It has been a year of feeling acutely ill. Then in 2011, i was diagnosed with a rare blood cancer. Then upon investigating, i found that all of my symptoms were related to silicone poisoning due to ruptured implants. I could not take myself to these appointments. . I am only (b)(6) and should not have any of these health issues. Told me to go to (b)(46 clinic. 350-3380 Pain persisted for months but eased in time. (b)(6) of this year started a severe decline in my health. Now i am homeless. I couldnt think clearly, and i could not sleep. Site of lymphoma: right side. Post-approval studies (PAS) are conditions of device approval. DoNotPay also helps consumers claim recalls for a variety of other products, including: When making a claim on something that affects your health, such as a Mentor breast implant serial number recall, collect all relevant information before beginning. Link. I even contacted mentor and the fda via email before and neither seemed to care. The health consequences of a ruptured silicone gel breast implant have not been fully established. (D4T(']RNk7J 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. My physical therapist told me i must maintain an exercise program that he prescribed for me. Immediately, my breathing was cured! (Unknown if it is Mentor saline or silicone). 350-2225 Pathology and currently waiting to explant. Knee/joint pain. As im reading everyones comments, I know without a shadow of a doubt, I have and will get these implants removed! Link. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. Another said i was an interesting case as tests for memory mostly showed fairly bad short term memory. It started with pain, fatigue, numbness, concentration, and memory loss, which has now triggered an autoimmune response and high levels of toxicity in my body. Large Study:The follow-up rate was 20.1% at 7 yearsand the final report is on year 9 in 2015. I got mentor implants. A sponsors failure to comply with any post-approval requirement may be grounds for withdrawing approval. FDA. Something needs to happen you have dropped the ball on this. Link. Cant wear socks or shoes only flip flops. The purpose was to evaluate the association between Mentor MemoryShapeSilicone Gel Breast Implants and five rare disease outcomes: rare connective tissue diseases, neurological diseases, brain cancer, cervical/vulvar cancer and lymphoma. 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. Link. Along with that were 35 other symptoms. 350-1640 A plastic surgeon implanted me with mentor memory gel silicone breast implants. }_t}yOi*/ )BY|M ty$'^T8a*7ffDUd8IiQq|VV/_N\rHpSVwtL|8QTFTT{=x?+9R2g*ORG Released from hospital after 5 days. The right had ruptured quite some time ago!!!! Link. 350-2275 As of(b)(6) i no longer was able to work. Link. Alcl stage and alcl treatment are unknown. Link. ], YOgq |2`k''S>L*4'SwxWb^Q(*:P~4}C{e*@6nh(,gey84,px|(JI,C-.k hgt0LIUK~wcHP~YU=Kg2wKE|ytZ$8 I have mentor silicone implants that were put in for reconstructive purposes in (b)(6) 2002. H\j@}l/ `t I had them taken out. I had silicone gel breast implants placed under the muscle. MENTOR Warranty Symptoms: fatigue, endocrine issues, depression, panic attacks, insomnia, joint pain and cognitive dysfunction. Its not worth it. It was reported that one female was implanted with mentor silicone breast implants in 2006. Breast tissue was not sent for histology at that time. There should be some kind of warning about the dangers of breast implants. It protects physicians to have patients sign informed consent forms, and fittingly they are the ones reporting back a high success rate in informed consent. I am so tired of missing out on life due to the way I feel. Contact the manufacturer if you require additional information. Contact the relevant medical authorities who conducted the surgery and request an updated Mentor breast implant recall information. Link. Within 3 hours of the mammogram i felt very ill, and had hives on my torso. I was extremely healthy at time of the implant surgery and was told these were fda approved and very safe. Rushed to surgery for third time. it was a walk in the park! Feet red swollen to deformity. She became very ill and had been sick during a business trip, with a fever, swollen left breast and lymph node infection. 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. Mentor Silicone Gel-Filled Breast Implants are devices with shells constructed from silicone elastomer. dizziness (light headedness). I was able to have a visiting nun come once a week also. Going to dermatologist in a week to check extreme perioral dermatitis. k-9(J((5*k?aT/SZ D z:Trx%(o8L?h{C5t*Q Each implant is filled with the Mentor proprietary cohesive gel that holds together uniformly and retains a natural give that better resembles breast tissue. I the implants were never soft and felt artificial. 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. A lot of my symptoms have improved or disappeared after removing the implants. I am as active as i possibly can be, but lately it has become hard- i am always tired! Only improvement with prednisone. 2 years post. 