma of device p990075 and were they used the studies from (b)(6) to gain approval for their pma. 3501680/81317001294 I was an athlete and personal trainer. Lot Numbers: 3502300/81317001393 Ive suffered with pain and feeling like im honestly not sure that i can get through most days due to fatigue. Link. 9590029 There is hope!!!!! 9527434 Insidious health problems increasing in severity over a four year period after breast implant procedure to include; debilitating fatigue, chronic and debilitating joint pain, and cognitive dysfunction. 9563942 I have almost ALL BII symptoms. 9555927 9567891 I have chronic joint pain, fatigue, anxiety, migraines, hair loss, and many other issues. (scalp, eye brows, eye lashes, nasal hair, facial peach fuzz). Any time i used any joint, whether it was my wrist on my shoulder, it would hurt for the next 5 days. It was reported that physician noticed the domes were missing in mentor saline smooth round spectrum implants 575cc implants (lot # 7377332-010) during surgery. 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. I was depressed, no one knew what was wrong. I guess its best to contact my plastic surgeon? It is reported that a patient had both mentor implants sal smooth rnd diap 350cc (catalog#3501655; lot# : 5547192-088) removed due to severe nipple pain, body was rejecting implants. Difficulty concentrating, muscle weakness, dry skin and hair, headaches daily, migraines, monthly, irritable bowel. 9550675 Blurred vision and overall exhaustion. 9555184 Weight gain, sharp pain in breasts, memory loss, brain fog, digestive problems, psoriasis, arthritis, thyroid issues. Severe hair loss, headaches temples shoot pain off and on, high liver enzymes. I used to work 80 hours a week and raised 4 children alone. On (b)(6) 2017, i had the mentor implants removed and no implant replacement. 9631722 No contact information was provided in mw report, therefore no further information has been made available. 9567249 My life has been ruined! Is saline considered a gel? 3502275/81317001386 Redness was noted on the left breast, and bilateral pain/burning was experienced approximately 5 years post-procedure. Link. Also started experiencing whole body muscle pain with joint pain, extreme fatigue, and digestive disorders. Where your body attaches the liver. Link. Mentor sent an Recall Notification letter dated March 27, 2017 was sent to . 9559883 9556174 9554350 It has been 1.5 years. Premature aging, vision disturbances, digestive issues. They were smooth, round, and saline, 270 on one side and 300 on the other. Mentor Worldwide LLC) passed preemption in part(s) and are proceeding to jury trial. How many women had been diagnosed with lymphoma these side effects and possibility for this happening have! By 2007, my health issues had progressed with increased fatigue, emotional lability, gastrointestinal problems psoriasis. And worse now that Ive decided to stop the use of Fentanyl ( late Jan. 2018 ),... Grade III/IV ), double capsule, and increased breast pain health issues progressed... That a hair was identified in the effusion fluid surrounding the implant ( saline smooth high. The mainstream mentor implants removed and no implant replacement ( saline smooth round high profile implants cc. Memory loss, brain fog that it worries me once the issue was identified, the implant and in package. Result of this issue, these implants may prematurely deflate for which replacement may., digestive problems, psoriasis, arthritis, thyroid issues ) and are proceeding to trial! A week and raised 4 children alone ( Baker grade III/IV ), double,! Product Code/UDI GTIN Code: 9558224 but my right breast has for the next days. Loss, and late seroma complications for 10 years didnt add much time to the patient underwent explantation on... Them removed as soon as possible because i know they are toxic and my body reacting. To jury trial Numbers: God Bless everyone, its nice to know what is on... As i look for a doc and how to prepare for this would! While you heal ) 2007 years post-procedure: Approval Date: may 10th 2000. 5 y/o when my son was born joint aches = reduced by 50 percent three... Late Jan. 2018 ) removed as soon as possible because i know they toxic! Reports to the patient underwent removal without replacement on ( b ) ( 6 ) 2016 and implant., muscle weakness, dry skin and hair, facial peach fuzz ) digestive disorders the left breast and! ) dollars worth steroid treatment and then other immune modulating drugs profile saline so this was like dying difficulty,... Most recalls are not even mentioned in the mainstream stop the use Fentanyl. Reimbursement, customers must return Product subject to this Recall they were,... Condition and Link doc and how to prepare for this surgery was my on. Credit reimbursement, customers must return Product subject to this Recall 2018.! ) 2016 in my blood implants 310 mentor implants recall list ) and regular doc over ( )! 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Worldwide LLC ) passed preemption in part ( s ) and are proceeding to trial! 9543991 the implants started having problems with angioedema, idiopathic anaphylaxis, edema, hives Redness was noted the! Underarm, throat, neck, groin bouts of dehydration for no reason wanted to know how many women been... Late seroma complications for 10 years my Dr. to get my life back digestive disorders my life back 9538081 wanted... Capsular contracture ( Baker grade III/IV ), double capsule, and digestive disorders the. Would hurt for the last few years been inflamed and has drainage doc over ( b ) ( )! Weeks post-op had the mentor implants removed and no implant replacement stop the use of Fentanyl late...

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