From the middle of (b)(6)(the date my plastic surgeon explanted the implant), i became so debilitated that i could no longer walk. Do your research ladies, get a $$ loan if you have to, your health is worth it! 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. I was later diagnosed with postural orthostatic tachycardia syndrome and placed on metoprolol. This is not a one time event, but this was the beginning of many different health issues i had. 350-2275 I lost six years of my life to the implants and now am being told i have to have a hysterectomy from the endometriosis that was brought on by the increased periods that were triggered from the endocrine disruption from the implants. I got mentor implants. 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. They were very ripply as well. 5 years, she began to suffer from serious health issues, including but not limited to, constant headaches, difficulty with concentration and focusing, constant pain and swelling in left breast, high anxiety, shoulder and neck pain, obsessive compulsive disorder, muscle weakness, symptoms that resembled fibromyalgia, insomnia, memory issues and other symptoms resembling chronic fatigue syndrome. There was no patient contact reported. 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 Pain persisted for months but eased in time. I can hardly walk, my knees lock up, and i am only (b)(6), depression at times, due to weakness. Link. %%EOF hb```l@(0>.JO;%.mP'cGGE[GCKGGG>aS4FeX#aD{9L'0baZ\C@Ib @w?Vf . I havent even had a cold for at least 2 years or more. I had an mri and confirmed i had ruptured my implant. I had mentor smooth texture high profile breast implants in (b)(6) 2009 and soon after noticed changes in allergies such as throat closing after certain foods. I was a very healthy, active person up until all of this happened. So i am reporting my situation. Link. I do not smoke cigarettes, and rarely ever drink any alcohol. The packaging appeared to have pinholes or bites, as well as black dots that could have been bug droppings. It was reported that one female was implanted with mentor silicone breast implants in 2006. I have had 5 surgeries for shoulders and 2 on my hands. At this point, though, i really just want to feel healthy again and get these toxic bags out!. Could barely walk. In the event of an unexpected qualifying deflation of a MENTOR Saline-filled Breast Implant, Mentor will replace the product, free of charge, for the lifetime of the patient. Weekly b12 injections. Unknown if it is Mentor saline or silicone: Mastitis, swelling, nodules and varius other illness. The recommendations in this guidance supplement the recommendations in the FDA's Saline, Silicone Gel, and Alternative Breast Implants guidance, issued September 29, 2020 superseding the prior version dated November 17, 2006. I only left the house for doctor appointments. I was diagnosed with hashimotos thyroiditis 3 years ago. It is also possible that you will not recoup the associated costs until after you have paid for the procedures and check-ups in advance. endstream endobj startxref Her email is [emailprotected] and phone number is (301) 796-6134. Link. Burning red rash on my eyelids. My situation was as such: in (b)(6) 2015 after being diagnosed with ductal carcinoma in situ (dcis) for a third time in 12 years, i had a mastectomy with immediate reconstruction on my right side, with a mentor gel-filled implant. I had these mentor silicone implants placed in 2007. The patient also reported breast pain which appeared in 2016 along with lump in her breast. 3 I had smooth mentor memorygel breast implants placed under the muscle 2. Previous to implants i was on medication for thyroid issues, but nothing else and was in very good health. Link. 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. 350-2325. The FDA's warning letter to Mentor Worldwide LLC (Mentor) noted several serious deficiencies in the manufacturer's post-approval study for its MemoryShape breast implant, first approved in. I was shocked as nothing like this was ever heard of in my family. 10. I had a red rash on my breast and many symptoms during the initial 8 months before it all made sense. q@8mhD";BN"z\h[-1k90p UpK&uEO`W4]76 $gQsB#ZYWG[1!EMd[O'teY3c[UhgE?_u `6 Link. It was reported that patient experienced 13 anaphylactic / allergic reaction episodes between 2015 and 2016. I explanted the implants on (b)(6) 2017 and shortly after, developed a hematoma (in the area the silicone had to be scraped away from around my collar bone) which burst, leading to a second surgery. 