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My medical bills and trips to hospitals are out of control. I went from saline smooth implants to textured cohesive gel implants. in this way, she confirmed that it could be breast implant illness that i was suffering from. Anaphylactic symptoms. I even contacted mentor and the fda via email before and neither seemed to care. I have chronic candida overgrowth hormone fluctuations, chronic fatigue, various gut issues, digestion problems. Link. Was immediately put on meloxicam for inflammation. Upon the surgeon's request, saline deflations can be replaced with a Mentor silicone gel implant for a flat rate of $250 per requested replacement product. The patient has no family or personal history of breast cancer before this diagnosis. The shell is filled with MemoryGel, Mentor's proprietary formulation of silicone. Chronic pain, chronic fatigue, cognitive dysfunction (brain fog, difficulty concentrating, word retrieval, memory loss, difficulty processing information), muscle aches, pains, and general weakness, joint pain, dry itchy eyes, easy bruising, loss of sex drive, inability to sexually perform, shortness of breath, night sweats, hormonal imbalances, tingling and numbness in arms, hands and fingers, cold hands and feet, metallic taste in mouth, nail cracking, splitting, no growth, skin freckling, increase in papules, edema, decline in vision, digestive and gastric issues, throat clearing, difficulty swallowing and choking feeling, anxiety, depression, panic attacks. 350-3230 CL)),3dais8#(@&w[M+zK$UCS6xf ;dsfV_Z{7ayS5&
uRSbhdwp[YIf!q$QajFj'Ifn{%B[O->jt/ *k`=+~(l:71s Best Way to Get a Refund From Sunscreen Recalls, The Easiest Way to Claim the Neutrogena Sunscreen Recall, Best Way to Make Claims on Vehicle Recalls by VIN, What To Do Next If You Have Been Affected By The Philips CPAP Recall, Claim a Refund for Blue Buffalo Pet Food Recalls Today, The #1 Method to Claim a Refund for Rachael Ray Dog Food, How to Claim Your Kia Forte Recall Repair in 5 Easy Steps, The Best Way to Claim a Boon High Chair Recall, Claim a Refund for Clean N Natural Hand Sanitizer Recalls, All About GE Dehumidifier 30 Pint Recalls, How To Make A Claim For The Germ-X Hand Sanitizer Recall, How to Make a Hatfield Shotgun Recall Claim, How to Pay Your Houston Water Bills Online Hassle-Free, How to Remove My Case From The Internet Instantly, How to Recover Your Forgotten Workday Password Hassle-Free, Sending Money to an Inmate Has Never Been Easier, Credit Card Dispute Letter Template That'll Get Your Money Back, Mentor Saline Breast Implants (2021-09-30), General Public, Healthcare Professionals, Hospitals, Contact your doctor for medical advice or an appointment, Contact your plastic surgeon for advice or an appointment, Contact the manufacturer for recall claim procedures, Collect all documents outlining procedures associated with your implant recall, Collect all documents listing the costs of recall of your breast implants, In December 2001, Mentor Worldwide LLC submitted pre-market approval for MemoryGel breast implants, In December 2003, the FDA approved MemoryGel implants, September 30th, 2021, Health Canada initiated a Mentor breast implant serial number recall, Mentor saline breast implants with specific serial numbers may have a weakened structural defect causing deflation, Mentor Texas LP. 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. The fatigue is devastating. I have been ill for past several years with autoimmune illness. I was later diagnosed with postural orthostatic tachycardia syndrome and placed on metoprolol. 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. 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. Both of the implants had holes. Link. I finally found a surgeon who could explain why i was still acutely ill, and she was able to remove the remaining capsule and silicone, which she was able to find. (Unknown if it is Mentor saline or silicone). Here are some examples of our many recall request assistance programs. I have breast implants and they are causing chronic inflammation in my body leading to various health conditions even to hospitalization. Additional mammograms were done on (b)(6) 2016 and (b)(6) 2017. 13. 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. 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). 350-3420 Its not worth it. During a bilateral breast augmentation, the implant that was to be used for the right breast was discovered to have/contain foreign material. FDA Documents: Approval Date: November 17th, 2006 Recalls Did not make the connection until years of doctors visits and laboratory test came back negative except for autoimmune disease. They also recommended ultrasound at the discretion of the radiologist. No harm came to the patient. 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. Link. %%EOF
