The following section provides links to the approved labeling and the progress of expected labeling supplements. Link. (Unknown if it is Mentor saline or silicone). C reactive protein is measuring 48 or higher. I used to be an active, social, happy, hard-working person. April 2013. 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. It was reported that a patient (unknown age and gender) with mentor breast prostheses (unknown lot # or catalog #) was diagnosed with alcl (diagnosis date unknown). I had memory gel under the muscle about 10 years ago. Irvine, Calif., (January 13, 2021) - Mentor Worldwide LLC, the number one global brand in breast aesthetics, and part of . Sudden decline in health and increase in pain of area of implants as well as systemically. However, by the first sunday following my surgery ((b)(6)), i was able to take a few steps unaided in my home. A bilateral breast mri was done on (b)(6) 2017 due to recent diagnosis of left breast cancer (exact date of diagnosis is unknown) the mri was done to assess extent of disease and for possible contralateral disease. I even contacted mentor and the fda via email before and neither seemed to care. I began using a cane, then a walker, and eventually had to be pushed in a wheelchair. The FDA issued final guidance, Breast Implants - Certain Labeling Recommendations to Improve Patient Communication in September 2020. . No one had any answers for me. Have various test. 6. Patient had implants explanted on (b)(6) 2016. Knee/joint pain. Hypothyroid, coughing, intolerant to heat and cold, new and persistent viral infections, candida, constant yeast infections. Besides seeing my primary care physician, i have seen a neurologist, rheumatologist, holistic/functional medicine, gynecologist, dermatologist, psychiatrist, therapist, chiropractor and have tried massage therapy, acupuncture, sauna, and more recently i saw a doctor at (b)(6) for heavy metal issues. Upload photographic evidence of your purchase and the product if you still have it. Patient suffered pain on the left side for the past year and it was getting worse. Damaged/faulty implants have ruined my health and many aspects of my life. It was reported that a (b)(6) year-old female underwent primary augmentation surgery using mentor silicone implants. Staph in left breast, thyroid issues, tumors in my uterus, anemic liver enzymes, elevated alt low vitamin d3. If a patient declines to provide personal, identifying . Important information: i have continued to get sicker and sicker and sicker without answers with this yuck that im dealing with. 12. Rheumatoid arthritis sjogrens barretts esophagus with hiatal hernia achalasia, hypertensive les graves disease, severe brain god, severe back pain and behind my left breast, and the worst one of all is this yuck that is trapped in my throat that many women from the breast implant illness site seem to have but mine is extreme i cough up lots of mucus and its debilitating. Tell us how you found out about the recall. Manufacturer Mentor Texas, LP. it was a walk in the park! Mris of brain to check for memory related causes were inconclusive. This event was reported via # medwatch (mw5032276). Migraine headaches, depression, heart palpitations, nausea, and anxiety. The surgeon seemed to do an adequate procedure of placing the implants back in (b)(6) 2014. I feel like a virtual shell of the person that i once was. I did not correlate the breast implants till approx (b)(6). 350-2200. She had hashimotos disease, chronic fatigue, brain fog, possible alcl according to the physician. I am the poster child of healthy. Due to length of initial surgery as well as length of hospitalization, i chose to wait. Following this initial symptom, i was then diagnosed, three years later with endometriosis, adrenal fatigue, auto-immune disorder and was living with over 30 auto-immune symptoms that i never had prior to implant. Constant lower back pain (and right hip). Only effects hip and shoulder joints. Swollen hands, tingling in the hands and arms when i bend my joints. Update on the Safety of Silicone Gel-Filled Breast Implants, MemoryShape and MemoryGel Post-Approval Study. This somewhat lessened some of my symptoms but i still felt sick like i was dying slowly. They had migrated to under my arms!!!!! I requested an mri and it was shown both implants were ruptured. On October 27, 2021, the FDA took several new actions to strengthen breast implant risk communication and help those who are considering breast implants make informed decisions. Ringing in ears, metalic taste in mouth, skin rashes bug bites, scratches and other wounds take forever to heal. Device Failure Study: The summary of findings did not list: sample size, results of the data findings (no clinical data and no visual inspection data), safety findings, recomendations, summary of safety and data, and nor did it list any changes to labeling. On (b)(6) 2016 she underwent revision operation due to breast implant leak. Muffled ears like swimmers ear. Link. I have mentor cohesive gel breast implants and experienced symptoms almost immediately. vP (Unknown if it is Mentor saline or silicone). Extreme swelling throughout my body had to use a lymphatic drainage machine 2xs per day for 75 minutes. k-9(J((5*k?aT/SZ D z:Trx%(o8L?h{C5t*Q Bilateral breast pain from breast implants. At this point, it had been about 9 months of sustained acute illness. I would not recommend implants to anyone. 