Rheumatologist said i am at high risk for lymphoma. Link. We have helped over 300,000 people with their problems. Had frozen shoulder. The nipples were 99% erect and felt swollen for most of the time. f1NW I had silicone gel breast implants placed under the muscle. Epidurals and physical therapy for years. 5. Vitamin deficiency and i take weekly high dosages of vitamin d (50,000) and daily vit d (8,000) and im barely in the normal range. Extreme hair loss that has created balding (alopecia) on my scalp. The hospital has denied the mammogram caused the rupture but both at the same time is so obvious. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. Bia alcl swelling around implant need aspiration. The purpose was to evaluate the association between Mentor MemoryShapeSilicone Gel Breast Implants and five rare disease outcomes: rare connective tissue diseases, neurological diseases, brain cancer, cervical/vulvar cancer and lymphoma. I was sent home and within 2 days i began hemorrhaging from left breast. Difficulty swallowing/fullness in throat, decreased libido, low energy, exhausted, weak, memory loss, difficulty concentrating and brain fog. Important information: i have been very diligent in following doctors protocols and have preferred diet and exercise over medication if at all possible. It was reported that packaging for implant sm mpp gel 400cc (p/n: 3504001bc; l/n: 7402435-060) had hole in it. Initiating a recall claim for a Mentor implants recall can be a stressful process on top of what is already a stressful situation. waiting for scheduled explant and lymphadenotomy when i will be hospitalized. )7:Evvc},,dK9%"Ty.73&X6H(TQzz?n7?"=O[U? I have this implant, I had it 4/2017. MentorMemoryShape, MemoryGel, and Memory Gel BOOST implants are recommended for augmentation patients who are at least 22 years old, while the saline breast implants are indicated for patients who are 18 years and older. Link. Multiple attempts have been made to obtain more event details, however, no additional information has been made available. MemoryShape and MemoryGel Post-Approval Study:Intended tofollow women for 10 years, commencing in 2013. As soon as 4 months after implantation i had an emergent visit to the er for vertigo persistent vomiting and dizziness. I could not take myself to these appointments. Thank you for the many experiences posted. The next day, my plastic surgeon agreed to explant my mentor gel-filled implant stating that he could not guarantee that the implant was causing my debilitation and that i might not regain my health. Do you think that made a difference in the muscle deformity? 0 Had breast implants put in and have had failing health since. In (b)(6) 2016, the patient underwent surgery and the mentor memory gel implants were removed. April 2013. 350-2425, SMOOTH ROUND HIGH PROFILE SALINE-FILLED MAMMARY PROSTHESIS, 350-3210 I have been diagnosed with sjogrens, myalgia, low c4 and anemia. Tested positive ana for possible lupus. These were requirements of the Approval Order. I was hospitalized for rapid heart rate and low blood pressure. **1 y* Loss of interest and pleasure in doing activities. They ranged from fairly benign to increasingly more serious and problematic. Over time, the number of health concerns increased or became increasingly worse. I was wondering what steps to take to ensure that i was healthy and safe. I am hoping i will get better after explanting. Posting Date. Implants placed under a mentor trial in 2004, in 2005 i had revision surgery all the right implant capsulized within six months. By this time, too, i began feeling malaise, and i then was weakened to the point of being unable to walk unaided. I feel like a virtual shell of the person that i once was. Using DoNotPay for assistance in resolving recall issues other than breast implants is just as easy. Sensitivity to heat, sunlight and florescent lighting. 5 years ago. Weight began to plummet, as did blood pressure and just all over general malaise. 10. The shell is filled with MemoryGel , Mentor's proprietary formulation of medical grade silicone gel, and is constructed of successive cross-linked layers of silicone elastomer. Her face started to swell when she got cold. of Irving Texas initiated a recall of their MemoryGel breast implants on July 01, 2016, due to a labeling mix-up Consignees were notified by mail and a follow-up visit by a sales representative Recall terminated December 9, 2016 Symptoms and Side Effects of Defective Breast Implants Smooth surfaced implants are not affected by. My first symptoms in early 2000 with migraines. Muffled ears like swimmers ear. Once left breast was opened, implant was ruptured and silicone had settled into the fascia going completely underneath my arm pit and almost to my back. Then depression and daily anxiety became an issue. Insomnia, feeling dizzy, or faint, almost blacking out (everything goes dark and i see stars). Within the past 8 months i heard about breast implant illness, i do believe i suffer from it. Finally, i developed a goiter and a high cortisol level. MemoryGel breast implants come in either a textured or smooth surface shell and are available in a wide range of sizes and profiles to fit your body. My doctor said there is nothing that can be done to prevent or fix the deformity once the implants are removed. Tingling and numbness in face, hands, and feet. Began with recurring upper respiratory infections, cellulitis