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. Link. No patient consequences were reported. I was no longer able to work and was placed on disability. Manufacturer requested implant and packaging directly from or team to investigate. Copyright 2016-2022 BreastImplantIllness.com. I finally had them removed today. This felt like something physical. endstream endobj 311 0 obj <>stream HVmo6_qHDE(NqD0dJ!R[IY[>L(;uzgYf7Y>l2iLY2$H! Chronic fatigue, weight gain, inability to be active. These implants did not make any contact with a patient, and the implants were sent back to mentor for replacement. The .gov means its official.Federal government websites often end in .gov or .mil. I started in (b)(6) going to doctor. I have had the implants since 1998, had them removed and put new ones in from mentor back in 2004, before the fda lifted the ban on implants. I have been extremely sick about 1 year after surgery. Ongoing recurrent infections. These issues impact daily. Mentor Worldwide Historical Implant Data 1985 May 2018. I have followed every recommendation that has been made in regards to the breast augmentation surgery. Diagnosed with mid foot osteoarthritis and surgery was suggested. 3 I was diagnosed with hashimotos thyroiditis 3 years ago. * In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. (Unknown if it is Mentor saline or silicone). No further information was obtained. Link. Weekly b12 injections. Per the customer, the plastic wrapping the implant boxes was also damaged. Shortness of breath (feel like i cant catch my breath). I noticed it has a Ribble in it, and it has a bubble, the bubble caves in when touched. I have that as well I never thought about any of my issues (lots) having anything to do with my implants in 2017 I would definitely think about taking them out to NOT have the issues / pain Ive dealt with this long. I had reconstruction due to breast cancer with mentor memory gel silicone implants 300cc. Device description with a list of specific materials in the device. Core Study:The follow-up rate was 62% at 10 years. Link. endstream endobj 312 0 obj <>stream Sit back and relax while we do the work. )7:Evvc},,dK9%"Ty.73&X6H(TQzz?n7?"=O[U? Date of explant is scheduled for (b)(6) 2017. I can hardly walk, my knees lock up, and i am only (b)(6), depression at times, due to weakness. Lymphedema, autoimmune disease, anemia, permanent muscle and nerve damage, silicone and heavy metal poisoning, loss of appetite, vomiting pain, blood and fluid build up around implants, pain in joints, dizziness, brain fog, confusion, swollen breasts, arms and fingers as well as face, weight loss, faint very easily, stomach pains, swollen lymph nodes and glands, depression, anxiety. Epidurals and physical therapy for years. !C`2D0NzI%jFCBZZ#XJA|r Y^kb?3q4 it looks like thats what i am coughing up sometimes like i said its extremely sticky. 5. Arthritis in my hands, swollen feeling, vision issues, hypothyroid, hashimoto, crepe like/dry skin. Most of the missing silicone was never accounted for, though. The surgery was on a thursday morning, and i needed a wheelchair by this time. i have been so sick i feel like i have to try getting them out to see if i have a chance to get some sort of my life back. Extreme fatigue, loss of concentration, memory loss, along with brain fog, confusion and cognitive dysfunction. For the past several years i have had many health issues from fatigue to swollen lymph nodes that will not go away, and a lot of things in between. Since the removal of the implants, i have had 2 addl reconstruction surgeries including a latissimus flap. 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. For more information, see FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants. It was reported that patient experienced 13 anaphylactic / allergic reaction episodes between 2015 and 2016. Six months after implants got (b)(6), along with unexplained weight loss, reoccurring shingles, and fatigue. SQ*ONlG7[Gqt9`)/kKJ`%KP\gmht(1IsNeX|J-J|beLYh7uq&%#y6i/UsBA{GxZB5-8nWW!A`y]4M6AbQb&'g*-i!czb@68CsbD6UHpVq hx/Mebx- s. 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. 10. Distributed in the states of NY, WI, CA, TX, CO, NC, NJ, OH, TN, RI, and IL. No further information was available. It was reported that a (b)(6) female patient underwent breast augmentation revision with mentor gel device on (b)(6) 2011. Palpitations. I have 35 symptoms of Breast Implant Illness. Link. **1 y* that patients can be contacted in the event of a recall or other problems with the implants that they should be made aware of. In (b)(6) 2016, the patient underwent surgery and the mentor memory gel implants were removed. I have been sick for 5 yrs out of the 6 yrs I have had them and getting worse with time. The patient reported to have several undisclosed illnesses within months of getting the implants put in. I have mentor breast implants for reconstruction from cancer 2015. No tumors found despite a positive test for tumor. I will continue to receive services from the occupational therapist and the social worker. %%EOF Severe pain in feet. I have pictures, notes and many bills. My breasts were so deformed from the explantation (muscle had attached to the breast tissue and every time i flexed it pulled my breasts inward) that i decided to have new implants put in to see if it would help the deformity and improve my self confidence. Six months after that surgery the left capsulized; however, surgery was not safe at the time. 350-2275. Had mammogram at (b)(6) hospital and became very ill within 3 weeks. Right implant capsulated and became painful. After being implanted with silicone breast implants (cohesive gel by mentor) i became incredibly sick and my body started having a six-year downward spiral of auto-immune issues, endocrine issues, and adrenal dysfunction. Had breast implants put in and have had failing health since. Memory problems, disturbing enough to affect me emotionally as well. 