I have been holding off getting the implant I need because I a 72 and I want the same profile sagging that I have in my other breast. This is real!!!! I scheduled an explant for 12/02/20. Over the 12 years i had them in my body. On (b)(6) 2016, the patient was diagnosed with bilateral stage ie alcl (cd30 positive, alk negative) via aspiration cytology. 9555186 9563940 Lot Numbers: 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. Lot Numbers: 9551037 Approximately two weeks after the procedure, the patient began to experience a number of symptoms, including extreme anxiety, numbness, tingling, joint pain, brain fog, memory loss, confusion, vision problems, food allergies, difficulty walking, breathing issues, muscle atrophy and hormonal issues. 9600888 9597741 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. 9611048 I have been in the er at least 5 times due to headaches, heart palpitations, anxiety, etc. I explanted a few months later and within a month i had cancer. A lower risk of complication is rupture. I believe the reason for all of my autoimmune diseases are a direct result of breast implants, recall all. 3503460/81317001676 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). We expect these manufacturers to meet the pre-specified study requirements in order to ensure the collection of long-term data that can be used to inform long-term patient safety. Toward the end of the 12 years, i was not able to be on my feet for long and not able to walk or run, other than grocery shopping and the duties of being a mom. Ive had tests done and never anything found. 3502275/81317001386 Bruising on body, brain fog, joint muscle chronic pain, body swollen, use walker or cane. At any rate, i explanted (b)(6) 2017. 18yrs with Saline Mentor. Mechanical testing (i.e., fatigue rupture and shelf-life) to collect additional data. Link. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. 3502750/81317001522 I had my explant bilateral capsulectomy 01-14-2020 and am grateful to #1 GOD and secondly to all the medical community including my dentist that recommended a TMJ Pain Specialist who made me realize I was taking way too many prescriptions over a decade and some were opiates. The patient was treated with chemotherapy and radiation therapy. In (b)(6) 2015, the patient began developing capsular contracture in the left breast and in (b)(6) 2015, began developing capsular contracture in the right breast. 9580414 9585573 I recently fell on (b)(6) 2017 saw a md next day. 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. I want them removed as soon as possible because i know they are toxic and my body is reacting to them. 9594635 Or have experience with a medical device? 9580873 Follow instructions in the letter and immediately return any inventory of MENTOR Smooth Round Saline DV Breast Implants with expiration dates ranging from 01/01/2025 to 09/30/2025 subject to this recall to Sedgwick. 9588332 9541785 9612275 FDA Determined. Mold toxicity was suspected, so the patient underwent bilateral explantation on (b)(6) 2015. 9537340 The years following, i had fainting episodes, seizures and all my doctors couldnt explant the source. Link. Lot Numbers: Report physical symptoms of severe back, breast, thoracic rib pain, neck pain, difficulty sleeping and i told him that i thought left implant had a slow leak. 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. I have my receipt, and physician doctor appointment pre-op information, warranty sheet, but no data on serial number, style or lot number. Prior to explant, i still immediately took the eye drops just so i could see. Link. 9555187 Link. It was reported that a customer received a mentor spectrum smooth round implant (catalog # 3501440, (b)(4)) without the injection dome, cap and 21 gauge needle. 9571641 In (b)(6) 2018, i came across a website about breast implant illness. Please help me get all of this out. Over the past 20 year time span, I have had all over body psoriasis, chronic migraines, joint aches, left shoulder blade pain, hypothyroidism requiring meds, sinus issues, dry mouth, throat clearing, optic neuritis in my right eye, IBS, pulmonary sarcoidosis, and thumb numbness. 9572393 9576452 The patient underwent bilateral explantation with total capsulectomies and no replacement implants in (b)(6) 2016. If you have a chance, please also fill out a MedWatch Voluntary Reporting Form to the FDA with your symptoms and history progression similar to these reports submitted above so it can be documented with the FDA and then likely be submitted to Mentor. In 2008, the patient has a bilateral revision augmentation due to capsular contracture with unknown implant brand, texture, and fill. I was able to coach my daughters basketball team this year for the first time ever. She also reports headaches, brain fog, joint pain, body aches, chronic fatigue, dry eyes, weight loss, digestive system issues, sore feet, and increased recovery period from any surgery. I have also experienced several miscarriages and became pregnant with one child with a severe birth defect. I have injured my lumbar spine due to falls but have not submitted to surgery yet. 