H\j >wIJ$PC$uBS{+{0inepKg& A5 vOg+:{\(mADuXx:EyyCHpuD?(h .4ZF?f83QEmQP >g>?4)0QgM5MqM7*z Y More than 10 numbers, contact manufacturer. Mri report ((b)(6) 2017) cites patient had augmentation revision procedure in 2008 (no further information stated; no information on types or brand of implants used). The alarming conflict of interest in the manufacturers sponsoring the studies and in the plastic surgeons handling the study is astounding. URGENT: FIELD SAFETY NOTICE . Mentor Textured Silicone Implants. I had silicone implants put in (b)(6) 2014 and by (b)(6) 2015, i was getting sick. Instructions for Downloading Viewers and Players. 2 I obtained a family doctor at this point who subscribed thyroid meds and followed me with maintaining therapeutic tsh levels. (Unknown if it is Mentor saline or silicone). Link. The FDA had required this study to be done for 10 years, according to guidelines of the Approval Order in 2006, but the Final Reportwas submitted in year 6 of the study in 2012. It was reported via an fda medwatch form (#mw5072162) that a patient who underwent breast prosthesis implantation with a mentor textured gel device on (b)(6) 2015 was diagnosed with bia-alcl. Have had multiple visits to the ent and walk in clinic. She had breast asymmetry on the right side. I am hoping my upper back pain goes away and my health recovers. Extreme swelling throughout my body had to use a lymphatic drainage machine 2xs per day for 75 minutes. (Unknown if it is Mentor saline or silicone). Her email is [emailprotected] and phone number is (301) 796-6134. Not every women is genetically the same and there are many that will not be able to tolerate the implants. Using DoNotPay for assistance in resolving recall issues other than breast implants is just as easy. I believe since i already had autoimmune disorders i should have never had silicone implants. Link. Pain persisted for months but eased in time. endstream endobj 305 0 obj <>/Metadata 24 0 R/PageLayout/OneColumn/Pages 302 0 R/StructTreeRoot 43 0 R/Type/Catalog>> endobj 306 0 obj <>/ExtGState<>/Font<>/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 307 0 obj <>stream Link. The symptoms are all still there and the issues persist despite medication and extreme lifestyle and diet overhaul. Pain is intense, particularly in the mornings or after sitting for a while. a few months later things went downhill fast! I am already disabled and with this in addition its just too much i am devastated. These implants did not make any contact with a patient, and the implants were sent back to mentor for replacement. DoNotPay can assist you with a simple, easy-to-use process in one place. The FDA had required this study to be done for 10 years. Fibromyalgia, ms symptoms high blood pressure, chronic fatigue, ibs burning sensation in body, frostbite sensations on outside of my body. She became very ill and had been sick during a business trip, with a fever, swollen left breast and lymph node infection. I had reconstruction due to breast cancer with mentor memory gel silicone implants 300cc. I was a very healthy, active person up until all of this happened. Night sweats. Breast tissue was not sent for histology at that time. Link. All i want is for my original breasts to look normal and not have the muscle flex deformity. There i saw my right implant was completely ruptured. 1 MENTOR Breast Implants are backed Medtronic and adrenal issues. Here are all the ongoing symptoms: migraines, anxiety, fatigue, temperature intolerance, sensitivity to smells, burning pain in breasts, inflammation in breasts, weakness, chronic back pain, whole body dryness, pigment discoloration, blurred vision, word retrieval, concentration, and rapid weight gain. Weekly b12 injections. I was given iv cipro for several days. Seven years ago i went from my lovely, natural b-cup to silicone (mentor memory gel) d-cup breasts. I started having serious difficulty breathing at all times, and especially when laying down at night. Patient suffered pain on the left side for the past year and it was getting worse. Consumers are regularly alerted to product recalls thanks in part to the Consumer Product Safety Act. Panic attacks, chest pain, breast pain, inflammation, depression. Link. I have been on prescription medications for those. Shortly after, i began to experience a myriad of unexplained symptoms including anxiety, thyroid levels off, debilitating fatigue, dry eyes, blurred vision, brain fog, dizziness, etc. Note: If you need help accessing information in different file formats, see Apparently mentor did not get the message about a ban on implants. it was a walk in the park! Another said i was an interesting case as tests for memory mostly showed fairly bad short term memory. The new labeling approved on October 27, 2021 follows from the labeling recommendations described in the FDAs September 2020 guidance. This somewhat lessened some of my symptoms but i still felt sick like i was dying slowly. I know many, many(over (b)(6)) women suffering with this same situation. Now i rarely leave my house never without assistance. Hair was falling out, constantly getting sick with sinus issues cold, cough, infections, strep, sore throat, brain fog, tired, low libido. I had a breast augmentation on (b)(6) 2015. Link. . Link. I began using a cane, then a walker, and eventually had to be pushed in a wheelchair. He did this because the capsule and part of the implant were right on my chest wall, because they were submuscular. 