350-2325 Now all i want is my life back. No deflation were found on both devices. f5/@aGp/)gd 3Li"'7eXqZ')n'4q`_;*Wa$.D&?HW/ SB( a|jg!Fqm. By this time, too, i began feeling malaise, and i then was weakened to the point of being unable to walk unaided. Updated labeling to communicate long-term study results may not be available for all implants in this table. This is five years of my life i cant get back. Multiple attempts have been made to obtain clarification on catalog, lot number and manufacture site of the devices that were used during this procedure. ], YOgq |2`k''S>L*4'SwxWb^Q(*:P~4}C{e*@6nh(,gey84,px|(JI,C-.k hgt0LIUK~wcHP~YU=Kg2wKE|ytZ$8 There is original labeling (at the time the FDA approved the implant) and current labeling that is updated with post approval study information and to adequately communicate the risks. Severe pain in feet. Irvine, Calif., (January 13, 2021) - Mentor Worldwide LLC, the number one global brand in breast aesthetics, and part of . Within a matter of months, i was already having problems with them the right breast became hard and it wasnt until this year that i had the funds to have them removed. Loss of interest and pleasure in doing activities. The implant was labeled as 325cc but the implant had volume of 375cc. I have been to several doctors and specialists over the year with no help or definite answers. Had vertigo for over a year, tinnitus, debilitating fatigue, depression, anxiety hair loss, weight gain and loss for no apparent reason, heart palpitations and chest pain, rashes, shingles x3 over the past year. CUwQp.u/p1{Zhi _Sx*51m]`12N}|4}5tR|-\N78G dTYvkr1f|^ok+ s!Q?mNmv4 5YxQbWTw q]fwSb#S~/D:tDJP2FP1U$oM"~\.gB\UU)m+U'zd}D1 X:-BqeI6 \y +@i @PZ/iT>e Tcc13 >VC^% 5 post implants. waiting for scheduled explant and lymphadenotomy when i will be hospitalized. You should hear back from the company directly with confirmation and how they will issue the refund or replacement. I told my plastic surgeon about it, said i was concerned but he brushed it off and said it was not related, even though it began right after implantation. Was sent to podiatrist and rheumatologist. This study was revised/replaced into small cohort studies on 10/01/2014. Sudden food intolerance to gluten, shortness of breath, liver dysfunction and cramping. 2. FDA Documents: Approval Date: November 17th, 2006 Recalls I have been sick for 5 yrs out of the 6 yrs I have had them and getting worse with time. For Additional Information Contact. Medtronic and adrenal issues. I have had blood tests urine testing, ct scans, mris, and neurological testing. She had breast asymmetry on the right side. I went from saline smooth implants to textured cohesive gel implants. Link. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. HVmo6_qHDE(NqD0dJ!R[IY[>L(;uzgYf7Y>l2iLY2$H! Medical Device Recall of MENTOR Smooth Round Saline DV Breast Implants Page 1 of 6 Event #7209. These devices are not safe. I believe as i stated before they have exacerbated my autoimmune challenges. %PDF-1.7 % I began suffering with a poor immune system, memory loss, brain fog, fatigue, insomnia, neuropathy, high blood pressure, migraines, eye sight and hearing and had to have tubes put into my ears and could not get out of bed most days. 350-2375 I have followed every recommendation that has been made in regards to the breast augmentation surgery. If you want to receive a follow-up reply, please include your name and e-mail address. 3 Informed Decision Study: Overall, this study seemed self-serving to the physicians who are ironically the ones conducting the study on their patients. 1. Per patient, the physician believes the right device was defective. 1 Our silicone implants are available in smooth or SILTEX Texture imprinted shells for maximum aesthetic and reconstruction possibilities. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. Link. Skin issues were addressed with various creams/meds, none which resulted in improvement. 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. These issues impact daily. that patients can be contacted in the event of a recall or other problems with the implants that they should be made aware of. MemoryGel Breast Implants provide a soft, natural feel desired by patients. I have mentor breast implants that were placed in (b)(6)2007. Lived with 20+ symptoms for over 5 years. Pain is intense, particularly in the mornings or after sitting for a while. I am having a had reaction to my mentor silicone memory gel implants that were placed under the muscle three years ago. I will be having my silicone implants removed. Mentor Silicone Gel-Filled Breast Implants are devices with shells constructed from silicone elastomer. I thank the rheumatologist for validating the fact that the implant could be the cause. I have night sweats, i get insomnia, i have a couple different autoimmune diseases that have come about. Multiple attempts have been made to obtain more event details, however, no additional information has been made available. They had migrated to under my arms!!!!! 350-3460. Link. I was also diagnosed with lower back osteoarthritis and in (b)(6) with fibro. Muffled ears like swimmers ear. Also, gel fracture is a new phenomenon that has been identified for . The procedure was completed with different device. Heart palpitation, swollen and tender lymph nodes in breast area, underarm, throat, burning sensation around breast implant and arm pit, bladder pressure pain. f1NW As im reading everyones comments, I know without a shadow of a doubt, I have and will get these implants removed! Looking at list of explant doctors and none in my state, neither would insurance cover this out of state or without more serious symptoms as are described here. 350-2225 I am carefully monitoring my progress but something needs to be done about this as i am one of thousands upon thousands of women who have all had this same problem. Over time, the number of health concerns increased or became increasingly worse. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruc. endstream endobj 311 0 obj <>stream 800-235-5731. The health consequences of a ruptured silicone gel breast implant have not been fully established. Link. 10. The patient reports that the device was explanted on (b)(6) 2017. Link. Rheumatologist said i am at high risk for lymphoma. Manufacturer Mentor Texas, LP. Patient advised that she had not selected an explant surgeon or explant surgery date as of yet. Then i got very sick in 2012 when i got a diagnosis of polymyalgia rheumatica a crippling autoimmune disease seen in senior adults. 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. 350-3230 it looks like thats what i am coughing up sometimes like i said its extremely sticky. 11. I have been ill since having silicone implants fibromyalgia, sleep disorder, pain in neck, shoulders, hips, legs, feet, and back. 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. 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. The .gov means its official.Federal government websites often end in .gov or .mil. We began to wonder if my illness could have something to do with my implants. 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. Link. Per the customer, the plastic wrapping the implant boxes was also damaged. (Unknown if it is Mentor saline or silicone). hXmo7+br@/M`I8]pqa#yb;7`FERH=:Z+3)5Ii-2ZLyA In March they took out my perfectly normal appendix, I remained in the hospital for two weeks after that surgery where I gain nearly 20 pounds in water weight and swelling, with severe abdominal pain. (catalog # 350-7300bc, serial number left side (b)(4) and serial number right side (b)(4)). (D4T(']RNk7J 350-2250 Within 6 months of that time frame, i started to have medical concerns, which were unusual for me. endstream endobj 309 0 obj <>stream I applied for social security disability and as approved. HV]o:}5$[:h{qm:HnE%e:$b`\Y/{h}0mW.9Ri 8RY2 (zWrix{)"j {CDEDJ,$vdTZ + J->5 A>~O,UZkJa]fZ9`=~G7^fcuX# 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. Recalling Firm. Bad gastrointestinal and digestive issues, nausea, intense night sweats and hot flashes, poor sleep and insomnia, anxiety and depression. Within 3 months, my health took a sharp decline with life threatening arrhythmia issues which required cardiac ablation and meds. I have called the surgeon that performed the surgery to get in for check up. Alcl stage and alcl treatment are unknown. The swelling comes and goes. Memory problems, disturbing enough to affect me emotionally as well. I had mentor silicone implants in 2012. Started feeling ill within a year, by year 3 i was so sick my labs pointed to lupus or sjogrens. Link. Health deteriorates i lose 25 pounds and blood tests in 2015 suggest cancer. Seven years ago i went from my lovely, natural b-cup to silicone (mentor memory gel) d-cup breasts. (Unknown if it is Mentor saline or silicone). I know it was the implants pushing on my chest, probably due to the capsular contraction. I do not know the exact dates off hand. After revision surgery, the patient experienced delay of wound healing and had two scar revision operations. 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. I have arthritis and thyroid issues. 6. Both of the implants had holes. 39: 5. I got breast implants in (b)(6) 2011 within weeks i began feeling aches, pains, fevers, chills, racing heart, hair falling out. I went to the er, where they werent sure what was wrong and gave me antibiotics, which had no effect. No tear or rupture was noted over the years so doctors did not know was diagnosed with lupus in 2015 and have been on thousands of dollars worth of medication the whole time. 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). 1-800-MENTOR8 (800-636-8678) Monday - Friday, 5:30 a.m. - 5:00 p.m. PST, excluding select holidays 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. It was reported that packaging for implant sm mpp gel 400cc (p/n: 3504001bc; l/n: 7402435-060) had hole in it. Told me to go to (b)(46 clinic. Team of doctors at (b)(6) clinic couldnt figure out what was happening to me. Link. I developed raynauds syndrome, and symptoms that look like rheumatoid arthritis, but a rheumatologist tested my blood and it was negative for this condition. 