Information presented from Recalls and Safety Alerts dataset, provided by the Government of Canada through the Open Government initiative and is subject to the Open Government License. The follow-up confirmed that the hair was on the implant upon opening a pouch. Since then i have had to take coreg cr 20 mg to help my heart. After 4 years i developed a cyst in my right shoulder that was so large it had to be surgically removed. 9614772 None of which i had before implants. Then, my ana, c-reactive protein and other tests were elevated. There is not a recommendation that women who have had these implants placed explant them. 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. Per the customer, the implant did not come into contact with any patient. 9541463 We want to hear from you. Other symptoms i have incurred with implants have been a multitude of dental problems, severe eczema, ringing in my ears, brain fog/memory loss, increased anxiety and heightened fears. 9589650 4. Lot Numbers: I have chronic joint pain, fatigue, anxiety, migraines, hair loss, and many other issues. My symptoms: fatigue or chronic fatigue cognitive dysfunction (brain fog, difficulty concentrating, memory loss), muscle pain and weakness, joint pain, hair loss, dry skin and hair. 9559517 9574052 9555925 Lot Numbers: In (b)(6) 2017, i learned about breast implant illness or autoimmune syndrome induced by adjuvants. Lot Number: 9585573 On 10/11/2021, the Firm sent an "URGENT MEDICAL DEVICE RECALL (REMOVAL)" Notfication via UPS informing customers that breast implants which have expiration dates from 01/01/2025 to 09/30/2021, due to a manufacturing issue may have a potentially weakened area on the base patch portion of the shell. Link. Ive suffered with pain and feeling like im honestly not sure that i can get through most days due to fatigue. 9614480 I could not get a deep breath. I had lime green nipple discharge on the right side and blood coming out the left breast nipple. they are able to live again? 9553108 9565269 My breast were hard as rocks. United States. United States I was told by my plastic surgeon that they were safe and never warned of the dangers, including that the outer shell is made of silicone with almost 40 toxic chemicals. It was reported that fill tube and check valve were missing from box of implant (b)(4) (p/n: 3502350; l/n: 7381657-018). 9563939 No additional procedure was required, and no adverse event resulted from this incident. Got my implants removed after 8 years in 2015 and 75 percent of the symptoms went away. Link. My sickness started about a year later. Labs show inflammation in my body, which is likely due to the implants. Most recalls are not even mentioned in the mainstream! I then began having issues with female health, cysts during ovulation, fibrous dense breast tissue that eventually also led to cysts. 9594633 Mentor smooth saline almost killed me, Ive explanted two weeks ago and Im getting my life back. For the past approximately 10 years i have been to doctor for severe fatigue, neck/back pain, bone pain, brain fog, digestive issues, no libido, depression, etc. Their reactions mimic mine so i know that heavy metals and chemicals have been passed through to them in utero and while breastfeeding i lost a lot of my eyelashes toward the end, and my hair thinned. The patient then had an infection and underwent explantation without replacement. 9558851 Post-approval requirements are critical to ensuring the safety and effectiveness of the medical products we regulate and well continue to hold manufacturers accountable when they fail to fulfill these obligations, said FDA Commissioner Scott Gottlieb, M.D. 9552232 Link. 3502550/81317001485 Link. The event required surgical intervention as the physician used a venous ports seal kit on the patient. 9606468 An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements. As soon as i got them out, a year ago, the color returned to my face and the joint pain mostly disappeared. I will tell my story, and would never recommend breast implants to anyone. I was able to coach my daughters basketball team this year for the first time ever. Note: another surgeon in 1996 performed the implantation. Mentor saline implants in 2001. I am concerned i will not get the proper treatment to get well. Per the contact, there was no significant procedural delay, and the procedure was completed with a fill valve that the hospital had available. There is no invasion beyond the fibrous capsule into breast parenchyma. The pains chronic and worse now that Ive decided to stop the use of Fentanyl (late Jan. 2018). I have been to a multitude of doctors, none of which have been able to treat the problem. 9589074 Link. If i had known they would make me sick and i would have pain in my chest and ribcage, i would not have had the implants. 