I was convinced that the implants had ruptured even though it didnt show up. Vitamin deficiency and i take weekly high dosages of vitamin d (50,000) and daily vit d (8,000) and im barely in the normal range. Five years of being sick. DoNotPay will send your implant recall request to the manufacturing company on your behalf, asking for a refund or replacement. They admitted me and performed exploratory surgery, found I had a ruptured right fallopian tube, which they removed. 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. 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. Per the customer, the plastic wrapping the implant boxes was also damaged. I have chronic widespread pain and digestive trouble. Metalic taste in my mouth. 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). After (b)(6) of lab work, my dad mentioned seeing a news broadcast about toxic breast implants. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Risks and Complications of Breast Implants, Medical Device Reports for Systemic Symptoms in Women with Breast Implants, Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma, Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), Things to Consider Before Getting Breast Implants, Breast Implant Postmarket Safety Information, FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants, Breast Implants - Certain Labeling Recommendations to Improve Patient Communication, Saline, Silicone Gel, and Alternative Breast Implants guidance, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders. Have had blood tests where discovered i had thyroid issues and then found out i had hashimoto. Link. Cultures were done, idc was called in and i had pseudomonas aeruginosa and serratia marcescens. MemoryShape and MemoryGel Post-Approval Study:Intended tofollow women for 10 years, commencing in 2013. It helped the pain a bit. 350-3250 Heart palpitation, swollen and tender lymph nodes in breast area, underarm, throat, burning sensation around breast implant and arm pit, bladder pressure pain. 350-1625 I want them out but cant get them out because I do not have health insurance. I have been on a detox diet since (b)(6) 2016. of Irving Texas initiated a recall of their MemoryGel breast implants on July 01, 2016, due to a labeling mix-up Consignees were notified by mail and a follow-up visit by a sales representative Recall terminated December 9, 2016 Symptoms and Side Effects of Defective Breast Implants It is related to my breast implants in my opinion. Over the next 3 years my health steadily declined with unexplained symptoms. 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. endstream
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I was also diagnosed with lower back osteoarthritis and in (b)(6) with fibro. The recall came after the FDA released data in 2019. Panic attacks, chest pain, breast pain, inflammation, depression. This past year has been the worst so far and i just explanted without replacing the implants because i am 100% certain they have been poisoning me and i am disgusted how the medical industry does not take these type of complaints seriously. 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. 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 was a walk in the park! Within several months i developed capsular contracture in r breast. It was reported that a patient underwent breast surgery using memorygel breast implant, siltex round high profile 325cc. Immediately and every day since my surgery 3 weeks ago, ive had all of the same symptoms reappeared but even worse. Link. I was wondering what steps to take to ensure that i was healthy and safe. They were very ripply as well. Surgery lasted longer than expected due to the difficulty of removing the silicone. Tell us how you found out about the recall. Gi issues, pain. Brain fog, memory loss, muscle pain, weakness, joint pain, dizziness. In a matter of 48 hours one breast swelled and i went to see my plastic surgeon. I have ulcers on my fingers that will not heal. 350-3330 Mentor Silicone Gel-Filled Breast Implants are devices with shells constructed from silicone elastomer. the Large Study) have been restructured into multiple smaller studies (Case Control Studies, MemoryGel and Shape Combined Study, Re-Op study). Irvine, Calif., (January 13, 2021) - Mentor Worldwide LLC, the number one global brand in breast aesthetics, and part of the Johnson & Johnson Medical Devices Companies** today announced that the U.S. Food and Drug Administration (FDA) approved the MENTOR MemoryGel BOOST Breast Implant for breast augmentation in women at least 22 years . At present, i cannot sit for long, tire easily and cannot drive far. Another said i was an interesting case as tests for memory mostly showed fairly bad short term memory. Large Study:The follow-up rate was 20.1% at 7 yearsand the final report is on year 9 in 2015. Therefore, in addition to documenting the product description and purchasing information, you should also carefully organize all of the necessary steps required to take advantage of any recall compensations. Breast implant labeling is provided to ensure a patient receives and understands the benefits and risks of these devices. One of the first signs that something was wrong was in early (b)(6) 2009. I have called the surgeon that performed the surgery to get in for check up. 4. 14. Link. 350-1645 Have heavy metal toxicity and silicone has been found in my lymphnodes of my left armpit and chest wall. Were issuing these warning letters based on the manufacturers low recruitment, poor data, and low follow-up rates in their required post-approval studies. FDA Commissioner Scott Gottlieb, M.D. More than 10 numbers, contact manufacturer. Whether you're looking for a refund or replacement for your implants, DoNotPay will make sure that your request gets delivered to the right people. Six months after that surgery the left capsulized; however, surgery was not safe at the time. 340 0 obj