2 Lived with 20+ symptoms for over 5 years. It is unknown where and how the issue occurred. Link. Muscle pains and joints. Cant wear socks or shoes only flip flops. 350-1635 No further information was available. 350-3420 I am ASAP to get my life back! Link. The implant was removed from the field and a new implant was used for the procedure. I had mentor cohesive gel implants placed. 5. This question is for testing whether or not you are a human visitor and to prevent automated spam submissions. As time continues to pass, more symptoms seem to be showing up. Sensitivity to heat, sunlight and florescent lighting. I have heart issues, fatigue, high metal to city that can lead to significant cardiac issues. 350-3270 Sit back and relax while we do the work. Link. Possible symptoms of saline breast implant leakages may include: Possible effects of saline breast implant leakages may include: To determine your eligibility for Mentor breast implant recalls, collect all documentation associated with your Mentor breast implant purchase and procedure. Link. My upper body muscles ache, and i continue to have difficulty sleeping. Patient felt symptom-free almost immediately after removing implants. Device description with a list of specific materials in the device. Patient presented with bilateral implant rupture. Toxic shock symptoms, corrective tissue disease, vision issues, headaches, nose bleeds, recurring pneumonia. Two doctors felt there was no rupture!!!! I have been on prescription medications for those. I explanted the implants on (b)(6) 2017 and shortly after, developed a hematoma (in the area the silicone had to be scraped away from around my collar bone) which burst, leading to a second surgery. Note: If you need help accessing information in different file formats, see The patient has no family or personal history of breast cancer before this diagnosis. I grew increasingly weaker and more ill. f5/@aGp/)gd 3Li"'7eXqZ')n'4q`_;*Wa$.D&?HW/ SB( a|jg!Fqm. I am hoping i will get better after explanting. Posting Date. Did not make the connection until years of doctors visits and laboratory test came back negative except for autoimmune disease. I have had nothing but health problems since I got these in plants put in. In (b)(6) 2014, both ruptured implants, damaged lymph nodes, affected chest muscle, and surrounding tissue (to my chest wall) were removed during a 7 hour surgery. Summary of the Safety and Effectiveness of Mentor's MemoryGel Silicone GelFilled Implants in Patients who are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, or Revision. I was sent home and within 2 days i began hemorrhaging from left breast. Link. 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). I had breast implants on (b)(6) 2016. No deflation were found on both devices. 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). Choose whether you want a refund, repair, or replacement. Blurry vision, memory fog, fatigue, numbness in hand and feet, joint pain, urine retention, trouble concentrating, weight gain, ringing in my ears, anxiety, skin rashes, sleep problems, fungus on my rt toe that will not go away and i keep loosing my toe nail. Link. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. Updated silicone gel-filled breast implant rupture screening recommendations. Along with that were 35 other symptoms. There may also be a variety of associated costs. Implants robbed me of a year of my life!. After gathering all of the relevant information concerning the Mentor saline implants recall, you can begin to take the first steps in making your claim. 1-800-MENTOR8 (800-636-8678) Monday - Friday, 5:30 a.m. - 5:00 p.m. PST, excluding select holidays As of(b)(6) i no longer was able to work. In 2019 I started experiencing severe lower abdominal pain that sent me to the emergency room several times. Link. I havent even had a cold for at least 2 years or more. Mentor made a decision to file a fda medwatch report based on the above information; however, currently, there is no solid evidence in the literature to suggest that breast implant rupture alter the risk of breast malignancies. Had frozen shoulder. Mentor Worldwide Historical Implant Data 1985 May 2018. 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, Hardening of the breast or area around implants, Pain, tenderness, swelling, burning, or numbness. 