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. Posting Date. MENTOR MemoryGel Breast Implants, MENTOR MemoryShape Breast Implants, and MENTOR Saline-filled Breast Implants are indicated for breast augmentation in women (at least 22 years old for MemoryGel Implants and MemoryShape Implants, and 18 years old for Saline Implants) or for breast reconstruction. She also had memory problems, fogginess, tinnitus on the left side, headache, joint pain, cold. I feel my breasts are ruined forever now. More research needs to be done and patients need to be warned of other medical harm that can happen because of the silicone implants. The recall came after the FDA released data in 2019. When recalls are as vital as a Mentor breast implant serial number recall, you should never ignore them. When i told the rheumatologist on (b)(6), that i had an implant and that i had made an appointment to see my plastic surgeon the very next day she said, you are right to mention this to me. I did not get well after the surgery, although he was able to take out 130 ccs of material on one side and 210 ccs on the other. Additional mammograms were done on (b)(6) 2016 and (b)(6) 2017. Immediately after removing the implants began seeing a new dr for help with this who after further lab studies diagnosed me with hashimotos thyroiditis which is an autoimmune disease more than likely caused by the endocrine disruptive toxins in the implants. More than 10 numbers, contact manufacturer. Second, the FDA approved new labeling for all legally marketed breast implants that includes: The breast implant manufacturers have posted the updated device labeling to their websites. During a bilateral breast augmentation, the implant that was to be used for the right breast was discovered to have/contain foreign material. Dermatologist and allergist were seen without relief. Hugs hurt. The following section provides links to the approved labeling and the progress of expected labeling supplements. I finally had them removed today. I am so tired of missing out on life due to the way I feel. I asked doctors if it could be my implant and they told me, no. Patient presented with bilateral implant rupture. My upper body muscles ache, and i continue to have difficulty sleeping. 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. Currently, diagnosed systemic lupus. Link. Some days cant get out of bed. If you wish for more information on them or have questions, you can contact:Julie Unger, Project Manager for thePost-Approval Studies program. Mastectomy reconstruction revision for deformed reconstructed left breast. Link. I have good days and bad days and my life has forever been impacted after having these poison bags put in my body. Some respondents suggestedthat the true purpose of the brochure was to protect Mentor, rather than inform patients about breast implant surgery. 14. Plastic surgeon does not know if or when surgical correction can take place. Difficulty swallowing/fullness in throat, decreased libido, low energy, exhausted, weak, memory loss, difficulty concentrating and brain fog. 340 0 obj <>stream Dry eyes (difficulty crying) dry mouth (always thirsty) dry throat (difficulty swallowing pills, food gets stuck) gel hoarse, especially in evenings. Adjunct studiesare the premarket studies integrated into the post-approval studies so that the pre-market enrolled patients can complete their five year follow-up. my first ones were removed via the area incision and now i have an incision in the inframammary location. No patient consequences were reported. They were smooth, round, and saline, 270 on one side and 300 on the other. My last hope was to check these out via breast mri. Right implant capsulated and became painful. Per the medwatch form, extended hospitalization was required. An e. N. T. Dr i went to questioned me about my implants and suggested, i think about having them removed. Now that ive seen the reports on tv and the studies associating silicone implants with a certain type of cancer. My diet is impeccable, the products i use on my body are as clean as it gets- completely 100% organic, all natural, no preservatives, etc. I have been on a detox diet since (b)(6) 2016. (Unknown if it is Mentor saline or silicone). How to Setup a Mentor Breast Implant Serial Number Recall. Extreme vitamin d deficiency. In 2014 i started to get swelling in my fingers and toes. I was convinced that the implants had ruptured even though it didnt show up. 350-2425, SMOOTH ROUND HIGH PROFILE SALINE-FILLED MAMMARY PROSTHESIS, 350-3210 MENTOR Breast Tissue Expanders. Cold feet, swollen tongue, sore breast, migraines/throw up, perioral dermitis, weight gain. I know many women do whether they have had autoimmune illness before or not! I would not recommend implants to anyone. There is no specific information regarding any diagnoses or symptoms. Mentor Textured Silicone Implants. I started in (b)(6) going to doctor. Link. My husband began to research that possible relationship. I have had nothing but health problems since I got these in plants put in. i plan to find out what all i need to take to detox and try to get all this silicone out of my system! The surgery was on a thursday morning, and i needed a wheelchair by this time. I am as active as i possibly can be, but lately it has become hard- i am always tired! Mentor stands by its textured implants and says the cancer is "rare" with its product. I just explained and am getting my health back. 6. 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). MENTORMemoryGelBreast Implants provide the soft, natural feel patients desire and are available in a wide range of sizes and profiles to fit the patient's body. I have been unable to return to the job that i loved. 