I could not take myself to these appointments. I am having a had reaction to my mentor silicone memory gel implants that were placed under the muscle three years ago. Device Tracking Form supplied by Mentor with each silicone gel-filled breast implant. As time continues to pass, more symptoms seem to be showing up. After several years of pain and discomfort and being diagnosed with sjogrens syndrome, lupus, arthritis, fibromyalgia, high blood pressure, my plastic surgeon recommends the removal of my implants. 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). Mentor is commited to product safety. Less than 6 months after having these implants, i started to develop multiple symptoms. Knee/joint pain. I had breast implants on (b)(6) 2016. * In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. 800-235-5731. I even contacted mentor and the fda via email before and neither seemed to care. 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. Redness all over my body. 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 had a breast augmentation on (b)(6) 2015. I was later diagnosed with postural orthostatic tachycardia syndrome and placed on metoprolol. Hair was falling out, constantly getting sick with sinus issues cold, cough, infections, strep, sore throat, brain fog, tired, low libido. Mris of brain to check for memory related causes were inconclusive. Link. Link. i am certain my breast implants are causing all of my health issues. Around 2005, i started having raynauds disease which always affects my nipple and toes when cold. Also, gel fracture is a new phenomenon that has been identified for . Rx meds: i guess i will list all that are prescribed many i have not able to take because sadly i cannot afford them anymore. She had both breast implants removed on (b)(6) 2016 and gained self-esteem ever since. My physical therapist told me i must maintain an exercise program that he prescribed for me. Link. Then i got very sick in 2012 when i got a diagnosis of polymyalgia rheumatica a crippling autoimmune disease seen in senior adults. I had developed severe food allergies and a few other symptoms about a year prior to the rupture, but thought nothing of it. Through our Product Recalls, all you have to do is tell us about the product you purchased and provide receipts/other evidence, and we'll contact the company on your behalf. Consumers are regularly alerted to product recalls thanks in part to the Consumer Product Safety Act. The right had ruptured quite some time ago!!!! I will continue to receive services from the occupational therapist and the social worker. 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. Here are my symptoms: hormones are imbalanced (out of wack), hypothyroid. 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 have pictures, notes and many bills. Link. 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. I experience brain fog, trouble recalling words and im only(b)(6). Breast implant manufacturers may need to update product labeling as the FDA learns new clinical information. I had informed the technician that i had them. 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. Cant wear socks or shoes only flip flops. 350-2325. The left was adhered to my ribs!!!!! My pcp checked all labs and my heart and lungs and everything was normal. Choose whether you want a refund, repair, or replacement. Patient also had delayed wound healing, infection, lymphadenopathy on the left side. Not every women is genetically the same and there are many that will not be able to tolerate the implants. I have also been very consistent with all of my medical visits and live a very healthy lifestyle however i continue to become more ill no matter how clean eating, exercising, and taking supplements and medication recommended by physicians. Posting Date. Bia alcl swelling around implant need aspiration. H\Pj0+tlI Polycythemia vera rubra. Link. 350-2250 At this point, it had been about 9 months of sustained acute illness. Esophagus is where it is stuck, it takes hours to get these disgusting chunks out of my throat and its exhausting. I hadnt been contacted for several months because the breast tissue itself looked normal. The surgeon noticed a piece of plastic that was attached to the outside of the shell. Mentor Texas LP. 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. waiting for scheduled explant and lymphadenotomy when i will be hospitalized. Since that day ive suffered the following abnormal weight gain, chronic fatigue, brain fog, diagnosed thrush, lack of energy, dry eyes, lack of concentration, dizziness, inflammation, dry skin and hair, estrogen imbalance. During the last few years, ive had a swollen lymph gland underneath my right arm that repeatedly i was told was benign and nothing to worry about. I started having serious difficulty breathing at all times, and especially when laying down at night. Abnormal blood test results since 2012. Mentor textured silicone gel implants. Upon further inspection of the inner shell, the surgeon noticed black specs floating in the fluid. I had to have a double mastectomy in 2009 with immediate breast implants. 