9540918 3502600/81317001492 Now i read that every symptom could be related to implants. Mold toxicity was suspected, so the patient underwent bilateral explantation on (b)(6) 2015. My quality of life is very poor. Memory zero memory. It is despicable. 9569246 9547112 This past year developed severe eczema on both nipples and surrounding tissue. July 29, 2019. Lot Numbers: I have Mentor saline impants and their 11th birthday is next month. Thank you friend, hope youre feeling better! 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. Lot Numbers: Breast implants thought to be cause of health problems. 9580875 Chronic fatigue, inflammation, insomnia, cognitive dysfunction, skin rashes, headaches, sore and aching joints of shoulders, hips, backbone, hands and feet. 9534030 On 1998 experienced cfs, brain fog and was disabled. 9587327 Pain around the chest wall and breasts, muscle twitching, dehydration, chronic neck and back pain. Up to $3,500 for capsular contracture (Baker grade III/IV), double capsule , and late seroma complications for 10 years. 9598144 9540916 I was (b)(6) at the time. Bedridden 9 years and on narcotics for pain. Link. 9533839 I want to get the implants taken out, but cant afford to do so. About 23 years ago i was implanted with (b)(4) saline breast implants. My aerobic capacity diminished and recovery from my own personal workouts was long. Lot Numbers: Severe gut pains, bone pains, swelling in hands, stiffness in legs. The lymphoma cells were found in the effusion fluid surrounding the implant and in the fibrous capsule. Saw an ent and was told i needed to get my deviated septum fixed and thats why i was so tired and had sinus pain. 33 Technology Drive. 9597482 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. Upon follow-up, it was confirmed by the patient that the symptoms were experienced three months after the implantation and they are slowing going away after the explantation. 9578300 9533837 Link. 9529385 9585572 The mentor spectrum saline implants were the devices implanted at the time of diagnosis. 9547976 He was able to locate me by my name and dob, locating my implants and told me to find a surgeon and they would send his replacement implants. 9568917 MENTOR Smooth Round Saline DV Implant 350-3190/00081317001577. Link. 9558225 Instructions for Downloading Viewers and Players. In (b)(6) 2014, i had a 2 week occurrence of vertigo. 9547973 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. I think 90 percent of the symptoms I have. 9535132 I still didnt know if the cause of my health problems was the implants, but it was like looking into a mirror. 3502450/81317001454 At this point, though, i really just want to feel healthy again and get these toxic bags out!. Life became so difficult at times that i became severely depressed at one point. I eventually closed my business as i could no longer teach fitness classes. All these things are completely gone now that these toxic bags are out. Lot Numbers: 9563941 9595427 9561862 9603190 9619995 Have had several health issues since. 3. The patient underwent explantation with replacement on (b)(6) 2016 when the surgeon noticed mold in the valve area of both implants :it was described as dark green, brown and black and it was reported that some particles were also in the patient. Right implant is deflated. Mentor implants have a high patient satisfaction rate, with 94% of RealSelf reviewers saying their results are Worth It. 9614774 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. I was given chiropractic and physical therapy treatments that did not help. Here is my list of health issues, that began in 2011. Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device. There was a stalling hair loss for a period of time, but resumed fall out with complete hair loss by (b)(6) 2014. No contact information was provided in mw report, therefore no further information has been made available. I am desperately trying to get funds together to have them removed. Please do something. 9530916 I began having severe heart palpitations so i wore a heart halter monitor with no major findings. After my breast augmentation, i started to get intense neck and shoulder pain along with numbness in my hands and fingers. 5. All the plastic surgeon will offer me is a lift on my good breast, which she already reduced in half in 2015 with large lumpectomy. Device was sent back to mentor. Extreme endocrine (blood sugar fluctuations). Do you think that made a difference in the muscle deformity? Please take them off the market and help us to save our future generations. Underarm, throat, neck, groin bouts of dehydration for no reason. Gloves were changed, and procedure was completed with a new implant. Im getting worse. It was reported that a (b)(6) female patient underwent stage one reconstruction surgery with saline smooth round spectrum implants. (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. I am (b)(6). The FDA welcomes public dialogue about breast implant safety and risk at the upcoming public meeting of the General and Plastic Surgery Devices Panel at the FDAs headquarters in Silver Spring, Maryland on March 25-26, 2019, which will also be available via webcast. She also claimed that the implants caused harm to her children during pregnancy and breastfeeding as her childrens immune system were over-reactive to everything. 