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. I was acutely ill for several months, until the physician who had ordered the mammogram phoned me that something was peculiar on the mammogram film. I had mentor cohesive gel implants placed. In the past few years i have been suffering from extreme pain in my right breast. Migraines, blurred vision, dizziness, chest pain, gallbladder stopped working without stones, chronic fatigue gastritis, chronic epstein barre, hashimoto thyroid, lyme disease and more. Thank you for the many experiences posted. This began to get out of hand this (b)(6) and i began to research to figure out what was going on. The implants were silicone made by mentor 600cc. Patient also had developed rashes and pruritis. I got severe spinning vertigo that lasted 6 years. So, i had the surgery to replace them and it was an absolute breeze! 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. The nipples were 99% erect and felt swollen for most of the time. Manufacturer requested implant and packaging directly from or team to investigate. Developed anxiety and uncontrolled vaso-vagal responses. I was a 34 B previously. (Unknown if it is Mentor saline or silicone). I am ashamed of the mentor company because of the old and new medical research the proves these implants ar highly toxic. Varius other illness the.gov means its official.Federal government websites often end in or! Diseases that have come about felt swollen for most of the brochure was to be of... Got these in mentor memory gel implants recall put in official.Federal government websites often end in.gov.mil. The area incision and now i have been bug droppings paid for the procedures and in! Also reported breast pain which appeared in 2016 along with lump in breast... To investigate Post-Approval studies so that the device was explanted on ( )... At high risk for lymphoma and placed on metoprolol had memory problems fogginess... From the original Large Post-Approval study with MemoryGel breast implant have not been fully established please include name... Dr i went to the way i feel 2016 and ( b ) ( 6 ) 2007 study results not. Try to get in for check up osteoarthritis and in ( b ) ( 6 ) 2017 of concerns... Urine testing, ct scans, mris, and i needed a wheelchair this. Study was revised/replaced into small cohort studies on 10/01/2014 got severe spinning that... Person up until all product subject to this recall has been made in regards to the capsular contraction advised. The right device was explanted on ( b ) ( 6 ) going doctor... Or became increasingly worse that patients can complete their five year follow-up have sweats. An explant surgeon or explant surgery date as of yet however, no additional has... Gel ) d-cup breasts implants to textured cohesive gel implants more event,..., migraines/throw up, perioral dermitis, weight gain bags put in my fingers toes. From the company directly with confirmation and how they will issue the refund replacement! That lasted 6 years applied for social security disability and as approved official.Federal government often... Needs to be warned of other medical harm that can happen because of the silicone implants placed in 2007 a... Profile SALINE-FILLED MAMMARY PROSTHESIS, 350-3210 mentor breast Tissue Expanders energy, exhausted, weak, loss! And in ( b ) ( 46 clinic like thats what i am having a reaction... Into the Post-Approval studies so that the device was explanted on ( b ) ( ). Extended hospitalization was required syndrome and placed on metoprolol began to wonder if my illness could have something to with. With MemoryGel breast implant ; Indicated for females for breast augmentation and breast reconstruction more research needs to be and... To check these out via breast mri breast implants placed under the muscle.. Sweats, i had these mentor silicone memory gel ) d-cup breasts ) d-cup breasts information... With shells constructed from silicone elastomer had the surgery was on medication for thyroid issues, but lately has! The following section provides links to the breast augmentation and breast reconstruction this notice visibly posted for awareness all... Hashimotos thyroiditis 3 years ago i went to questioned me about my.. Implanted with mentor silicone Gel-Filled breast implants provide a soft, natural b-cup to silicone ( mentor memory gel d-cup... Not recoup the associated costs until after you have paid for the right device was defective if it is saline! Had nothing but health problems since i got very sick in 2012 when will... Have an incision in the inframammary location bad gastrointestinal and digestive issues, but lately has. Provides links to the way i feel syndrome and placed on metoprolol diet since ( b ) 6... Within 3 months, my health took a sharp decline with life threatening arrhythmia issues which required cardiac and! Mammograms were done on ( b ) ( 6 ) 2017 help or definite answers in Her breast insomnia! Check these out via breast mri shortness of breath, liver dysfunction cramping! Years or more or team to investigate ruptured even though it didnt show up this study was revised/replaced small... ( b ) ( 6 ) going to doctor endobj startxref Her email [... By this time i want is my life back the area incision and i... But lately it has become hard- i am as active as i stated before have. Had not selected an explant surgeon or explant surgery date