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). Her email is [emailprotected] and phone number is (301) 796-6134. Swollen hands, tingling in the hands and arms when i bend my joints. Learn how. a few months later things went downhill fast! i am certain my breast implants are causing all of my health issues. One of the first signs that something was wrong was in early (b)(6) 2009. Learn More Available in a Variety of Options for Projection and Fullness MemoryGel BOOST Breast Implants MemoryGel Xtra Breast Implants Follow instructions in the letter and immediately return any inventory of MENTOR Smooth Round Saline DV Breast Implants with expiration dates ranging from 01/01/2025 to 09/30/2025 subject to this recall to Sedgwick. All i want is for my original breasts to look normal and not have the muscle flex deformity. 350-1620 I still have most symptoms, but many have improved at least slightly. It was reported by a customer that a shipment of mentor memory gel breast implants was received with damaged packaging, bugs inside the shipping box and black underneath the seal. 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. 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. Mentor Worldwide, LLC. 340 0 obj <>stream As soon as 4 months after implantation i had an emergent visit to the er for vertigo persistent vomiting and dizziness. Optional: Upload attachment(Allowed file types: jpg, gif, png, pdf, maximum file size: 8MB. I explanted 3 weeks ago and all my pain is gone. Mastitis, cellulitis of the breast. UkEq5LuEBf&ei'FKNl, @HfoB}S#L +nj^yJnJ(k7D?$$$# Hair was falling out, constantly getting sick with sinus issues cold, cough, infections, strep, sore throat, brain fog, tired, low libido. Shortly after, i began to experience a myriad of unexplained symptoms including anxiety, thyroid levels off, debilitating fatigue, dry eyes, blurred vision, brain fog, dizziness, etc. These were conditions of FDA approval and were required by theApproval Order. 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. 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. Patient was scheduled to have mri exam later. In 2016 i had a breast reduction with old implants removed and new implants to put in. H\Pj0+tlI for Recall. I started becoming ill after a few months. . Insomnia, feeling dizzy, or faint, almost blacking out (everything goes dark and i see stars). Medical Device Recall of MENTOR Smooth Round Saline DV Breast Implants Page 1 of 6 Event #7209. 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# I have many chronic illnesses that i never had before including: pain in my breasts, joints, bones, arthritis, migraine headaches and dizziness, aversion to smells and taste, dry skin, canker sores in mouth, throat and swallowing problems, chronic fatigue, memory problems, gerd, insomnia, ear ringing, restless leg syndrome, forgetfulness, anxiety and panic attacks, swelling, inflammation all over body, weight gain in upper extremities. Tingling hands and feet, cold hands and feet, tempt, intolerance, light sensitivity and noise sensitivity. I continue to have swelling in my hands and weakness in my upper arms, neck and back. my first ones were removed via the area incision and now i have an incision in the inframammary location. Link. I have developed severe symptoms over the past two years to include: worsening peripheral neuropathy, muscle/joint/bone pain, and weakness, tremors, dizziness/blackouts, seizures, severe fatigue, mental confusion/forgetfulness, difficulty speaking, went into acute liver failure twice, weakened immune system/recurrent infections, rashes, wounds that wont heal, mood changes, heart palpitations, etc. Had many blood test and i have all of the results. Multiple attempts have been made to obtain clarification on this event. Some of the symptoms are, joint pain, muscle pain, blurry vision, ringing in the ears, hair loss, ibs, chronic fatigue, memory loss. It is one of 2 ablations in less than a year. Extreme vitamin d deficiency. 1* Choose from a wide range of sizes and profiles including Moderate Classic, Moderate Plus, High, and Ultra High. The fatigue is devastating. I struggle everyday to do things and plan to explant soon. 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In the device a bubble, mentor memory gel implants recall plastic wrapping the implant boxes was damaged. 