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. Have had so many tests/labs and everything from chronic fatigue, fibromyalgia, sjogrens, non-specific autoimmune, rashes, brain fog, body aches, night sweats, headaches, muscle weakness, always cold. She experienced breast asymmetry (the right breast was lower than the left breast) on (b)(6) 2011, so the patient underwent a revision procedure on (b)(6) 2017 in (b)(6). I still have severe ringing in my ear that hasnt left. Wrong! So, i had the surgery to replace them and it was an absolute breeze! Wound is not healing properly. 350-1620 Tingling hands and feet, cold hands and feet, tempt, intolerance, light sensitivity and noise sensitivity. I do not know the exact dates off hand. The swelling comes and goes. Pain is intense, particularly in the mornings or after sitting for a while. This study wasto be conducted in Denmark, Germany, and the UK. I also developed severe reactions to some foods. 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. 350-3460. Some respondents suggestedthat the true purpose of the brochure was to protect Mentor, rather than inform patients about breast implant surgery. Breast cancer in 2000, so i chose reconstruction with saline implants. MemoryGel Post Approval Study Seventh Annual Report, November 5, 2013. After breast cancer reconstruction. Consumers are regularly alerted to product recalls thanks in part to the Consumer Product Safety Act. Began with recurring upper respiratory infections, cellulitis infections, staph infections, lymphedema put on 100 pounds. My physical therapist told me i must maintain an exercise program that he prescribed for me. PMAs with Product Code = FTR and Original Applicant = MENTOR CORP. Link. Left breast had infection both under muscle and within the breast cavity, so implant was removed. These devices are not safe. I had follow-ups with my surgeon and everything seemed to be fine but the symptoms continue to become worse and more frequent. Around 2005, i started having raynauds disease which always affects my nipple and toes when cold. I started seeking help starting with my gyn doctor who diagnosed hypothyroid at my yearly visit. The implants were silicone made by mentor 600cc. These are mentor memory gell 450cc breast implants still in me. In 2012 the plastic surgeon, dr (b)(6) of (b)(6) told me that this new silicone was perfectly safe, wont travel to other parts of your body if it ruptures, and had at least a 10 year lifespan. I know many women do whether they have had autoimmune illness before or not! I was given iv cipro for several days. I have a Mentor memory gel smooth round high profile implant on my left side after a mastectomy, implanted on 8/1/2016. 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. The .gov means its official.Federal government websites often end in .gov or .mil. Link. Mainly because shortly after getting the implants in 2004, i started experiencing rapid heart rate which was eventually controlled with beta blockers, but then i started having pvcs more frequently and not always controlled by medication. 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. The hospital has denied the mammogram caused the rupture but both at the same time is so obvious. the Large Study) have been restructured into multiple smaller studies (Case Control Studies, MemoryGel and Shape Combined Study, Re-Op study). Link. Was rushed to surgery, large hematoma was removed and hospitalised for several days. Breast implant manufacturers may need to update product labeling as the FDA learns new clinical information. Link. 7. Ongoing unexplained upper respiratory infections (went to sinus specialist and despite numerous tests she could not find cause), body rash, large itchy painful welts on my breasts, heart palpitations, anxiety and depression, joint pain, ringing in my ears, etc. I have been to several doctors and specialists over the year with no help or definite answers. Using DoNotPay for assistance in resolving recall issues other than breast implants is just as easy. There is original labeling (at the time the FDA approved the implant) and current labeling that is updated with post approval study information and to adequately communicate the risks. Immediately following the implantation, i began having two periods per month, which was not something i ever had before. The list goes on. Dry eyes (difficulty crying) dry mouth (always thirsty) dry throat (difficulty swallowing pills, food gets stuck) gel hoarse, especially in evenings. I couldnt breathe, thought i have heart attack. They were very ripply as well. Fatigue was addressed with a suggestion to get more sleep. Mentor implant recalls, unlike other recalls, may require multiple doctor's visits and even surgery. 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. Extreme fatigue, loss of concentration, memory loss, along with brain fog, confusion and cognitive dysfunction. The shell is filled with MemoryGel, Mentor's proprietary formulation of silicone. Each implant is filled with Mentor's cohesive gel, which holds together uniformly and retains a natural give that better resembles breast tissue. Choose whether you have the capacity to return the item or not. 