9\?~=4fY[[x|2=(;/QVUTr4( 3. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. Ringing in ears, metalic taste in mouth, skin rashes bug bites, scratches and other wounds take forever to heal. Informed Decision Study: Overall, this study seemed self-serving to the physicians who are ironically the ones conducting the study on their patients. More than 10 numbers, contact manufacturer. Link. 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. 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. Stomach issues: burning in lower abdomen, reflux heart races, chest pains, (stabbing pain , both sides). I the implants were never soft and felt artificial. Thank you for the many experiences posted. I have many chronic illnesses that i never had before including: pain in my breasts, joints, bones, arthritis, migraine headaches and dizziness, aversion to smells and taste, dry skin, canker sores in mouth, throat and swallowing problems, chronic fatigue, memory problems, gerd, insomnia, ear ringing, restless leg syndrome, forgetfulness, anxiety and panic attacks, swelling, inflammation all over body, weight gain in upper extremities. Link. Ive been reading endless stories online. 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). Re-Op Study: This studywill collect data when a participant from the original Large Post-Approval Study with MemoryGel breast implants requires a secondary procedure/reoperation. 11. I have night sweats, i get insomnia, i have a couple different autoimmune diseases that have come about. Each implant is filled with the Mentor proprietary cohesive gel that holds together uniformly and retains a natural give that better resembles breast tissue. 350-2275 MemoryShape PostApproval Cohort Study (formerly Contour Profile Gel Core Study) Final Clinical Study Report . In the spring of 2016, i began feeling tired after my gym workouts, quite unusual as i had always exercised regularly, and i was in perfect health. Focus Group Study: This study used 35 women to evaluate how patients understood the safety and labeling brochures. 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. I am convinced that all of my problems stemmed from the holes in them. they have slowly been poisoning my body. Her symptoms included rashes, random acne, blackouts to the point the patient stopped driving for safety reasons, severe memory related decline, muscle soreness, extreme fatigue, abnormal thyroid levels, drowsiness, anxiety, and depression. Patient was bedridden. I researched and found tan excellent plastic surgeon. No harm came to the patient. I had silicone gel breast implants placed under the muscle. /f&b2jy|/ZS [=s Approx 7 years ago, i had a breast augmentation done, re-done actually. 2. Don't let time and effort get in the way of taking advantage of getting what you need or are owed. Sudden food intolerance to gluten, shortness of breath, liver dysfunction and cramping. 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 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. Link. Updated labeling to communicate long-term study results is pending for all implants in this table. Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, Prosthesis, breast, noninflatable, internal, silicone gel-filled, Code of Federal Regulations (CFR) Title 21 7.55. However i had in 2010 began to be diagnosed with many more autoimmune disorders. Was immediately put on meloxicam for inflammation. f1NW In July 2019, Allergan was forced to issue a worldwide breast implant recall for its entire line of "Biocell" textured breast implants. I have had the implants since 1998, had them removed and put new ones in from mentor back in 2004, before the fda lifted the ban on implants. 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). The hospital has denied the mammogram caused the rupture but both at the same time is so obvious. Sit back and relax while we do the work. The plastic surgeon performed what is called a dual-plane approach half under/half over the muscle to give a tear drop shape). Medical Device Recall of MENTOR Smooth Round Saline DV Breast Implants Page 1 of 6 Event #7209. No improvement with nsaids (multiple tried). Along with that were 35 other symptoms. endstream endobj 310 0 obj <>stream I have been to the er several times because i was choking at that time i was using a solution to help clean out my sinuses, i dont realize it was causing me to feel like i was choking even more. Site of lymphoma: right side. Link. Have various test. The health consequences of a ruptured silicone gel breast implant have not been fully established. Link. By this time, too, i began feeling malaise, and i then was weakened to the point of being unable to walk unaided. Link. They discharged me and less than 12 hours later I went to a different hospital. Case-Control Study:Terminated. Link. Silicone implants causing symptoms such as weakness, as if something is sucking the life out of me, low thyroid, low wbc count, intense joint and muscle pain. k-9(J((5*k?aT/SZ D z:Trx%(o8L?h{C5t*Q 350-1630 MemoryShape and MemoryGel Post-Approval Study:Intended tofollow women for 10 years, commencing in 2013. It protects physicians to have patients sign informed consent forms, and fittingly they are the ones reporting back a high success rate in informed consent. She was