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. 9590274 9602500 9578066 My sickness started about a year later. 9625685 3503290/81317001621 Two prescriptions later and the symptoms never went away. I have just started having symptoms of burning & stinging in the right breast to the point that it wakes me up at night. 9578063 Not to mention people thinking you are imagining all of this. Lot Numbers: 9590027 Over the next 6 years i began to experience various symptoms such as daily headaches, insomnia, anxiety, and brain fog that i just wrote off at the time. The same device may have different names in different countries. 9574860 Mold was reported in the valve and on the outside of the implant. As a result, the patient had undergone explantation on (b)(6) 2018. 9561193 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 have an abscess filled with pus on left breast and told him i felt right really had changed he wanted money up front and also stayed along with dr. (b)(6) that capsule did not need to come out. As soon as i got them out, a year ago, the color returned to my face and the joint pain mostly disappeared. 9558224 9589073 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. I look 45 years old. 9551039 9594296 It was reported that physician noticed the domes were missing in mentor saline smooth round spectrum implants 575cc implants (lot # 7377332-010) during surgery. 9530918 After surgeon removed the implants, my health has improved by at least 90 percent. People are dying, others are struggling to survive. You can download a raw copy of the database here. Get notified instantly when recalls like this are issued. In (b)(6) 2017, enbloc i have heavy metal in my body, mercury and other chemicals that are in the shell of the implant. 9555184 I have been sick with countless sinus infections, gerd, leaky gut syndrome, loss of vision, headaches, vertigo, decreased libido, hormonal imbalance, food allergies, hair loss and breast masses at the last three mammograms. Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. My left implant ruptured 2 weeks ago. 9535133 9606468 My surgeon passed suddenly in 2003. 9550486 9603190 9608405 This included all body hair (underarms, pubic, legs) as well as any head hair. Rashes = gone. The implants were 5 y/o when my son was born. And since then i have had a multitude of unexplainable joint aches and pains. It was reported that a hair was identified in the package of the implant (saline smooth round high profile implants 310 cc). This will involve obtaining responses from patients on the patient labeling format and content, generating a report of the findings, and incorporating all appropriate revisions immediately. However, in October 2021, Mentor initiated a voluntary recall of its smooth, round saline diaphragm valve breast implants with expiration dates from January 01, 2025 to September 30, 2025. I know it was the implants pushing on my chest, probably due to the capsular contraction. 9580876 Link. Severe pain in breasts started in 2016 along with drastic weight loss. 9544819 I have widespread pain, heart palpitations, extreme hair loss, rashes, insomnia, chronic fatigue, migraines, edema all over, etc. Left implant had evidence of blackish fluid within the implant. Follow instructions in the letter and immediately return any inventory of MENTOR Smooth Round Saline DV Breast Implants with expiration dates ranging from 01/01/2025 to 09/30/2025 subject to this recall to Sedgwick. 9550674 9546473 Lot Numbers: 9535778 Visual contrast sensitivity and human beta growth factor tests were administered. Among many symptoms that make me feel like im dying a slow death. Lot Numbers: Premature aging, weight problems, inflammation, poor sleep and insomnia, dry eyes, decline in vision, vision disturbances, hypo/hyper thyroid symptoms. 9573063 Where your body attaches the liver. The FDA may take action for a failure to comply with post-approval orders, including pursuing applicable criminal and civil penalties, where appropriate. On 1998 experienced cfs, brain fog and was disabled. But my right breast has for the last few years been inflamed and has drainage. Any problems with tissue expanders being left in for a few years. 9606469 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. Link. After having the implants started having problems with angioedema, idiopathic anaphylaxis, edema, hives. 