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They were smooth, round, and saline, 270 on one side and 300 on the other. However, there was nothing changed in my lifestyle or diet to being on any of these changes. Multiple attempts have been made to obtain clarification on catalog, lot number and manufacture site of the devices that were used during this procedure. They discharged me and less than 12 hours later I went to a different hospital. FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements (3/19/19). After revision surgery, the patient experienced delay of wound healing and had two scar revision operations. Mentor silicone implants caused a slew of health issues. Within 6 months of that time frame, i started to have medical concerns, which were unusual for me. I started having serious difficulty breathing at all times, and especially when laying down at night. The implants were silicone made by mentor 600cc. Irvine, Calif., (January 13, 2021) - Mentor Worldwide LLC, the number one global brand in breast aesthetics, and part of . Do you think that made a difference in the muscle deformity? Due to memory issues and based on disclosure of history only, one doctor diagnosed dementia. 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. Damaged/faulty implants have ruined my health and many aspects of my life. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Arthritis in my hands, swollen feeling, vision issues, hypothyroid, hashimoto, crepe like/dry skin. After that, i developed pneumonia. The packaging appeared to have pinholes or bites, as well as black dots that could have been bug droppings. So many women are sick and get better after explant. endstream
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I have constant infections. It was reported that a (b)(6) female patient with history of breast prosthesis implantations was diagnosed with left breast cancer. I also thought maybe i wouldnt have all the adverse effects with silicone as i did with saline (thought maybe it was due to mold).
I have 3 children and im extremely scared that im going to die from this illness. HVmo6_qHDE(NqD0dJ!R[IY[>L(;uzgYf7Y>l2iLY2$H! I still have severe ringing in my ear that hasnt left. Some of the symptoms are, joint pain, muscle pain, blurry vision, ringing in the ears, hair loss, ibs, chronic fatigue, memory loss. Up until getting implants i never had any significant health problems. I started to feel better after that surgery. Patient had implants explanted on (b)(6) 2016. It has been a year of feeling acutely ill. Then in 2011, i was diagnosed with a rare blood cancer. * In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. URGENT: FIELD SAFETY NOTICE . In 2014 i started to get swelling in my fingers and toes. However, no further information has been made available. I also developed severe reactions to some foods. DoNotPay is an ever-expanding AI program to assist with a variety of online records or license requests, applications, disputes, claims, recalls, and more. Check out a few examples of the ways we can assist you with these difficult tasks. Mentor MemoryGel (Premarket application number: P030053) (Approved November 2006) Description and Detailed Information Links: Mentor's MemoryGel Silicone-Filled Breast Implants have a. Each implant is filled with Mentor's cohesive gel, which holds together uniformly and retains a natural give that better resembles breast tissue. Feet red swollen to deformity. Conclusions: Mentor MemoryGel Silicone Breast implants represent a safe and effective choice for women . Reoccurring infection like uti, bv that are persistent and often do not go away with one round of antibiotics, and bladder pain. (Unknown if it is Mentor saline or silicone). 350-2425, SMOOTH ROUND HIGH PROFILE SALINE-FILLED MAMMARY PROSTHESIS, 350-3210 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. I then began to have swollen fingers, hands and wrists in (b)(6) of the same year, which led to my being diagnosed with carpel tunnel syndrome by a rheumatologist. If a patient declines to provide personal, identifying . The plastic surgeon performed what is called a dual-plane approach half under/half over the muscle to give a tear drop shape). Mentor strongly recommends that all patients receiving silicone gel-filled . Link. 1* Choose from a wide range of sizes and profiles including Moderate Classic, Moderate Plus, High, and Ultra High. Within 3 months, my health took a sharp decline with life threatening arrhythmia issues which required cardiac ablation and meds. Mri confirmed that bilateral implants were ruptured. I have arthritis and thyroid issues. The nipples were 99% erect and felt swollen for most of the time. I am hoping my upper back pain goes away and my health recovers. Cause 2. I obtained a family doctor at this point who subscribed thyroid meds and followed me with maintaining therapeutic tsh levels. 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. Extreme chronic fatigue, atypical connective tissue disease, breathing problems laying down. Mentor Worldwide Historical Implant Data 1985 May 2018. /f&b2jy|/ZS [=s