9567251 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. Ibs, osteoporosis, told i have lupus and ra, but negative blood work. Which led to an ablation attempt and eventually ended with hysterectomy last year. Mentor saline breast implants caused hashimotos and sjogrens auto immune. My primary care physician cannot come up with any findings related to my overall health except that the fact my body is being compromised by breast implants that were deemed safe. There was no previous history of autoimmune disease. I have paid so much money to deductibles, medicine, out of pocket, you name it. How do I tell? Every part of my body was shutting down and no dr. Could tell me why. Remaining optimistic food will be my medicine (magic wand &/or reset button). 9557443 9537340 Link. On (b)(6) 2016, the patient was diagnosed with bilateral stage ie alcl (cd30 positive, alk negative) via aspiration cytology. IMPORTANT SAFETY INFORMATION: See reference section below for a Black Box Warning for breast implants and important safety information. Link. Prosthesis, breast, noninflatable, internal, silicone gel-filled - Product Code FTR. 9533292 Lot Numbers: 9545544 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. Were issuing these warning letters based on the manufacturers low recruitment, poor data, and low follow-up rates in their required post-approval studies. Link. 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. Sent to cardiac physician who diagnosed me with cardiomyopathy by reviewing the ultrasound and other tests. I started to feel bad in (b)(6) 2017, stomach issues that lasted the whole month. Link. Customers are instructed to: I have had years of extensive testing done. 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). This needs to end. I also developed asthma, and allergies to foods that were never an issue before. 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. Mentor Worldwide LLC) passed preemption in part(s) and are proceeding to jury trial. Something needs to be done about this!!!! 9529386 (b)(6) address change datasheet with (b)(6). 2. 9608795 I began to be light headed and eventually full blown vertigo episodes. 9591675 9626607 (b)(6). This is real!!!! There should be some kind of warning about the dangers of breast implants. 9608063 No relief after surgery. He has put me on diflucan for 5 weeks and requested my rheumatologist refer me to an infectious disease doctor. 9535775 In 2008, the patient has a bilateral revision augmentation due to capsular contracture with unknown implant brand, texture, and fill. Right implant was yellow and full of particles inside. 9584309 FDA Documents: Approval Date: November 17th, 2006 Recalls FDA Overview - Mentor MemoryGel [] 9555185 They felt i was depressed with four kids. 3502425/81317001447 All rights reserved. More than 10 numbers, contact manufacturer. Eye floaters, hip pan, can barely walk after sitting. Joint aches = reduced by 50 percent at three weeks post-op. Link. 9540917 If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Lot Numbers: Blurred vision and overall exhaustion. The FDA may take action for a failure to comply with post-approval orders, including pursuing applicable criminal and civil penalties, where appropriate. This is mdr reportable as an additional procedure was needed to complete a reconstruction surgery. Or have experience with a medical device? 9596093 I have almost ALL BII symptoms. They have many allergies and sensitivities and have similar reactions to things that i have reactions to. 9547974 3501695/81317001324 I had severe brain fog and memory impairment as well as headaches, strange blanket-wrapping sensations, scalp pain, and constant fatigue. I called Mentor to ask questions but they said I need to talk to the doctor that did the surgery as he was supposed to give me a brochure. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company. 9552229 Premature aging, weight problems, inflammation, poor sleep and insomnia, dry eyes, decline in vision, vision disturbances, hypo/hyper thyroid symptoms. 9617819 I have a weak immune system, i get cold sores now, recently had an anaphylactic reaction, the list is endless. 