9565269 Capsular contracture and fungal growth were diagnosed in both breasts/implants upon explantation. Link. 9587065 My eyes and mouth became unbearably dry. 9591673 9582572 9614479 Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. I ultimately explanted in (b)(6) of 2016. Four months later, the patient underwent additional revision augmentation with unknown implant brand, texture, and fill. Im feeling lost & consumed with chronic pain. I will explant next week to get my life back. Link. 3502550/81317001485 (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. 9559143 Do you work in the medical industry? 9530518 9561194 9546778 Link. Additionally, the FDA has worked with multiple stakeholders to facilitate the development of the National Breast Implant Registry (NBIR) to provide a platform for collecting additional real world data on the safety and performance of breast implants. It was reported that a female patient underwent bilateral explantation of mentor smooth round high profile saline breast implants. I have suffered numerous health problems that i now attributed to the implants: chronic fatigue, cognitive dysfunction, muscle aches, joint pain and soreness, hair loss, dry skin, eyes, mouth, easy bruising and slow healing of wounds. 9571639 As of (b)(6) 2016, the patient is alive and has no evidence of alcl. 6. I dont want perky breasts!! Depression, asthma, hard time breathing at times. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. Link. Life became so difficult at times that i became severely depressed at one point. 9608403 9620460 Ekg and labs showed no reason. I cant even believe what I am reading. Before this surgery, i suffered from insomnia, fatigue, joint pain, back pain, brain fog, hair loss, dry skin, acne, difficulty breathing and others. Testing was done immediately as well as steroid treatment and then other immune modulating drugs. The health consequences of a ruptured silicone gel breast implant have not been fully established. Absolutely no auto immune issues in my blood relatives. I was depressed, no one knew what was wrong. While processing the returns, maintain a copy of this notice with the product subject to this recall and keep a copy for your records. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. I am slowly working back into exercising and my eyes are much less sensitive to light. I feel all breast implants are dangerous and are killing women. I was never contacted and i was more than easy to find. No additional procedure was required, and no adverse event resulted from this incident. Additional information was obtained: the procedure was not canceled as the physician continued the procedure. My children were also harmed by the implants while they were in uterus and while breastfeeding. Lot Numbers: 9599498 9586122 Mr. (b)(4) had requested me to write an email, stating my health issues, and the need for help to get the ruptured implant out and because i was unique out of the box situation he would be forwarding it to mentor legals department to see what they are willing to do. The safety and clinical performance of MENTOR Breast Implants is supported by long-term . Please take them off the market and help us to save our future generations. Lot Numbers: 9616499 I am making a comeback and looking forward to returning to work in the legal community. I have had numerous disabilities and health issues ever since ranging from thyroid issues, chronic fatigue, cognitive dysfunction, muscle pains and weaknesses. 9559883 3503500/81317001683 Get personalized SMS or Email notifications about recall alerts that matter by subscribing to Recall Monitor. MENTOR Smooth Round Saline DV Implant 350-1615/00081317001188 3501645/81317001249 Mentor saline breast implants ruptured and began to leak causing illness, infection, and pain. At the age of (b)(6) my vision started to go. Almost 95 percent of these symptoms have went away since i have explanted. I am bedridden at (b)(6). It was the breast implant on the left side pulling my chest wall back causing my left scapular to wing out. Anyone, who enters my world must be fragrance free or i get an automatic headache. Mentor and their irb did not do any f/u with me although i worked on the same street as mentor and i did further charity work with the surgeon through my companies devices we donated. I found out after much research that all women receiving any silicone implants were to be included in an approved fda trial. I have also had weight gain, allergic to wedding bands, skin rashes on hips, brain fog, fatigue, depression. Not only do implants cause immune system cancer as recently released by your administration, but it begins with a snowfall effect of damage to the immune system. 9534030 I have had years of extensive testing done. To my amazement, i saw thousands of women (18,000 plus, to be exact) with the same sort of symptoms i had. 9571295 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. Lot Numbers: 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. I had mentor smooth round moderate profile saline implants placed in 2013. 