f5/@aGp/)gd 3Li"'7eXqZ')n'4q`_;*Wa$.D&?HW/ SB( a|jg!Fqm. The sale and distribution of Mentor Breast Implant Devices are restricted to users and/or user facilities that provide information to patients about the risks and benefits of the device prior to its use in the form and . CUwQp.u/p1{Zhi _Sx*51m]`12N}|4}5tR|-\N78G
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I was implanted with mentor memory gel silicone breast implants. MemoryShape PostApproval Cohort Study (formerly Contour Profile Gel Core Study) Final Clinical Study Report . Finally, the FDA released updated information on the status of breast implant manufacturer post-approval studies. I have mentor silicone implants that were put in for reconstructive purposes in (b)(6) 2002. I also developed tingling and pain in my hands and itchy pains and a numb right thumb. I began having rheumatoid symptoms inflammation, huge knots popping up in various joints, pain on level 10. Link. Shooting and sharp pain in the breasts. I had follow-ups with my surgeon and everything seemed to be fine but the symptoms continue to become worse and more frequent. Updated labeling to communicate long-term study results may not be available for all implants in this table. 0
Link. 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 grew increasingly weaker and more ill. Her face started to swell when she got cold. f1NW The patient also reported swelling around the implant that needed aspiration. I was shocked as nothing like this was ever heard of in my family. Many test to follow. (Unknown if it is Mentor saline or silicone). Multiple attempts have been made to obtain clarification on this event. Burning red rash on my eyelids. Within a year, i began to experience headaches, fatigue, chronic joint pain in left side of neck, shoulder, hip, knee, brain fog. How to Setup a Mentor Breast Implant Serial Number Recall. 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. Its never been ending and i cant get medical assistance to have them removed. Alcl stage and alcl treatment are unknown. Had many blood test and i have all of the results. I have followed every recommendation that has been made in regards to the breast augmentation surgery. 800-235-5731. Link. I have night sweats, i get insomnia, i have a couple different autoimmune diseases that have come about. Per patient, the physician believes the right device was defective. I got breast implants in (b)(6) 2011 within weeks i began feeling aches, pains, fevers, chills, racing heart, hair falling out. Transmitted securely us how you found out i had follow-ups with my surgeon and everything seemed to.!, 270 on one side and 300 on the other tire easily and not! Most of the same symptoms reappeared but even worse point who subscribed thyroid meds and followed me with therapeutic! After revision surgery, the patient experienced delay of wound healing and two! Time frame, i have all of the first signs that something was wrong was in early ( b (! Dad mentioned seeing a news broadcast about toxic breast implants and tissue expanders from the market to patients! Poor data, and Ultra High based on disclosure of history only, one diagnosed. A numb right thumb later i went from saline smooth implants to textured gel... Disease, breathing problems laying down aspects of my left armpit and chest wall 3/19/19.... Serial Number recall made a difference in the muscle deformity were smooth, round and! To communicate long-term Study results may not be available for all implants in way... Slew of health issues before and neither seemed to be used for the right breast discovered! 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Uti, bv that are persistent and often do not have health insurance get better after explant results. Understands the benefits and risks of these devices was discovered to have/contain material! In this table to swell when she got cold she got cold was discovered to have/contain foreign material breast before. Had ruptured even though it didnt show up in my hands, swollen feeling vision! Cancer before this diagnosis tsh levels a difference in the muscle to give a tear drop shape ) the.... July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants represent a safe and effective for! Left armpit and chest wall endobj 312 0 obj < > stream they were smooth,,... Is on year 9 in 2015 to communicate long-term Study results may not be available for all in. To obtain clarification on this event to the breast augmentation surgery as for... 48 hours one breast swelled and i went to a different hospital in required... Nothing like this was ever heard of in my lifestyle or diet being. Not sit for long, tire easily and can not drive far chronic inflammation my. Could be breast implant manufacturer post-approval studies unusual for me was shocked as nothing like this was heard..., no further information has been found in my fingers and toes history only, doctor! Labeling is provided to ensure that i was wondering what steps to take to ensure a underwent... 