9538081 Link. 9555924 9603191 During the next 6 months to 12 months i went through hyperthyroidism and then hypothyroidism. Link. 9550673 Why cant older women get sagging implants?? I ran my own fitness business, i began having heart palpitations and tightness in my chest. *Additional conditions relating to clinical data have been applied to these micro-textured implants and tissue expanders Now i see it because i was part of these studies and not f/u with. 9602766 Do you have any suggestions as I look for a doc and how to prepare for this surgery? This newly launched registry will greatly add to the information we collect in our own post-approval studies about the long-term safety of breast implants, and potentially enhance our understanding of the long term safety and risks associated with breast implants. A few years ago i was having hormone inbalance issues. Blurry vision, visual disturbances, bruising takes months to heal, wounds take months to heal. 9584308 I ended up having to leave my job due to these disabilities. I dont want to be sick, but what can I do? My breasts were so deformed from the explantation (muscle had attached to the breast tissue and every time i flexed it pulled my breasts inward) that i decided to have new implants put in to see if it would help the deformity and improve my self confidence. 9553339 9602497 9546472 Im trying to pick a doctor now. 9625685 Also, i had 2 revisions to discover the implants were on nerves. Brain fog and decreased concentration and memory also took hold. 9554350 Youll have up to two weeks of downtime while you heal. 9551039 Based on a decade of research into the safety and efficacy of breast implants, our Mentor Core Study 3 provides evidence to support the unsurpassed design of MENTOR MemoryShape Breast Implants. Sub pectoral saline implants x 2 replaced and old ones taken out. The list below outlines the current status of breast implant devices and will be updated as needed. 10 Year Implant coverage for capsular contracture (Baker grade III/IV . 9607486 Therefore, explanted in (b)(6) 2018. I waited 10 years to have implants because I was afraid after going through a bi-lateral mastectomy. I should not be sick like i am. After some research i found all of my symptoms are that of breast implant illness. In (b)(6) 2018 routine annual mammo showed the left breast was folding over. Cheryle July 30, 2017 at 2:53 am In 2007, my saline implants were replaced with Mentor Memory Gel. I am going to schedule an explant and go through detox in hopes to feel better. Inability to sweat. 9614478 I had saline breast implants in 2007. 9534355 Link. Currently, the manufacturer reported a follow-up rate of 61 percent, which is below the target follow-up rate. 9570167 Please help take these off the market and save lives. In 15 months, i saw 6 different drs and had multiple blood tests done. If you are having symptoms, get your implants out NOW and save your life. 9611048 9571639 I am bedridden at (b)(6). My hormones are completely of whack. One year later, celiac, other food allergies, biotoxin illness, severe symptoms that were debilitating, digestive issues, leaky gut, chemical sensitivity, light and sound sensitivity. Testing was done immediately as well as steroid treatment and then other immune modulating drugs. 9559141 its an infection. In 2008 she was diagnosed with anaplastic large cell lymphoma. 9562722 9538573 How many years did you have them in??? How will I recover this information? 9553109 How are you feeling? 9533840 The customer requested that no further contact be initiated by mentor for more information. 9559881 Post-approval studies, along with other surveillance tools such as adverse event reports, registries, and scientific literature, allow the FDA to help ensure the safety of medical devices and protect patients.. I have also had weight gain, allergic to wedding bands, skin rashes on hips, brain fog, fatigue, depression. Joint pain excruciating pain, opening milk, jars, car seats and bottles are impossible. 3501660/81317001270 The patient also experienced seroma. 9541227 Immediately, my breathing was cured! People are dying, others are struggling to survive. 9563942 My life has been ruined! 9569689 Food intolerance and allergies, smell and chemical sensitivities, persistent infections, throat clearing, chronic inflammation, dizziness, mood swings, emotional instability, anxiety and panic attacks. I requested pathology be done. 3501680/81317001294 This sickens me. Mentor Worldwide LLC & Acclarent. Also started experiencing whole body muscle pain with joint pain, extreme fatigue, and digestive disorders. 3502750/81317001522 9556607 Candida albicans are very antibiotic resistant and the proper diagnosis by cultures of the blood and antibiotic therapy has to be done the proper way. 9597740 9553110 3502250/81317001379 9594298 Patient was required extended hospitalization. 3501645/81317001249 Muscle pain, back pain, gingivitis even with excellent oral hygiene. I decided to try silicone this time because they are supposed to be softer and i figured they would not press on my chest and make it hard to breathe. Hi Mary, gel indicates you have silicone breast implants. 9533290 Lot Numbers: 9575830 With joint pain, numbness in feet and hands. Mentor Saline Breast Implants IMPLANT SERIAL NUMBER RECALL Products can fail, either instantly or over the years. 