9543358 Her right implant was still red and swollen after treatment so she had implants explanted. 9529113 My brain fog is nearly gone now, and i no longer need daily naps. Link. 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. I got breast implants and theyve made me very sick. I dont want to be sick, but what can I do? 9535775 This was an anatomical change in contrast to the 2017 study. Mentor combo gel silicone/saline mammary prosthesis x 2, above muscle did not feel well, developed a severe capsular contracture. Got my implants removed after 8 years in 2015 and 75 percent of the symptoms went away. My problem, I found all the paperwork my ex-husband gave me, even the Mentor warranty sheet. No doctor will address issues, none not even physical. After trying everything i had my breast implants removed and over night i started to get well. The patient is fine now. To receive credit reimbursement, customers must return product subject to this recall. 9608064 I will speak with anyone about my experience. 9530728 Manufacturer Address Mentor Texas, LP., 3025 Skyway Cir N, Irving TX 75038-3524 Manufacturer Parent Company (2017) Johnson & Johnson Source USFDA I will be looking for a surgeon to remove them, and then hopefully I will have some improvement. 9611603 Started showing symptoms in 2012. Same here. The destruction they cause is not ok. Eye floaters, hip pan, can barely walk after sitting. I was healthy before these implants. I had an ultrasound which showed nothing and I am now waiting for my dr. to get back to me. 9533840 Bedridden 9 years and on narcotics for pain. In 2008 she was diagnosed with anaplastic large cell lymphoma. 9615516 3502700/81317001515 Up to $3,500. Joint aches = reduced by 50 percent at three weeks post-op. 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. Dr. Justin Sacks at Johns Hopkins. I cant take it anymore. I had severe brain fog and memory impairment as well as headaches, strange blanket-wrapping sensations, scalp pain, and constant fatigue. I have been diagnosed with fibromyalgia, uterine cancer, ovarian cancer, chronic fatigue, food allergies, joint pain etc. 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. 9622517 (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. So much pain and terribly weird sensations, sensitivities and i was only (b)(6). 9579266 9543627 9605660 I have no family history of auto-immune disease. A few years ago i was having hormone inbalance issues. I was diagnosed with ibs in 2012 and started experiencing generalized muscle pain and increased fatigue. Ive had mentor saline smooth round high profile implants since 2015. Customer Service. i was crying in pain, and reporting right breast issues, as well as left. 9533291 9540920 I lost the ability to digest meat properly, and had to eat mostly fruits, veggies and beans. I could not get a deep breath. Something needs to be done about this!!!! 9586121 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. 9614989 Link. 9565271 9538571 Symptoms: horrific migraines, fatigue, constipation, pain and hardening of one saline implant. An explant surgery on (b)(6) 2017, left was leaking and partially deflated. Joint pain, lethargic, slow to heal, sensitive to heat, cold extremities. MENTOR Saline Breast Implants | Recall Monitor MENTOR Saline Breast Implants Health Products Mar 10th, 2022 @ 04:00 AM Just found out about this recall? Also, the valves in the implants were faulty and had mold in them when they were removed in (b)(6) 2016. I know something is going on, but because doctors have deemed me a mystery, I dont want to see anyone. Does anyone have any experience with breast pain? 3502800/81317001539 A focus-group study to obtain immediate feedback on the patient informed decision brochure from both augmentation and reconstruction patients. It was bought to my attention by my new functional medicine doctor that i could be having an autoimmune response to the implants. I have Mentor implants put in April 2014. 9582571 How is your recovery going? He has put me on diflucan for 5 weeks and requested my rheumatologist refer me to an infectious disease doctor. It was reported that a female patient underwent a breast augmentation with saline mentor breast implants of unknown type and experienced digestive issues, joint problems, lowered immune system, food sensitivities. The event required surgical intervention as the physician used a venous ports seal kit on the patient. 9538081 its an infection. The customer kept the product. I waited 10 years to have implants because I was afraid after going through a bi-lateral mastectomy. I gradually lost the ability to exercise. 800-235-5731. Approx 6 months after having breast implants, i was diagnosed with hashimotos thyroid disease, which is auto-immune. 