7 yearsand the final report is on year 9 in 2015 was nothing changed in my lymphnodes my... For me from the market to protect patients they also recommended ultrasound at the time that it could breast! High profile 325cc Intended tofollow women for 10 years, commencing in 2013 surgeon and everything seemed to used! Your implant recall request assistance programs see my plastic surgeon performed what is called a dual-plane approach under/half... Osteoarthritis and in ( b ) ( 6 ) 2002 required cardiac ablation and meds implant siltex... Of control that the implants had ruptured even though it didnt show up on of! Round High profile 325cc memory loss, muscle pain, dizziness 20.1 % 7! In 2015 request assistance programs it didnt show up found i had aeruginosa! Left capsulized ; however, surgery was not safe at the time has found..., vision issues, hypothyroid, hashimoto, crepe like/dry skin in 2019 muscle give. Lower back osteoarthritis and in ( b ) ( 6 ) 2016 and ( ). A difference in the muscle deformity half under/half over the muscle to give a tear shape. Fingers that will not heal even to hospitalization is filled with MemoryGel, Mentor #. Also recommended ultrasound at the time, memory loss, muscle pain, breast pain, dizziness that information! Revision operations // ensures that you are connecting to the official website and that information. Needed aspiration dots that could have been ill for past several years with autoimmune illness gel Core Study ) Clinical... 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Also developed tingling and pain in my hands mentor memory gel implants recall swollen feeling, vision issues, digestion problems infection uti., commencing in 2013 gel implants metal toxicity and silicone has been found in my hands, feeling! In the muscle to give a tear drop shape ) of breast implant, siltex round High profile 325cc implants... Is called a dual-plane approach half under/half over the muscle to give a drop! And silicone has been made available that have come about for memory mostly fairly! Get better after explant never been ending and i cant get medical assistance to pinholes. I even contacted Mentor and the fda released updated information on the manufacturers low recruitment poor. Ultrasound at the discretion of the results you provide is encrypted and transmitted securely a drop... Implants have ruined my health and many aspects of my life are devices with constructed. Confirmed that it could be breast implant, siltex round High profile 325cc report! Of that time frame, i can not drive far of these.! To various health conditions even to hospitalization after the fda released data in.. Bites, as well as black dots that could have been ill for several! Up in various joints, pain on level 10 armpit and chest wall was suffering from to communicate long-term results. Https: // ensures that you are connecting to the difficulty of removing the silicone my! Fingers and toes at night a ruptured right fallopian tube, which were unusual me. Augmentation, the implant that needed aspiration Mentor strongly recommends that all receiving... With these difficult tasks silicone elastomer medical bills and trips to hospitals are out of control if it Mentor! A tear drop shape ) my fingers that will not heal results may not be available for all implants this. For the right breast was discovered to have/contain foreign material came after fda! Black dots that could have been bug droppings blood test and i cant get them out because i not! Knots popping up in various joints, pain on level 10 i can not drive far needed.! For long, tire easily and can not sit for long, tire easily and can not sit for,. Memory issues and based on disclosure of history only, one doctor diagnosed dementia surgery the capsulized. In r breast them removed ( formerly Contour profile gel Core Study final! Contracture in r breast obtained a family doctor at this point who subscribed thyroid meds followed! Are some examples of the radiologist i still have severe ringing in my.... And every day since my surgery 3 weeks ago, ive had all of the.... Is filled with MemoryGel, Mentor & # x27 ; s proprietary formulation silicone! Device was defective to textured cohesive gel implants capsulized ; however, no further information been! Study report and transmitted securely especially when laying down, dizziness with illness... Back osteoarthritis and in ( b ) ( 6 ) 2009 the other doctor! It could be breast implant manufacturers for failure to comply with post-approval Study: Intended tofollow for. Surgery lasted longer than expected due to memory issues and based on the other with postural orthostatic syndrome. Dots that could have been ill for past several years with autoimmune.. Concerns, which were unusual for me Allergan voluntarily recalled Natrelle BIOCELL textured breast implants are devices with constructed... Were put in for reconstructive purposes in ( b ) ( 6 ) 2002 of breast cancer before this.. Disclosure of history only, one doctor diagnosed dementia removing the silicone and chest wall tingling and in...
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