infections, staph infections, lymphedema put on 100 pounds. endstream endobj 309 0 obj <>stream Now all i want is my life back. Per patient, the physician believes the right device was defective. To be able to walk and have energy again, and hopefully for the arthritis symptoms to diminish. As of today, (b)(6) 2017, im taking cipro 500 mg twice daily, drain is still intact, takes me over 2 hours to bathe, dry my hair and dress, because im fatigued. Please take these off the market. This study wasto be conducted in Denmark, Germany, and the UK. Fast--You don't have to spend hours trying to solve the issue, Easy--You don't have to struggle to fill out tedious forms or keep track of all the steps involved in solving your problem, Successful--You can rest assured knowing we'll make the best case for you. These were conditions of FDA approval and were required by theApproval Order. I want them removed as soon as possible because i know they are toxic and my body is reacting to them. Cant handle the sun anymore, can no longer jog/run. Within 6 months of that time frame, i started to have medical concerns, which were unusual for me. Unexplained rashes, difficulty walking and breathing, pain in my joints, couldnt touch my body. I believe as i stated before they have exacerbated my autoimmune challenges. I have had numerous health issues over the years since the implants but this winter, things got worse. SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT W/DIAPHRAGM VALVE. I am hoping my upper back pain goes away and my health recovers. Was sent to podiatrist and rheumatologist. I was extremely healthy at time of the implant surgery and was told these were fda approved and very safe. On (b)(6) 2009 is the date i had surgery to have implants. I eventually had to remove the left fallopian tube and both ovaries due to the severe pain. k-9(J((5*k?aT/SZ D z:Trx%(o8L?h{C5t*Q Link. This is so my body can have an opportunity to try and heal and settle down from all of the reactions my body is experiencing. Manufacturer Address Mentor Texas, LP., 3025 Skyway Cir N, Irving TX 75038-3524 Manufacturer Parent Company (2017) Johnson & Johnson Source USFDA I explanted 3 weeks ago and all my pain is gone. DoNotPay can assist you with a simple, easy-to-use process in one place. Redness all over my body. Patient also had developed rashes and pruritis. The new ones that suppose to be fda approved and safe ones. The patient must be given the opportunity to initial and sign the patient decision checklist and it must be signed by the physician implanting the device. I can walk short distances with the use of a cane; i still have to use an electric scooter or be pushed in a wheelchair if i have to stand for long or go very far. Updated labeling to communicate long-term study results is pending for all implants in this table. 350-3460. DoNotPay will send your implant recall request to the manufacturing company on your behalf, asking for a refund or replacement. Fibromyalgia, ms symptoms high blood pressure, chronic fatigue, ibs burning sensation in body, frostbite sensations on outside of my body. Note: If you need help accessing information in different file formats, see Along with that were 35 other symptoms. I got mentor implants. It was reported that the patient replaced saline implants which was implanted on (b)(6) 2003 with mentor cohesive gel implants in (b)(6) 2011. What they are clear about is that i have autoimmune/inflammatory issues in addition to memory issues/brain fog. Conclusions: Mentor MemoryGel Silicone Breast implants represent a safe and effective choice for women . 350-3270 Fatigue pressure on face (under eyes, around nose) constant headaches, tingling in hands and feet (fall asleep, drop things, difficulty opening things, typing etc). She also suffered persistent mild hardening, fatigue, weakness, high homocysteine, moderate c-reactive protein, photosensitivity, hives, itching after sun exposure, brittleness and cracking of nails, easy bruising, shortness of breath, cognitive difficulties, metallic taste in mouth, night sweats, headaches, foul body odor, cognitive dysfunction, nausea, dizziness, hashimotos disease, skin rashes, digestive and gastrointestinal issues, low white blood cells, elevated thyroid and autoimmune antibodies, epstein-barr virus, cytomegalovirus, varicella zoster, and pain (generalized). Each implant is filled with Mentor's cohesive gel, which holds together uniformly and retains a natural give that better resembles breast tissue. This impact is widespread and debilitating. Medical Device Recall of MENTOR Smooth Round Saline DV Breast Implants Page 1 of 6 Event #7209. No further information is known regarding the patients medical history, status, hospitalizations, medical or surgical interventions that were performed. Have heavy metal toxicity and silicone has been found in my lymphnodes of my left armpit and chest wall. Link. Unable to walk. I had silicone breast implants and had no idea they both got ruptured. Was immediately put on meloxicam for inflammation. I was unable to walk or open windows or cupboards. I have that as well I never thought about any of my issues (lots) having anything to do with my implants in 2017 I would definitely think about taking them out to NOT have the issues / pain Ive dealt with this long. I was given iv cipro for several days. I had to have a double mastectomy in 2009 with immediate breast implants. Alcl stage and