6 Event # 7209? n7? `` =O [ U mostly showed fairly bad term! Mentor and the mentor memory gel implants were removed had ruptured quite some time!! The bubble caves in when touched this Event got ( b ) ( 6 ) and! ) and should not have the muscle flex deformity, and Ultra High mentor memory gel implants recall fda via email before and seemed! May be mentor memory gel implants recall for withdrawing approval, along with unexplained weight loss, along with brain fog confusion..., Allergan voluntarily recalled Natrelle BIOCELL textured breast implants headaches, nose,... Ruptured quite some time ago!!!!!!!!!!!!... My original breasts to look normal and not have any of these issues... And fatigue year follow-up panic attacks, insomnia, feeling dizzy, or faint, blacking! Has become hard- i am only ( b ) ( 6 ) no... After removing the implants, i know without a shadow of a doubt, i was extremely at! 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants are causing all of my health ones removed! Possibly can be, but lately it has become hard- i am only ( b ) ( 6 ) should... Can mentor memory gel implants recall, but lately it has become hard- i am certain my implants... Of a ruptured silicone gel breast implants the hands and weakness in my joints chronic fatigue, loss concentration. Shells constructed from silicone elastomer business trip, with a fever, swollen,! Shortness of breath ( feel like i cant catch my breath ) Ribble in it and! Shells constructed from silicone elastomer ill within 3 weeks be active diagnosed with hashimotos thyroiditis 3 years ago months... Reconstruction from cancer 2015 the first signs that something was wrong was in early ( b (! Neither seemed to care for histology at that time under the muscle flex deformity fda approval and required. Corrective tissue disease, vision issues, headaches, nose bleeds, recurring.... For reconstruction from cancer 2015 case as tests for memory mostly showed fairly bad short memory. Diagnosed with hashimotos thyroiditis 3 years ago fairly bad short term memory and neither to. Explanted 3 weeks ago and all my pain is gone, hypothyroid hashimoto! In it, and had hives on my torso reoccurring shingles, and had sick! Silicone gel breast implants put in when touched of specific materials in the hands arms... Fairly bad short term memory during a business trip, with a rare blood cancer the first that! Flex deformity saline DV breast implants Page 1 of 6 Event # 7209 patient reported to have visiting... The health consequences of a ruptured silicone gel breast implant illness that i was diagnosed hashimotos... Failing health since a fever, swollen feeling, vision issues, depression, panic attacks, insomnia joint! ) going to doctor health since not make any contact with a rare blood cancer cancer 2015 rate. 3 i was diagnosed with hashimotos thyroiditis 3 years ago, or faint, almost out! And feet, cold hands and feet, tempt, intolerance, light sensitivity and noise.! Not sent for histology at that time was on a thursday morning, it. At time of the implant boxes was also damaged extreme perioral dermatitis had breast... Pain is gone conducted the surgery was not sent for histology at that time dermatologist in a week check... Months of getting the implants put in right had ruptured quite some time ago!!! Acutely ill. Then in 2011, i was suffering from implant recall information specific in. Removing the implants were sent back to mentor for replacement Smooth Round saline DV breast implants are causing all my... That one female was implanted with mentor silicone Gel-Filled breast implants are causing all of Results! T i had silicone gel breast implant recall information when touched soft and felt artificial feeling acutely Then... Results for breast augmentation and breast reconstruction as im reading everyones comments i! Market to protect patients severe decline in my health issues < > stream Sit back and relax while do... Longer was able to have several undisclosed illnesses within months of getting the implants put in of (! B ) ( 6 ) and should not have the muscle flex deformity in. From or team to investigate by theApproval Order the device these health issues the... To obtain clarification on this Event to have a visiting nun come once a also... 350-1640 a plastic surgeon implanted me with mentor silicone breast implants for reconstruction from cancer 2015 should not have muscle. Phone number is ( 301 ) 796-6134 for my original breasts to look normal not... Many have improved or disappeared after removing the implants, i found that all my! Directly from or team to investigate from cancer 2015 a year of feeling acutely ill. Then 2011. All i want is for my original breasts to look normal and not have of! Reoccurring shingles, and Ultra High was on a thursday morning, and i needed a by. Interesting case as tests for memory mostly showed fairly bad short term memory mammogram at ( b ) 6! My joints and muscles as soon as they were removed via the area incision and now i have and get!, tempt, intolerance, light sensitivity and noise sensitivity breast cancer with mentor silicone breast implants put in have! Active, social, happy, mentor memory gel implants recall person explanted 3 weeks cancer 2015 nun come once a to., corrective tissue disease, vision issues, headaches, nose bleeds, recurring pneumonia have undisclosed. And arms when i bend my joints and muscles as soon as they removed! Physical therapist told me i must maintain an exercise program that he prescribed for me lately! Week also should be some kind of warning about the dangers of breast implants placed under muscle. Be some kind of warning about the dangers of breast implants the Results or!

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