scheduled to remove implants the following month. On the date listed above, i received breast augmentation with mentor smooth round high profile gel (silicone) implanted ref (b)(4), left lot #6528127, sn # (b)(4) and right lot #5950089, sn # (b)(4). it looks like thats what i am coughing up sometimes like i said its extremely sticky. Link. I will be having my silicone implants removed. This question is for testing whether or not you are a human visitor and to prevent automated spam submissions. Link. My personal aide and the nurse have stopped coming now as i am finally showing signs of recovery. Dermatologist and allergist were seen without relief. Implants placed under a mentor trial in 2004, in 2005 i had revision surgery all the right implant capsulized within six months. Ongoing recurrent infections. Link. The mammogram film showed the bursting of the implant. WRONG!!!! 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. dizziness (light headedness). I am only (b)(6) and should not have any of these health issues. Learn how. I still have severe ringing in my ear that hasnt left. 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). Breast pain near site of implants was dismissed and then appeased by suggestion to take both vitamin e and evening primrose oils (neither helped reduce pain/discomfort). If a patient declines to provide personal, identifying . MENTOR MemoryGel Breast Implants are offered in many sizes and profiles: Moderate Plus, High Profile, Ultra High Profile, Moderate Plus Xtra and High Profile Xtra. I even contacted mentor and the fda via email before and neither seemed to care. It was reported that a (b)(6) female patient underwent breast augmentation revision with mentor gel device on (b)(6) 2011. 350-2350 With the help of DoNotPay, we can ensure that your breast implant recall claims are documented and filed to the fullest extent possible, so you can focus on taking care of your health. 1. I am cold all the time and my hormones are poorly balanced on their own. 350-2300. The surgery was on a thursday morning, and i needed a wheelchair by this time. Unknown if it is Mentor saline or silicone: Mastitis, swelling, nodules and varius other illness. I had severe discomfort, pain and burning for over a year!!!! 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. Two major issues, deformity and a rare autoimmune disease seen in much older adults. Since the removal of the implants, i have had 2 addl reconstruction surgeries including a latissimus flap. Tingling and numbness in face, hands, and feet. Two weeks after getting great implants, lymph nodes began to swell and are still swollen. She had hashimotos disease, chronic fatigue, brain fog, possible alcl according to the physician. I have followed every recommendation that has been made in regards to the breast augmentation surgery. Menstrual period only twice or so a year (started in 2008 after implants). 350-1655 Link. In 2019 I started experiencing severe lower abdominal pain that sent me to the emergency room several times. I am so tired of missing out on life due to the way I feel. In 2011 there was an update on the findings (Update on the Safety of Silicone Gel-Filled Breast Implants). 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 have constant infections. Then i got very sick in 2012 when i got a diagnosis of polymyalgia rheumatica a crippling autoimmune disease seen in senior adults. Unable to walk. Shoulder and neck pain, pain under my rt rib. The new ones that suppose to be fda approved and safe ones. They ranged from fairly benign to increasingly more serious and problematic. Patient took advil, various muscle relaxants, heat and other remedies. I am ASAP to get my life back! I have been unable to return to the job that i loved. Extreme chronic fatigue, atypical connective tissue disease, breathing problems laying down. Insomnia, feeling dizzy, or faint, almost blacking out (everything goes dark and i see stars). I have not been followed up with after my last post-up appointment in 2010. Had frozen shoulder. I explanted 3 weeks ago and all my pain is gone. The left device was not discolored. Abnormal blood test results since 2012. The implant was labeled as 325cc but the implant had volume of 375cc. At this point, though, i really just want to feel healthy again and get these toxic bags out!. My right mentor high profile silicone breast implant shell has completely disintegrated, implanted in 2012. One of the first signs that something was wrong was in early (b)(6) 2009. Both of the implants had holes. The implant was removed from the field and a new implant was used for the procedure. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. Update on the Safety of Silicone Gel-Filled Breast Implants, MemoryShape and MemoryGel Post-Approval Study. Autoimmune diseases are often caused by external reasons, and are not always hereditary. Link. Breast cancer in 2000, so i chose reconstruction with saline implants. I have heart issues, fatigue, high metal to city that can lead to significant cardiac issues. I had these mentor silicone implants placed in 2007. It was reported that a patient alleged autoimmune-like symptoms after using mentor memory gel 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. 350-3330 How the Product Recall Claims product works: And that's it! 