alcl treatment are unknown. Due to length of initial surgery as well as length of hospitalization, i chose to wait. I have chronic candida overgrowth hormone fluctuations, chronic fatigue, various gut issues, digestion problems. MENTOR Breast Tissue Expanders. Her email is [emailprotected] and phone number is (301) 796-6134. Believe my silicone breast implant was ruptured after a mammogram. I had follow-ups with my surgeon and everything seemed to be fine but the symptoms continue to become worse and more frequent. Link. Link. Cultures were done, idc was called in and i had pseudomonas aeruginosa and serratia marcescens. (Unknown if it is Mentor saline or silicone). The patient believes that the discoloration is a fungus growth inside the right device. The sale and distribution of Mentor Breast Implant Devices are restricted to users and/or user facilities that provide information to patients about the risks and benefits of the device prior to its use in the form and . For Additional Information Contact. The mammogram film showed the bursting of the implant. The fda say they are safe. Large Study:The follow-up rate was 20.1% at 7 yearsand the final report is on year 9 in 2015. As time went on symptoms worsened with high blood pressure headaches with vomiting more frequent causing me to miss work excessive thirst, urinary urgency and changes in menstrual cycle neck pain. I happened to notice that one of my breast implants (from breast cancer in 2000) had gone flat. The .gov means its official.Federal government websites often end in .gov or .mil. MENTOR Warranty Link. No money and insurance will not cover? Symptoms: fatigue, endocrine issues, depression, panic attacks, insomnia, joint pain and cognitive dysfunction. It took me that long to convince my doctor that something was wrong!!!! endstream endobj 312 0 obj <>stream Frequent migraines with vomiting extreme fatigue hair loss blurred vision acting joints right arm-numbness and pain 20 pound weight gain and bloating of abd and frequent heartburn, brain fog with. I had smooth mentor memorygel breast implants placed under the muscle 2. I have learned that the mentor company product was approved but was supposed to complete a 10 year study that has now been cancelled. Within two months of my operation, i had an odd perspiration odor which remained with me permanently. Link. I obtained a family doctor at this point who subscribed thyroid meds and followed me with maintaining therapeutic tsh levels. My right mentor high profile silicone breast implant shell has completely disintegrated, implanted in 2012. Worsened over a period of 5-7 years post implant. I had 220 cc silicone breast implants and their capsule, which were implanted in 1987, burst during a routine mammogram. Ive been to the doctor many times complaining about the lymph gland being swollen and getting dismissed repeatedly, i could really use to use some advice or support. Link. 350-1620 I have elevated bilirubin levels from toxic overload and have been diagnosed with gilberts syndrome. Link. I have mentor cohesive gel breast implants and experienced symptoms almost immediately. UT]b$c} She had breast asymmetry on the right side. Two weeks after getting great implants, lymph nodes began to swell and are still swollen. Loss of appetite, weight loss. However, in October 2021, Mentor initiated a voluntary recall of its smooth, round saline diaphragm valve breast implants . I have experienced fatigue, joint pain (hips), muscle soreness, red and sore eyes, weight gain, inability to take deep breaths, inability to lose weight , double vision and trouble recalling words. Seven years ago i went from my lovely, natural b-cup to silicone (mentor memory gel) d-cup breasts. Instructions for Downloading Viewers and Players, Class 2 Device Recall Mentor MemoryGel Breast Implant. The list goes on. I have lost the ability to live my life, play with my son, spend time with friends, make plans, and keep them. MemoryGel Breast Implants (Mentor Worldwide LLC, Irvine, Calif.), approved by the U.S. Food and Drug Administration in 2006 for breast augmentation in women aged 22 years and older and for breast reconstruction in women of any age, consist of a single-lumen, round silicone elastomer shell, with a patch on the posterior side, and filled with a cohesive silicone gel. Ringing in ears, metalic taste in mouth, skin rashes bug bites, scratches and other wounds take forever to heal. I could no longer get out of bed and had to have assistance bathing and dressing. I am only (b)(6) and should not have any of these health issues. The implants were silicone made by mentor 600cc. I got severe spinning vertigo that lasted 6 years. 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. Per the customer, the plastic wrapping the implant boxes was also damaged. For the most part I'm pleased with how they look but unfortunately I'm having the implants removed in two weeks due to autoimmune reactions to them. FDA Recall. I actually held the implant and was assured the silicone would not leak out and if implant were punctured, the silicone would remain inside implant. It was reported that a (b)(6) year-old female underwent primary augmentation surgery using mentor silicone implants. 350-3290 Contact the relevant medical authorities who conducted the surgery and request an updated Mentor breast implant recall information. Bruise easily. The patient reported to have several undisclosed illnesses within months of getting the implants put in. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. No further information was obtained. I was fine for the first two years. I felt like i was dying. I contacted a plastic surgeon at (b)(6), and scheduled an explant. Constant lower back pain (and right hip). It was reported that a (b)(6) female patient with history of breast prosthesis implantations was diagnosed with left breast cancer. At present, i cannot sit for long, tire easily and cannot drive far. They admitted me and performed exploratory surgery, found I had a ruptured right fallopian tube, which they removed. Within a year of receiving mentor silicone high profile breast implants my health had declined tremendously. After having the breast implants removed on (b)(6) all the pain and disorders are gone. If I had been told that any of these possibilties, I never would have had them put in!!!!! I had breast implants on (b)(6) 2016. My newest symptoms are the perioral dermatitis, migraines accompanied with throwing up, swollen tongue, breast soreness 1 side. Only need to get an mri if you suspect a rupture or feel contracture. Dry eyes (difficulty crying) dry mouth (always thirsty) dry throat (difficulty swallowing pills, food gets stuck) gel hoarse, especially in evenings. I had severe discomfort, pain and burning for over a year!!!! Link. More than 10 numbers, contact manufacturer. This began to get out of hand this (b)(6) and i began to research to figure out what was going on. Tell us about your purchase, including the product name, brand, store you purchased the item from, price, and date of purchase. 350-3230 The symptoms are all still there and the issues persist despite medication and extreme lifestyle and diet overhaul. Link. Mentors failure to address these concerns and comply with its post-approval study requirements is a violation of the firms pre-market approval order., FDAs warning letter to Mentor Worldwide LLC (Mentor). At this point, though, i really just want to feel healthy again and get these toxic bags out!. I have chronic widespread pain and digestive trouble. Just came across the breast implant illness. They are supposed to last 10 years. I hurt everyday and have migraines. I have had thyroid cancer, parathyroid tumors, thyroidectomy with parathyroidectomies, inability to work for over one year, fibromyalgia, asthma and copd the list goes on and on. So, i had the surgery to replace them and it was an absolute breeze! D epression, anxiety, brain fog, inability to concentrate, sensitivity to temperature, smells, blurred vision may be just the beginning and I have no idea who might help in this. Mentor Texas LP. Some respondents suggestedthat the true purpose of the brochure was to protect Mentor, rather than inform patients about breast implant surgery. Upon the surgeon's request, saline deflations can be replaced with a Mentor silicone gel implant for a flat rate of $250 per requested replacement product. First, the FDA issued orders restricting the sale and distribution of breast implants to help ensure that patients considering breast implants are provided with adequate risk information so that they can make fully informed decisions. PMAs with Product Code = FTR and Original Applicant = MENTOR CORP. The product was a silicone gel breast implant. I have hot and cold sensitivities. The site is secure. The new labeling approved on October 27, 2021 follows from the labeling recommendations described in the FDAs September 2020 guidance. FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements (3/19/19). Mentor Worldwide Historical Implant Data 1985 May 2018. MemoryGel Breast Implants provide a soft, natural feel desired by patients. Lymphedema, autoimmune disease, anemia, permanent muscle and nerve damage, silicone and heavy metal poisoning, loss of appetite, vomiting pain, blood and fluid build up around implants, pain in joints, dizziness, brain fog, confusion, swollen breasts, arms and fingers as well as face, weight loss, faint very easily, stomach pains, swollen lymph nodes and glands, depression, anxiety. When recalls are as vital as a Mentor breast implant serial number recall, you should never ignore them. In fact, since implantation i do not have a taste of alcohol and have become sick whenever i have tried to drink even in moderation. Lowered immune system, and i get sick (strep throat, colds) and i never used to, slow clearing of colds. This implants are taking my life away . Learn More. Could barely walk. I have seen 10 doctors over the past 3 years and i have been able to manage, but most of my symptoms remain at large. Link. I have pictures, notes and many bills. I was diagnosed with ulcerative colitis back in 1986 since ive had the saline implants removed and silicone replaced them, i have been extremely ill and never once did a doctor suggest it could have been for my implants. Irvine, Calif., (January 13, 2021) - Mentor Worldwide LLC, the number one global brand in breast aesthetics, and part of . 5. Link. Don't let time and effort get in the way of taking advantage of getting what you need or are owed. Shoulder and neck pain, pain under my rt rib. I have been on prescription medications for those. None of them would even acknowledge it because they said all implants are fda approved and then would change the subject. Chronic fatigue, weight gain, inability to be active. 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