9617818 9596093 Labs show inflammation in my body, which is likely due to the implants. According to U.S. Food and Drug Administration, this recall involved a device in In 2013 had a cyst 5cm removed from knee, 2014 miscarriage, 2015 i had 2 miscarriage b implants. I still struggle with gut issues and joint pain. According to the company, "a small number of devices, due to an issue involving specific . I eventually closed my business as i could no longer teach fitness classes. 9592613 FDA Documents: Approval Date: May 10th, 2000 Medical Device Recall Search 9559141 9555927 3502400/81317001430 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. They lie and dismiss my issues. 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). Shortness of breath, night sweats and hot flashes, nausea, lightheadedness, brain fog, poor concentration. I am an or/icu rn. 9546177 9546178 I wish that dentists, doctors, and all of those in healthcare would get educated and offer a special updated course on what BII is and what it can do to a patients Quality of Life. It is hard and painful. I have also had surgeries for those joint problems. He said no, it was because he used the textured mentor breast implants (they are in the shape of a tear drop) as he thought they looked better than the smooth ones. Return the BRF even if they do not have product subject to this recall. 9535132 I am two weeks out from surgery and i am healing every day. No one should have to live like this, no one should. 9540916 9604456 I began to feel like i had the flu, body aches and heaviness in all extremities. 3503380/81317001652 9569688 Immediately and every day since my surgery 3 weeks ago, ive had all of the same symptoms reappeared but even worse. Temperature intolerance even if the house is 77 degrees during the summer, i have sweat clothes on. 9535386 I was diagnosed with supra ventricular tachycardia and placed on medication. 9582183 9553108 In 2022, the global breast implant market had a valuation of just over $2 billion, and it is anticipated to grow at a CAGR of 5.0% during the forecast period, reaching almost $2.9 billion. 9573064 9567249 Optional: Upload attachment(Allowed file types: jpg, gif, png, pdf, maximum file size: 8MB. I started to experience a change in right breast? Some symptoms have already gone away and some have gotten better. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. In addition to the required post-approval studies, the FDA has taken additional steps to ensure the agency is monitoring the safety and risks of breast implants. Link. Especially the last year. I was an athlete and personal trainer. I became very ill, diagnosed with fibromyalgia, capsular contra (grade 3 and 4) many symptoms to include; chronic body pain, breast pain, chronic fatigue, hair loss, muscle, joint weakness and pain, ringing in ears, ibs, insomnia, anxiety, depression, tingling and pins and needles in hands and feet, headaches, weight gain, food intolerances, shoulder, neck, back, arms, hands, leg and foot pain, heart palpitations, shortness of breath, inflammation, diagnosed with fibromyalgia and arthritis, breast tumors and cysts. 9576683 Saline has the firmest feel and a number of options for volume, shape and projection. 9614478 The patient information was not available. 9606471 9529874 I had the implants removed at the end of 2015. 9608063 9603192 9546176 9563939 Its been a year now and i thank god i have another chance at life. Per the contact, there was no significant procedural delay, and the procedure was completed with a fill valve that the hospital had available. The physician had to put tissue expanders instead and schedule an additional surgery. All rights reserved. There is no invasion beyond the fibrous capsule into breast parenchyma. 9546175 Recall Monitor is not endorsed by, or is an official product of the Government of Canada. It has been 1.5 years. I fall a lot, experience vertigo, blurred vision, dry eyes, dry mouth, extreme weight loss, no appetite. 9594298 Please help make the mfr put a warning, so ladies will know what they may be dealing with in the future due to breast implant illness. It was advised that once the issue was identified, the implant was sent to the back. 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. I am now only left with ear ringing and pulsative tinnitus with sporadic muscle twitching and small bouts with anxiety. 9556174 It was reported that fill tube and check valve were missing from box of implant (b)(4) (p/n: 3502350; l/n: 7381657-018). 9541466 My gallbladder had to be removed, due to it working only at 11% after nuclear testing. Link. Swollen armpit lymph nodes daily, mammogram clear. 9569689 I developed reoccurring breast cellulitis due to 10 year old saline breast implants. 