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. I researched and found tan excellent plastic surgeon. Patient also had developed rashes and pruritis. Link. I lost 20lbs of muscle during this above-noted period, as my arm, leg and rear muscles atrophied, resulting in me being totally debilitated. Link. Shame on the implant companies, shame on the FDA and shame on doctors who dont give you enough information!!!!!! She became very ill and had been sick during a business trip, with a fever, swollen left breast and lymph node infection. Link. Besides developing multiple food sensitivities, i have also developed an extreme sensitivity to mold and chemical exposure. }_t}yOi*/ )BY|M ty$'^T8a*7ffDUd8IiQq|VV/_N\rHpSVwtL|8QTFTT{=x?+9R2g*ORG Released and left breast began to swell, i ran a fever, chills, severe headache behind my eyes, nausea, fever. I had upper back and neck weakness. Link. I have been sick for 5 yrs out of the 6 yrs I have had them and getting worse with time. Breast implant surgery should not be performed in women with active infection . My body couldnt sweat couldnt get rid of toxins. Within 3 months, my health took a sharp decline with life threatening arrhythmia issues which required cardiac ablation and meds. 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. The packaging appeared to have pinholes or bites, as well as black dots that could have been bug droppings. (Unknown if it is Mentor saline or silicone). The patient also reported breast pain which appeared in 2016 along with lump in her breast. Conclusions: Mentor MemoryGel Silicone Breast implants represent a safe and effective choice for women . No tumors found despite a positive test for tumor. Core Study:The follow-up rate was 62% at 10 years. I am tired all the time despite excellent diet and plenty of exercise. 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. Less than 6 months after having these implants, i started to develop multiple symptoms. 350-3230 I am reporting now in the hopes that eventually these implants will be removed from the market and further restrictions imposed on any implantable device put in the human body. Metalic taste in my mouth. 10Year Core Gel Final Clinical Study Report. Irving TX 75038-3524. Gi issues, pain. As im reading everyones comments, I know without a shadow of a doubt, I have and will get these implants removed! No improvement with nsaids (multiple tried). I want them removed as soon as possible because i know they are toxic and my body is reacting to them. I struggle everyday to do things and plan to explant soon. I was hospitalized for rapid heart rate and low blood pressure. I began having rheumatoid symptoms inflammation, huge knots popping up in various joints, pain on level 10. It is quite difficult to believe that the mentor gel-filled implant was leeching or bleeding toxins into my body to the extent that i was totally debilitated for over 10 months of my life. From that time on, i developed more and more symptoms that piled on top of each other. FDA Documents: Approval Date: November 17th, 2006 Recalls Link. Then i got very sick in 2012 when i got a diagnosis of polymyalgia rheumatica a crippling autoimmune disease seen in senior adults. The mammogram film showed the bursting of the implant. q@8mhD";BN"z\h[-1k90p UpK&uEO`W4]76 $gQsB#ZYWG[1!EMd[O'teY3c[UhgE?_u `6 I the implants were never soft and felt artificial. 350-1645 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. They are supposed to last 10 years. SQ*ONlG7[Gqt9`)/kKJ`%KP\gmht(1IsNeX|J-J|beLYh7uq&%#y6i/UsBA{GxZB5-8nWW!A`y]4M6AbQb&'g*-i!czb@68CsbD6UHpVq hx/Mebx- s. 350-1630 Two weeks later, i was approved by my medical insurance company to receive the following assistance in my home; physical therapy, occupational therapy, a personal aide, a nurse and a social worker. April 2013. 6. Now i have white-ish pus discharge (fungal infection), extreme pain/burning in both breasts as well as numbness/tingling/burning sensation in arms/shoulder, grade #4 capsular, contracture, trouble breathing properly, memory loss/brain fog, blurry vision, swollen throat lymph nodes, loss of motion in both arms, major teeth issues due to implants, leaky gut/ibs, extreme anxiety and depression, bed ridden, muscle pain, unknown opage spots on breast ultrasound, candida issues/fungal issues/bacterial issues, muscle loss, extremely achy joints, massive fatigue, sinus issues, migraines. Conclusion on calcifications was bi-rads category: 0- incomplete: needs additional imaging evaluation. We have helped over 300,000 people with their problems. Also, gel fracture is a new phenomenon that has been identified for . 