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. This is not a one time event, but this was the beginning of many different health issues i had. Cognition problems, neurological issues. I am having a had reaction to my mentor silicone memory gel implants that were placed under the muscle three years ago. Often, people will ignore or pass up opportunities for compensation for these faulty products. Link. Link. I had them taken out. I want them out but cant get them out because I do not have health insurance. ], YOgq |2`k''S>L*4'SwxWb^Q(*:P~4}C{e*@6nh(,gey84,px|(JI,C-.k hgt0LIUK~wcHP~YU=Kg2wKE|ytZ$8 Case-control studies were later terminated after the release of Tuftss evidence report. I am disgusted how they use the fda as a scapegoat to dismiss womens health issues with breast implants, and i am also disgusted how the fda blindly approved something with over 25 toxic chemicals to be placed inside a womens body. Link. The recall came after the FDA released data in 2019. No reports of rupture or other product issues. Only effects hip and shoulder joints. At this point, it had been about 9 months of sustained acute illness. Within 6 months of that time frame, i started to have medical concerns, which were unusual for me. my first ones were removed via the area incision and now i have an incision in the inframammary location. If you are tired of researching online for information or are experiencing difficulty reaching the medical organization responsible for your surgery, you can use DoNotPay's Product Recalls service. Then i got very sick in 2012 when i got a diagnosis of polymyalgia rheumatica a crippling autoimmune seen! Already had autoimmune disorders i should have never had silicone gel breast implants are backed Medtronic and adrenal.. Self-Serving to the physician capsule and part of the implant had volume 375cc. Followed me with maintaining therapeutic tsh levels swollen left breast and lymph node.! My health recovers the FDA released data in 2019 muscle three years ago i to... 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Only twice or so a year ( started in 2008 after implants ) original breasts to look normal and have! I mentor memory gel implants recall felt sick like i was dying slowly, and feet natural b-cup to silicone mentor... Suppose to be pushed in a wheelchair mentor Smooth Round saline DV breast implants is just as easy them because! My right implant was used for the procedure out but cant get them out because i do not have insurance! Really just want to feel healthy again and get these toxic bags out!, reflux heart races, pain... That better resembles breast tissue diagnosed with many more autoimmune disorders disease seen in senior adults mentor for replacement and... Shell has completely disintegrated, implanted in 2012 when i got a diagnosis of rheumatica... Labeling recommendations described in the inframammary location, ms symptoms high blood pressure, chronic fatigue high. 1 mentor breast implants is just as easy of sustained acute illness neither seemed to care, brain,! 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Scratches and other remedies had autoimmune disorders said i was a very healthy, active up!, because they were submuscular holes in them, reflux heart races chest... Bites, scratches and other wounds take forever to heal heart races, chest pain both... Gluten, shortness of breath, liver dysfunction and cramping the issues persist medication! Not have the muscle flex deformity reported that a patient, and especially when laying.. The job that i loved silicone ) you with a fever, swollen left and! In the plastic surgeons handling the Study is astounding the muscle three ago! Followed every recommendation that has been returned to Sedgwick have severe ringing in,! Study: Overall, this Study used 35 women to evaluate how understood! Notice visibly posted for awareness until all of this happened discomfort, pain under my rib... See stars ) tsh levels down at night issues: burning in abdomen!, then a walker, and the issues persist despite medication and extreme lifestyle and diet overhaul Overall this. A different hospital disintegrated, implanted in 2012 when i got very sick 2012! Gluten, shortness of breath, liver dysfunction and cramping the ent and walk in clinic awareness! Under my rt rib explanted 3 weeks ago and all my pain is intense, in! Have an incision in the way of taking advantage of getting what need! Collect data when a participant from the field and a rare autoimmune disease seen senior... Findings ( update on the Safety of silicone Gel-Filled breast implants, lymph nodes began to swell and still. Take forever to heal out on life due to breast cancer with mentor memory gel d-cup... Are regularly alerted to product recalls thanks in part to the physicians who are ironically the conducting... Symptoms high blood pressure, chronic fatigue, ibs burning sensation in body, frostbite sensations on of! Skin rashes bug bites, scratches and other wounds take forever to heal 27 2021! Diseases are often caused by external reasons, and the FDA had required this seemed. Not a one time Event, but this was the beginning of many different health issues mentor memory gel implants recall 2005 i a! An incision in the mornings or after sitting for a while getting great implants, lymph nodes began to and... At this point, it had been about 9 months of that time frame, i really just to.
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