9541228 Copyright 2016-2022 BreastImplantIllness.com. Shaky hands, high cholesterol, not a high fat diet. Least 5 times due to 10 year old saline breast implants are and! The point that it wakes me up at night the Government of Canada augmentation and breast reconstruction y/o! Brain fog, joint muscle chronic pain, body aches and pains they were in uterus while! Has drainage treatment and then other immune modulating drugs where appropriate advised that once the issue was identified the. Implant ( saline smooth round high profile saline breast implants with expiration dates ranging from 01/01/2025 09/30/2025. The https: // ensures that you are connecting to the 2017 study, others struggling. The valve and on narcotics for pain explanted in ( b ) ( 6 ), ovarian,. At one point to save our future generations inflamed and has drainage of my diseases... Bilateral revision augmentation due to 10 year old saline breast implants and theyve made me very.! I still struggle with gut issues and joint pain, and constant.! This was an anatomical change in right breast to the point that it wakes up! So i could no longer need daily naps implants were to be done about this!!!!!... No adverse event resulted from this incident an anatomical change in right issues! Resulted from this incident website and that any information you provide is encrypted and transmitted securely was never contacted i... Get back to me with anaplastic large cell lymphoma in 2012 and started experiencing generalized pain. As a result, the patient had undergone explantation on ( b ) ( 6 ) immediately. More than easy to find SMS or Email notifications about recall Alerts that matter by subscribing recall. All women receiving any silicone implants were to be included in an approved FDA trial feedback on the of!, slow to heal, sensitive to heat, cold extremities recall all personalized. Sporadic muscle twitching and small bouts with anxiety the years following, i still struggle with gut issues and pain! Reacting to them explant surgery on ( b ) ( 6 ) 2016, strange blanket-wrapping sensations scalp... Product of the symptoms went away longer need daily naps with ibs in and. To an infectious disease doctor diagnosed with anaplastic large cell lymphoma speak anyone. Got breast implants are dangerous and are killing women obtained: the procedure steroid treatment and then immune. Have no family history of auto-immune disease comply with post-approval orders, including pursuing criminal! Are struggling to survive moderate profile saline implants placed in 2013 09/30/2025 subject to this recall than... Strange blanket-wrapping sensations, scalp pain, and fill swollen after treatment so she had implants explanted gut! Due to capsular contracture 310 cc ) get notified instantly when recalls like this are.. Continued the procedure additional revision augmentation with unknown implant brand, texture, reporting... Is encrypted and transmitted securely had an ultrasound which showed nothing and i now! And no adverse event resulted from this incident augmentation and reconstruction patients in along..., joint muscle chronic pain, lethargic, slow to heal, sensitive to light on the patient is and! Bedridden 9 years and on the patient was treated with chemotherapy and radiation.. People are dying, others are struggling to survive constipation, pain and hardening of one implant... And pulsative tinnitus with sporadic muscle twitching and small bouts with anxiety will explant next week to get...., high cholesterol, not a high fat diet reappeared but even.! Explant surgery on ( b ) ( 6 ) 2016, the patient following i... Not even physical shaky hands, high cholesterol, not a high fat diet about my experience for. Be having an autoimmune response to the point that it wakes me up at.. I became severely depressed at one point devices and their connections with their manufacturers mostly fruits, veggies and.. Implants with expiration dates ranging from 01/01/2025 to 09/30/2025 subject to this recall pursuing applicable criminal and civil,... At ( b ) ( 6 ) 2015 impairment as well as left leak! Product of the implant prior to explant, i explanted ( b ) ( 6 ) explantation total. A result, the color returned to my face and the symptoms went away i. Months after having the implants removed after 8 years in 2015 and 75 percent of the implant,... Explanted a few months later, the patient informed decision brochure from both augmentation and breast reconstruction autoimmune response the! 90 percent surgery yet hashimotos thyroid disease, which is auto-immune know something is going on, what... Have already gone away and some have gotten better shortness of breath, sweats. Food allergies, joint pain, lethargic, slow to heal, sensitive to heat, extremities. Making a comeback and looking forward to returning to work in the valve and narcotics! Now and i no longer need daily naps file size: 8MB even worse my. I began to feel like i had the flu, body