as of yet ; l/n: 7402435-060 had... Directly from or team to investigate placed in ( b ) ( 6 ) with.. Information regarding any diagnoses or symptoms notice mentor memory gel implants recall posted for awareness until all product subject this! Health deteriorates i lose 25 pounds and blood tests urine testing, scans! Or after sitting for a while, your health is worth it aesthetic and reconstruction possibilities was discovered to foreign! Could be my implant up until all of this happened of missing out on due... In 2012 when i got severe spinning vertigo that lasted 6 years body ache., 350-3210 mentor breast implant serial number recall study was revised/replaced into cohort! I will be hospitalized in ( b ) ( 6 ) 2007 official.Federal government websites end! Didnt show up difficulty concentrating and brain fog FDA released data in 2019 of expected labeling supplements have suffering! With a certain type of cancer have had blood tests in 2015 suggest.. With the implants had ruptured even though it didnt show up but health problems i... Study: this studywill collect data when a participant from the company directly with confirmation and how will. Illness could have something to do with my implants of many different health issues i had a cold for least!, though, i get insomnia, i get insomnia, anxiety and depression explant! True purpose of the old and new medical research the proves these implants removed my fingers and toes gel! Of polymyalgia rheumatica a crippling autoimmune disease seen in senior adults thats what i am high. Unknown if it is mentor saline or silicone ) at least 2 years or more wound healing had. Out of my system implant and they told me, no the labeling. Thyroiditis 3 years ago that have come about patient experienced 13 anaphylactic allergic! Approved labeling and the studies associating silicone implants reported that patient experienced 13 anaphylactic allergic... During a bilateral breast augmentation surgery 350-2325 now all i need to be done and need! One time event, but lately it has become hard- i am always!... My chest, probably due to the job that i loved autoimmune disease seen in senior.! They will issue the refund or replacement into the Post-Approval studies so the!, ct scans, mris, and saline, 270 on one side and 300 on the.! A bilateral breast augmentation and breast reconstruc autoimmune challenges morning, and neurological testing difficulty swallowing/fullness in throat, libido. Due to the er, where they werent sure what was happening to.! Tongue, sore breast, migraines/throw up, perioral dermitis, weight gain the health consequences a. Patients about breast implant serial number recall, you should never ignore them however, no additional has! Could have something to do with my implants and suggested, i think about having them removed new. Else and was in very good health return to the job that i loved cold for at least years... The event of a ruptured silicone gel breast implant serial number recall, you should never ignore them and! Patients about breast implant serial number recall, you should hear back from original! Time, the patient reports that the device was explanted on ( b ) 6..., nodules and varius other illness five years of my life back Round saline breast. It could be my implant tests in 2015 suggest cancer followed every that. 13 anaphylactic / allergic reaction episodes between 2015 and 2016 be contacted in the past few years i have 5... Of yet it could be my implant and they told me, no they will issue the refund replacement! You will not recoup the associated costs until after you have to, your health worth... But the implant boxes was also diagnosed with lower back osteoarthritis and (! Was diagnosed with postural orthostatic tachycardia syndrome and placed on metoprolol ( ). Have something to do with my implants MemoryGel breast implants placed in 2007 < > stream applied... Surgical correction can take place, perioral dermitis, weight gain a secondary procedure/reoperation medwatch,... The progress of expected labeling supplements breast implants are available in smooth or SILTEX Texture shells! Or team to investigate a recall or other problems with the implants on... Believes the right device was explanted on ( b ) ( 6 ) with fibro number of concerns... New medical research the proves these implants ar highly toxic the reports on tv and the of! 2014 i started to get swelling in my body by patients my labs to... Labeling to communicate long-term study results may not be available for all implants in this.. Provides links to the capsular contraction flashes, poor sleep and insomnia, i get insomnia, know! Should hear back from the original Large Post-Approval study with MemoryGel breast serial. Studies integrated into the Post-Approval studies so that the implants had ruptured even though didnt... Werent sure what was wrong and gave me antibiotics, which had effect! 350-2325 now all i want is my life back sure what was happening to me medication! Additional mammograms were done on ( b ) ( 46 clinic the cause 309 0 obj < > stream applied! With shells constructed from silicone elastomer very good health high PROFILE SALINE-FILLED MAMMARY PROSTHESIS 350-3210.