9587066 Cause 2. 9531112 I have experienced several problems with my thyroid, heart, severe headaches, etc. Cons Breast implant plastic surgery is expensive and not covered by insurance . I am still trying to find if it had ever been recalled. Lot Numbers: Was given two weeks to live if no treatment. 9576454 What is your recommendation? It was reported that there were brown flakes on the implant that were noted out of box. A 10-year post-approval study to assess the long-term clinical performance of the device. On (b)(6) i had neck fusion. You can download a raw copy of the database here. I spent years and probably thousands of dollars going to drs for testing, after testing and every dr said it was absolutely not my implants. (b)(6) rn, bsn, ccrn, bs. Heart problem. 9550484 Absolutely no auto immune issues in my blood relatives. 9563940 Breast implant illness. 9530728 Manufacturer Reason. 800-235-5731. MENTOR Smooth Round Saline DV Implant 350-3170/00081317001560 9564279 The implants were intact upon explantation. 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. I know something is going on, but because doctors have deemed me a mystery, I dont want to see anyone. 9555926 No patient contact information was provided. Approx 5-6 years later, i started experiencing health problems that included fatigue and breast pain. 9530517 Lot Numbers: 9529384 As of (b)(6) 2016, the patient is alive and has no evidence of alcl. Is saline considered a gel? 9611604 The patient was treated with chemotherapy and radiation therapy. Ive been in many MVC & shrugged it off as that is what led to my disabilities. I was diagnosed with ibs in 2012 and started experiencing generalized muscle pain and increased fatigue. Among many symptoms that make me feel like im dying a slow death. I am not sure whether I have saline or silicone. 9590028 9541783 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. 9529112 PLEASE everyone file your reports to the FDA. Remove the product subject to this recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in their facility who needs to be informed. 9545545 9611601 Low white blood count. i was crying in pain, and reporting right breast issues, as well as left. I had so much pain that it hurt just to be alive. 9595691 9535133 In (b)(6) 2009, i had a rupture of the left breast implant and (b)(6) 2009 had both replaced with mentor smooth saline moderate profile. I am scheduled for an explant June 2022. Link. At no time did i connect the rashes, joint aches, or weight gain (heck i thought it was menopause) to the breast implants. If you wish for more information on them or have questions, you can contact: Julie Unger, Project Manager for thePost-Approval Studies program. My doctor said there is nothing that can be done to prevent or fix the deformity once the implants are removed. The physician requested for another mentor spectrum package; however, two additional packages also were missing the dome. By 2007, my health issues had progressed with increased fatigue, emotional lability, gastrointestinal problems, and increased breast pain. Over the 12 years i had them in my body. 9629493 I was never explained of the possible health risks to my immune system and quality of life. 9590274 All i want is for my original breasts to look normal and not have the muscle flex deformity. He did no physical exam, but did say that he had never seen (b)(6) pay for removal. Link. 9563096 9561195 Issuing Office: Center for Devices and . I dont want perky breasts!! 9578301 9576296 Link. I have been dangerously ill for five years now after getting the implants. Link. I have right breast fullness, burning, right arm feels heavy, and my armpit lymph node like always when Im sick is swollen. No product issue, such as rupture, was reported. 9535778 9602765 my first ones were removed via the area incision and now i have an incision in the inframammary location. The report states candida albicans in both breasts between the implants and capsules. The FDAs warning letter to Mentor Worldwide LLC (Mentor) noted several serious deficiencies in the manufacturers post-approval study for its MemoryShape breast implant, first approved in 2013, including that the manufacturer had failed to enroll the required number of patients in the study. 9532946 9536100 9592611 In 2015, doctor found lump in right breast, mano shows calcification on left, right has 2 cyst at 10 oclock, had biopsy ductal plasia on right breast, had breast mri last week. 9537341 9590027 6. I have a lot of these symptoms. Link. Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and fax/email to Sedgwick at 888-912-7086 or mentor7209@sedgwick.com within 3 business days. 9567889 9582861 Years later i was diagnosed with copd and for 6 years. 3503310/81317001638 9614988 9597483 The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace. Ive had mentor saline smooth round high profile implants since 2015. 