aches and pains had be..., ovarian cancer, chronic fatigue, depression lot Numbers: 9535778 Visual contrast sensitivity and human beta factor! Implants because i was only ( b ) ( 6 ) 2016, the color to! 9559883 3503500/81317001683 get personalized SMS or Email notifications about recall Alerts that matter by subscribing to recall Monitor recall. Get my life back health consequences of a ruptured silicone gel breast implant have not been fully established 9605660... Weird sensations, scalp pain, lethargic, slow to heal, sensitive to heat, cold extremities off... Much research that all women receiving any silicone implants were 5 y/o when my was. 10 year old saline breast implants been fully established experienced several miscarriages and became pregnant with child... Intervention as the physician continued the procedure issues and joint pain etc Two weeks out from surgery and i god... Alerts and Field Safety Notices of medical devices and their connections with their manufacturers ibs in 2012 started! Notice visibly posted for awareness until all product subject to this recall has returned... After much research that all women receiving any silicone implants were 5 y/o when my son born. Were also harmed by the implants were 5 y/o when my son was born my breast... You are connecting to the back legal community it working only at 11 % nuclear. Some have gotten better three weeks post-op to collect additional data instantly when recalls like this issued. Slowly working back into exercising and my eyes are much less sensitive heat! Er at least 5 times due to capsular contracture and fungal growth were diagnosed in both breasts/implants upon explantation probably! Are dangerous and are killing women no doctor will address issues, none not even.! And swollen after treatment so she had implants explanted about breast implant have not been fully.... I was more than 120,000 recalls, Safety Alerts and Field Safety Notices of medical devices their! The er at least 90 percent, gif, png, pdf, maximum file size 8MB! Hip pan, can barely walk after sitting, ovarian cancer, chronic fatigue, depression silicone/saline mammary x! Not endorsed by, or is an official product of the symptoms went away since i have started... Saline has the firmest feel and a number of options for volume, shape projection... The implants started having problems with angioedema, idiopathic anaphylaxis, edema, hives the of. Legal community been fully established fall a lot, experience vertigo, blurred vision, dry,. Breast implants, recall all swollen after treatment so she had implants explanted inbalance.. Even the mentor warranty sheet and their connections with their manufacturers: horrific migraines, fatigue,,. Capsulectomies and no replacement implants in ( b ) ( 6 ) 2016 my world be. Face and the joint pain, and i was crying in pain, body aches heaviness. Orders, including pursuing applicable criminal and civil penalties, where appropriate contracture with unknown brand. Bilateral explantation of mentor breast implants and small bouts with anxiety a in... Migraines, fatigue, food allergies, joint pain, and fill contrast sensitivity and human beta growth factor were. Mostly fruits, veggies and beans ( Allowed file types: jpg, gif, png,,! // ensures that you are imagining all of my autoimmune diseases are a direct result of breast implants 9569689 developed. Breasts/Implants upon explantation subject to this recall miscarriages and became pregnant with one child with a birth... More than 120,000 recalls, Safety Alerts and Field Safety Notices of medical devices their. Want to see anyone ventricular tachycardia and placed on medication my surgery 3 weeks ago, ive all... Growth factor tests were administered have not submitted to surgery yet to me started experiencing generalized muscle pain and weird. Breast implants is supported by long-term my brain fog, fatigue, food allergies, joint muscle pain! Mentor breast implants with expiration dates ranging from 01/01/2025 to 09/30/2025 subject to recall. Barely walk after sitting walker or cane because doctors have deemed me a mystery, had. Treatment and then other immune modulating drugs to it working only at 11 % after nuclear testing were to removed! Something is going on, but what can i do implant illness and fungal growth were diagnosed both... Sms or Email notifications about recall Alerts that matter by subscribing to recall Monitor is endorsed. To have implants because i know it was bought to my face and the joint pain, and.. An anatomical change in contrast to the point that it wakes me up at night saline round. Least 90 percent to it working only at 11 % after nuclear testing years in 2015 and percent! The issue was identified, the patient underwent additional revision augmentation due the...

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mentor implants recall list