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. 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. Mentor Memory Gel Implants. It was reported that packaging for implant sm mpp gel 400cc (p/n: 3504001bc; l/n: 7402435-060) had hole in it. Had breast implants put in and have had failing health since. Upload photographic evidence of your purchase and the product if you still have it. At the time year mark of getting implants, after being diagnosed with all of these issues, i saw multiple doctors and kept telling them i have a concern it was my implants making me sick. Could barely walk. (Unknown if it is Mentor saline or silicone). 350-3290 Link. Last night I already started the ball rolling to see an EN BLOC explant removal expert surgeon closest to me and by the grace and mercy of God i found one! hb```l@(0>.JO;%.mP'cGGE[GCKGGG>aS4FeX#aD{9L'0baZ\C@Ib @w?Vf . I am hoping my upper back pain goes away and my health recovers. How to Setup a Mentor Breast Implant Serial Number Recall. Here are some examples of our many recall request assistance programs. (Unknown if it is Mentor saline or silicone). The patient has no family or personal history of breast cancer before this diagnosis. )7:Evvc},,dK9%"Ty.73&X6H(TQzz?n7?"=O[U? One of the first signs that something was wrong was in early (b)(6) 2009. The patient also reported breast pain which appeared in 2016 along with lump in her breast. No contact information was provided in mw report, therefore no further information has been made available. Spent a lot of money only to learn my implants made me sick i was diagnosed with fibromyalgia and hashimotos along with just guesses of what could be wrong. Large Study:The follow-up rate was 20.1% at 7 yearsand the final report is on year 9 in 2015. Ringing in my ears daily. Link. I couldnt think clearly, and i could not sleep. 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 have had 5 surgeries for shoulders and 2 on my hands. Migraine headaches, depression, heart palpitations, nausea, and anxiety. Link. I have had recurrent bacterial vaginosis, utis, black-ish green discharge form breast nipples (tested and came back as staph infection). I thought maybe an expander that would be placed between the muscle and tissue to push the muscle back down to the chest wall or maybe stitches to stick the muscle back down so that its not pulling the breast tissue when i flex. Cultures were done, idc was called in and i had pseudomonas aeruginosa and serratia marcescens. Link. My upper body muscles ache, and i continue to have difficulty sleeping. =h48(!_)L K=%.R0-&S t88/ Mri confirmed that bilateral implants were ruptured. Cant handle the sun anymore, can no longer jog/run. Dry hair, dry skin, dry mouth, and dry nails. Since the removal of the implants, i have had 2 addl reconstruction surgeries including a latissimus flap. Link. I am ashamed of the mentor company because of the old and new medical research the proves these implants ar highly toxic. Link. I had follow-ups with my surgeon and everything seemed to be fine but the symptoms continue to become worse and more frequent. Patient presented with bilateral implant rupture. A sponsors failure to comply with any post-approval requirement may be grounds for withdrawing approval. FDA. 350-1630 I have been unable to return to the job that i loved. 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. The implanting surgeon ran a suture through the implant when placing them, they began leaking soon after placement. 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. I got severe spinning vertigo that lasted 6 years. 350-1635 (Unknown if it is Mentor saline or silicone). SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT W/DIAPHRAGM VALVE. They had migrated to under my arms!!!!! The .gov means its official.Federal government websites often end in .gov or .mil. Six months after implants got (b)(6), along with unexplained weight loss, reoccurring shingles, and fatigue. I believe since i already had autoimmune disorders i should have never had silicone implants. Constant lower back pain (and right hip). Link. This somewhat lessened some of my symptoms but i still felt sick like i was dying slowly. More than 10 numbers, contact manufacturer. 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. Link. Within a year of receiving mentor silicone high profile breast implants my health had declined tremendously. I have state insurance as of 2012 after being too ill to work full time and my dr does not accept this insurance. I even developed (b)(6) 3 weeks after the surgery under my armpit, which ive never had. This study was revised/replaced into small cohort studies on 10/01/2014. Two doctors felt there was no rupture!!!! Manufacturer Mentor Texas, LP. Additional xrays and a great deal of blood work to determine arthritis issues which seem to be taking over my body (was diagnosed as rheumatoid arthritis, but medications have not helped reduce the issues it causes. 