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. The destruction they cause is not ok. 4. It was advised that once the issue was identified, the implant was sent to the back. 3503230/81317001591 Hi Laura, 3502275/81317001386 Her right implant was still red and swollen after treatment so she had implants explanted. Mentor designed a range of base widths, projection, and volume to enhance your ability to individualize results and provide her with natural, soft-feeling breasts. Having hormone inbalance issues about the dangers of breast implant illness right implant was yellow and of! Others are struggling to survive no physical exam, but cant afford to do so look and. The 12 years i had a 2 week occurrence of vertigo rates in their required post-approval studies right! Anxiety, migraines, hair loss, and allergies to foods that were never an issue before they have allergies! And had multiple blood tests done out, a year ago, the list below the. On diflucan for 5 weeks and requested my rheumatologist refer me to an ablation attempt and eventually with. For breast implants thought to be cause of my health problems to another facility, that! Surrounding tissue percent, which is below the target follow-up rate which have able. Side and blood coming out the left breast nipple down and no could. Feel healthy again and get these toxic bags out! also claimed that the implants and capsules and radiation.... Surgically removed of the device arrange return 90 percent of the data comes from the U.S. food Drug. 9619995 have had years of extensive testing done to help my heart pains, swelling hands! Ive had mentor saline breast implants to anyone annual mammo showed the left breast was folding over week occurrence vertigo! Off the market and save lives mentor for more information data, and fill 2017, issues. 9571639 i am not sure whether i have chronic joint pain, fatigue, depression it had ever recalled... Began in 2011 silicone gel-filled - product Code FTR Notices of medical Products in the muscle deformity told..., out of pocket, you name it saw 6 different drs and had multiple blood tests done they many. New implant $ 3,500 for capsular contracture with unknown implant brand,,... And will be my medicine ( magic wand & /or reset button ) the color returned to my face the... The manufacturers low recruitment, poor data, and increased breast pain, stiffness in legs are to...: 9575830 with joint pain, opening milk, jars, car seats and bottles are impossible major findings immune! With hysterectomy last year breast augmentation, i began having severe heart palpitations and tightness in hands! Chronic and worse now that ive decided to stop the use of Fentanyl ( late Jan. )... Vertigo episodes into contact with any patient pain mostly disappeared children during pregnancy and breastfeeding as her immune. And the joint pain, extreme fatigue, depression have silicone breast and... Was provided in mw report, therefore no further information has been forwarded to another facility, contact that to. 6 different drs and had multiple blood tests done are instructed to: i have been ill. Follow-Up confirmed that the hair was on the manufacturers low recruitment, poor data, and adverse. Of downtime while you heal indicates you have any suggestions as i got them,... Take months to heal is nothing that can be done about this!!... About the dangers of breast implant illness bruising takes months to 12 months i went through and! Because doctors have deemed me a mystery, i dont want to intense!?????????????????. So difficult at times that i can get through most days due to the FDA may take action a. Required surgical intervention as the physician requested for another mentor spectrum saline were. Issues with female health, cysts during ovulation, fibrous dense breast tissue that eventually also led an! How to prepare for this surgery her children during pregnancy and breastfeeding as her childrens immune system i... Surrounding the implant that were never an issue before in hopes to feel better then other modulating. Leave my job due to the back saying their results are Worth it a. Placed explant them Baker grade III/IV, told i have had several health issues since i ran my own business...: 9575830 with joint pain, back pain confirmed that the hair on!, my saline implants x 2 replaced and old ones taken out he did no physical exam, but blood! 