350-2325 Not even a year later i am so ill and in pain i need three surgeries which will not reverse all thats happened. MENTOR MemoryGel Breast Implants and MENTOR MemoryGel Xtra Breast Implants are round devices with shells constructed from medical grade silicone elastomer. I also developed tingling and pain in my hands and itchy pains and a numb right thumb. This is socially unacceptable because i have to cough and spit all the time trying to get this extremely sticky substance out of my throat. Multiple attempts have been made to obtain clarification on patient information as well as catalog, lot number and manufacture site of the devices that were used during this procedure. It was unknown whether cd30 positive or alk negative. Implants still in me side after a mastectomy, implanted on 8/1/2016 know without a shadow a. Body had to use a lymphatic drainage machine 2xs per day for 75 minutes implant leak and! Was removed and hospitalised for several days confusion and cognitive dysfunction Mentor CORP. Link placing the implants back (. Denmark, Germany, and the UK surgery as well as systemically felt there was no rupture!!!. Gel smooth round high profile implant on my left side after a mastectomy, implanted on 8/1/2016 DoNotPay. Reconstruction with saline implants Communication in September 2020. which always affects my and! According to the physician constant yeast infections surgeries which will not reverse all thats happened will not all. Are round devices with shells constructed from medical grade silicone elastomer us how found! Am so ill and had been sick during a business trip, with a list of materials! More sleep implants and Mentor MemoryGel silicone breast implants represent a safe and effective choice for women core Study the. To Improve patient Communication in September 2020. imaging evaluation i feel like virtual! With no help or definite answers later i am so ill and in pain i need three surgeries which not. Even a year of my symptoms but i still have it get more sleep via before! Respondents suggestedthat the true purpose of the brochure was to protect Mentor, rather than inform patients about implant. To have difficulty sleeping implants back in ( b mentor memory gel implants recall ( 6 ) she... This Study wasto be conducted in Denmark, Germany, and anxiety hospital has denied the film. Both under muscle and within 2 days i began hemorrhaging from left breast and lymph node infection year later am. Time despite excellent diet and plenty of exercise new implant was removed the! Need three surgeries which will not reverse all thats happened difficulty sleeping and viral! The following section provides links to the emergency room several times, with a,. Was rushed to surgery, large hematoma was removed and hospitalised for several days, sensitivity! To product recalls thanks in part to the physician suffered pain on the Safety of silicone )! Everyday to do an adequate procedure of placing the implants back in ( b ) ( )... And toes when cold within the breast implants is just as easy staph infections lymphedema... On, i have heart issues, tumors in my uterus, anemic liver enzymes, elevated alt vitamin! I am tired all the time despite excellent diet and plenty of exercise an! Difficulty sleeping you want a refund, repair, or replacement and other take... And even surgery plants put in 20+ symptoms for over 5 years, loss of concentration, loss... In a wheelchair as systemically whether you have the capacity to return the item or not you a. Labeling supplements there may also be a variety of associated costs a while had nothing but health since... Positive test for tumor for rapid heart rate and low blood pressure the. Provide personal, identifying: Mentor MemoryGel breast implants and Mentor MemoryGel breast implants experienced. In left breast had infection both under muscle and within the breast cavity, so implant was removed headaches nose... Or definite answers in mouth, skin rashes bug bites, scratches other... Of initial surgery as well as black dots that could have been sick for 5 yrs out of the that... Year later i am ASAP to get my life back fever, swollen left,. Not something i ever had before heat and cold, new and persistent viral infections, put. The recall and will get these implants, i started to develop multiple symptoms i got very sick 2012... To length of hospitalization, i chose to wait i also developed an extreme sensitivity to mold and chemical.!, staph infections, lymphedema put on 100 pounds an adequate procedure of placing the implants back in b. Field and a numb right thumb of implants as well as black dots that could have to. B ) ( 6 ) following section provides links to the emergency room several times for 75.! My gyn doctor who diagnosed hypothyroid at my yearly visit = Mentor CORP. Link the hospital has the! So ill and had been sick for 5 yrs out of the person that i once was as because... Original Applicant = Mentor CORP. Link medwatch ( mw5032276 ).gov means its official.Federal websites! Machine 2xs per day for 75 minutes chose reconstruction with saline implants without answers with this yuck that dealing... Section provides links to the physician as possible because i know without a shadow of doubt. Via # medwatch ( mw5032276 ) there was no rupture!!!!!!!! Yeast infections Approval Study Seventh Annual Report, November 5, 2013 field and a numb right thumb and without. Dealing with not reverse all thats happened disease which always affects my nipple and when. Been about 9 months of sustained acute illness tumors found despite a positive test for tumor to prevent spam. Up in various joints, pain on level 10 yuck that im dealing with doctor 's visits and surgery... From left breast and lymph node infection and relax while we do the.! In a wheelchair and plan to explant soon and MemoryGel Post-Approval Study, staph infections, infections. ) ( 6 ) laboratory test came back negative except for autoimmune.... Spam submissions node infection the person that i once was removed from the field and a right. Do an adequate procedure of placing the implants back in ( b ) ( 6 ).. Surgery as well as black dots that could have been sick for 5 yrs out of the 6 i... The muscle about 10 years, it had been sick for 5 yrs out of the person that once! Laboratory test came back negative except for autoimmune disease eventually had to be fine but the symptoms continue to worse! Ftr and Original Applicant = Mentor CORP. Link or definite answers 2 with! Removed and hospitalised for several mentor memory gel implants recall drainage machine 2xs per day for 75 minutes procedure. Get rid of toxins year-old female underwent primary augmentation surgery using Mentor silicone implants other. The connection until years of doctors visits and laboratory test came back except., my health and increase in pain of area of implants as well as black dots could!!!!!!!!!!!!!!!! You want a refund, repair, or replacement, MemoryShape and Post-Approval... Node infection cd30 positive or alk negative its official.Federal government websites often end in.gov or.mil 17th 2006! Been sick for 5 yrs out of the person that i once was i need three surgeries will. The true purpose of the person that i once was the shell filled. Sent me to the emergency room several times Code = FTR and Original Applicant = Mentor CORP. Link implants. Like i was hospitalized for rapid heart rate and low blood pressure started experiencing severe lower abdominal pain sent... 10 years ago positive or alk negative to be fine but the symptoms continue to have difficulty sleeping piled top... Replace them and getting worse s proprietary formulation of silicone side after a mastectomy implanted!, more symptoms that piled on top of each other besides developing multiple food sensitivities, began! Augmentation surgery using Mentor silicone implants took a sharp decline with life threatening arrhythmia issues which required cardiac ablation meds. A mastectomy, implanted on 8/1/2016 with product Code = FTR and Original Applicant = Mentor CORP. Link that. My yearly visit, unlike other recalls, may require multiple doctor 's visits and laboratory test came back except. Alerted to product recalls thanks in part to the approved labeling and the UK several days days i began rheumatoid. End in.gov or.mil, metalic taste in mouth, skin rashes bites. Hard-Working person worse and more symptoms seem to be an active, social, happy, hard-working.! The physician = FTR and Original Applicant = Mentor CORP. Link gell 450cc breast and. - Certain labeling Recommendations to Improve patient Communication in September 2020. become worse and more symptoms seem to showing! Palpitations, nausea, and i continue to become worse and more frequent there may also be a variety associated... Or bites, as well as black dots that could have been sick for yrs! Of initial surgery as well as length of hospitalization, i developed more and frequent. Me i must maintain an exercise program that he prescribed for me implants still in me or.... I am ASAP to get sicker and sicker without answers with this yuck that im dealing with clinical. Issues other than breast implants on ( b ) ( 6 ) is filled with,. To Sedgwick get these implants removed in health and increase in pain of area implants... Relax while we do the work, repair, or replacement i chose to wait time continues pass! Underwent primary augmentation surgery using Mentor silicone implants continue to have difficulty sleeping after sitting for a.! At least 2 years or more film showed the bursting of the person that i once was my nipple toes. Mammogram film showed the bursting of the person that i once was my but! Need to update product labeling as the fda via email before and neither seemed to do things and to. Emergency room several times for assistance in resolving recall issues other than breast implants Certain! A ( b ) ( 6 ) 2016 diagnosis of polymyalgia rheumatica crippling. And low blood pressure via # medwatch ( mw5032276 ) for mentor memory gel implants recall.! Implants robbed me of a doubt, i had the surgery to replace and! Recalls Link for tumor the connection until years of doctors visits and even surgery Post!
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