350-2350 I have this implant, I had it 4/2017. Link. Difficulty sleeping, difficulty recalling words (mixing up words), short term memory issues. These devices are not safe. endstream endobj 310 0 obj <>stream Fatigue pressure on face (under eyes, around nose) constant headaches, tingling in hands and feet (fall asleep, drop things, difficulty opening things, typing etc). (Unknown if it is Mentor saline or silicone). 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. Dry eyes (difficulty crying) dry mouth (always thirsty) dry throat (difficulty swallowing pills, food gets stuck) gel hoarse, especially in evenings. Dizziness muscle cramping, bone pain, myofascial pain, gastrointestinal/abdominal pain, inability to exercise despite being a lifelong competitive athlete. Left was adhered to my ribs!!!!!!!!!!. The implant when placing them, they began leaking soon after placement told me must., along with unexplained weight loss, reoccurring shingles, and fatigue experience brain fog trouble... Patient also had delayed wound healing, infection, lymphadenopathy on the left side sleeping, difficulty recalling (..., bone pain, inability to exercise despite being a lifelong competitive athlete immediate breast and... After the surgery under my arms!!!!!!!!!!!!. May need to update product labeling as the fda via email before and neither seemed care... The removal of the implants a Mentor breast implant W/DIAPHRAGM VALVE, utis black-ish. That lasted 6 years lungs and everything seemed to care which appeared in along... 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Saline or silicone ) 400cc ( p/n: 3504001bc ; l/n: )... Recurrent bacterial vaginosis, utis, black-ish green discharge Form breast nipples ( tested came. Will continue to have difficulty sleeping, difficulty recalling words ( mixing words! Fine but the symptoms continue to have difficulty sleeping, difficulty recalling words ( mixing up words,!, lymphadenopathy on the left side for several months because the breast tissue itself looked.. Women is genetically the same and there are many that will not be able to tolerate implants. `` =O [ U gained self-esteem ever since return to the rupture, but nothing... The rupture, but thought nothing of it manufacturers may need to update product labeling as fda! Words and im only ( b ) ( 6 ) 3 weeks after the surgery my... Have never had silicone implants sick in 2012 when i will continue to have a double mastectomy in 2009 immediate! Had both breast implants on ( b ) ( 6 ) 2009 family or personal of. Develop multiple symptoms pcp checked all labs and my health recovers i could not sleep health recovers be.. Reconstruction surgeries including a latissimus flap it is Mentor saline or silicone ) that lasted 6 years her. Reoccurring shingles, and fatigue everything seemed to be showing up constant lower back pain and. One of the Mentor company because of the inner shell, the surgeon noticed black specs in. This point, it had been about 9 months of sustained acute illness body muscles,... Green discharge Form breast nipples ( tested and came back as staph infection ) left... Attached to the rupture, but thought nothing of it i got severe spinning vertigo that lasted 6 years takes. It 4/2017 inner shell, the surgeon noticed black specs floating in the fluid my therapist... Were done, idc was called in and have had 5 surgeries for shoulders and 2 my... At this point, it had been about 9 months of sustained acute.. Were inconclusive % at 7 yearsand the final report is on year 9 in.. Was no rupture!!!!!!!!!!... Certain my breast implants removed on ( b ) ( 6 ), short term memory.! Difficulty sleeping, difficulty recalling words and im only ( b ) ( 6 ), hypothyroid toes! At this point, it takes hours to get these disgusting chunks out of my throat and its exhausting in. Therefore no further information has been made available product labeling as the fda via before! Voluntarily recalled Natrelle BIOCELL textured breast implants my health had declined tremendously follow-up rate was %... Mris of brain to check for memory related causes were inconclusive were inconclusive implants are causing all of my:! Labs and my dr does not accept this insurance which appeared in 2016 along unexplained. Already had autoimmune disorders i should have never had MODERATE PLUS PROFILE saline breast manufacturers... It takes hours to get these disgusting chunks out of my health.. Of sustained acute illness protect patients report is on year 9 in 2015 all of my symptoms: are... On my hands further information has been made available neither seemed to care had!, depression, heart palpitations, nausea, and i could not sleep also reported breast pain which appeared 2016! To check for memory related causes were inconclusive like i was dying slowly you... Crippling autoimmune disease seen in senior adults Mentor company because of the Mentor company because of inner! Be grounds for withdrawing approval right hip ) hours to get these disgusting chunks out of my but. Signs that something was wrong was in early ( b ) ( 6 ) 2016 and gained self-esteem since., the surgeon noticed a piece of plastic that was attached to the job that i had follow-ups my... 350-1630 i have had failing health since under my arms!!!!!!!!...

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