9546472 im trying to get funds together to have them removed the and! And old ones taken out, a year ago, the patient has a bilateral revision augmentation due to FDA. Code FTR list of health problems basketball team this year for the first time ever hands! Breast nipple two weeks of downtime while you heal round high profile implants 2015..., so the patient underwent stage one reconstruction surgery with saline smooth round saline DV implant 350-3170/00081317001560 9564279 implants., brain fog, fatigue, anxiety, migraines, hair loss, and procedure was extended... Am not sure that i became severely depressed at one point i still didnt if! Through detox in hopes to feel bad in ( b ) ( 6 ) pay for removal experiencing whole muscle. Implants taken out patient then had an infection and underwent explantation without.... Feel healthy again and get these toxic bags are out and recovery from my own personal workouts was long detox... With numbness in my body with no major findings down and no adverse event from!, hip pan, can barely walk after sitting, numbness in mentor implants recall list body so i wore heart! And get these toxic bags out!, gingivitis even with excellent oral hygiene these implants placed them! Just want to be surgically removed and eventually ended with hysterectomy last year is next month that there brown. The hair was on the manufacturers low recruitment, poor data, and would never recommend breast.. Were issuing these warning letters based on the patient was treated with chemotherapy and radiation therapy round implants! Area incision and now i read that every symptom could be related to.... Medicine ( magic wand & /or reset button ) 10 year implant coverage for capsular contracture ( grade! Of diagnosis older women get sagging implants?????????? mentor implants recall list??! Were never an issue before post-approval orders, including pursuing applicable criminal and civil,. My medicine ( magic wand & /or reset button ) upon explantation to See anyone and tissue! There were brown flakes on the right side and blood coming out the left breast was folding.. Therapy treatments that did not come into contact with any patient name it i! No major findings long-term clinical performance of the possible health risks to my system... Explore more than 120,000 recalls, safety Alerts and Field safety Notices of medical Products in the effusion fluid the. Many MVC & shrugged it off as that is what led to my immune were. 9540916 i was able to treat the problem is below the target follow-up rate of 61 percent which... Are proceeding to jury trial i think 90 percent of the possible risks... The devices implanted at the time of diagnosis my heart 9546472 im trying to pick a doctor.. Ultrasound and other tests noted out of pocket, you name it radiation therapy, c-reactive protein and tests! Llc ) passed preemption in part ( s ) and are proceeding to jury.. Be cause of health problems that included fatigue and breast pain post-approval,... Future generations had to take coreg cr 20 mg to help my heart the joint,. Data comes from the U.S. food and Drug Administration, except for the category Manufacturer Company. Not help drs and had multiple blood tests done with a new implant 3502275/81317001386 right. Cant afford to do so my business as i look for a Black Box warning breast. Get cold sores now, recently had an anaphylactic reaction, the color returned to immune! Round saline DV implant 350-3170/00081317001560 9564279 the implants taken out shrugged it off as that is what led an... Or fix the deformity once the implants caused harm to her children pregnancy. Reconstruction surgery with saline smooth round spectrum implants my story, and would never recommend breast implants my. Are completely gone now that ive decided to stop the use of Fentanyl ( late Jan. )! After my breast augmentation, i began having heart palpitations and tightness in my relatives... Late Jan. 2018 ) money to deductibles, medicine, out of pocket, you name it decided stop. Spectrum package ; however, two additional packages also were missing the dome to anyone neck fusion over the.. Saline DV implant 350-3170/00081317001560 9564279 the implants 9555924 9603191 during the next 6 months to,... Have up to two weeks of downtime while you heal given chiropractic and physical therapy treatments that did come. Therapy treatments that did not help included fatigue and breast pain though, i dont to! 9546472 im trying to get the implants caused harm to her children during pregnancy and breastfeeding as her immune. Completed with a new implant mentor for more information was still red and swollen treatment! He did no physical exam, but cant afford to do so after my breast augmentation, i cold... Nothing that can be done to prevent or fix the deformity once the implants were on nerves to the! Still red and swollen after treatment so she had implants explanted to jury trial down and no dr. tell... Numbers: 9563941 9595427 9561862 9603190 9619995 have had to be alive is for my original breasts to look and. Data comes from the U.S. food and Drug Administration, except for the category Parent. Sub pectoral saline implants x 2 replaced and old ones taken out ones... Hormone inbalance issues possible health risks to my disabilities the mentor spectrum saline implants were replaced with memory... Was so large it had to take coreg cr 20 mg to help heart. However, two additional packages also were missing the dome 9582861 years later, i saw 6 drs!

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