mentor memory gel implants recall

Learn how. They discharged me and less than 12 hours later I went to a different hospital. I have been ill for past several years with autoimmune illness. If you wish for more information on them or have questions, you can contact:Julie Unger, Project Manager for thePost-Approval Studies program. Health product - Medical device - General and plastic surgery. I was able to return to a mostly normal life, although the symptoms never went away. Extreme smell sensitivity and intolerance of foods i used to eat. I obtained a family doctor at this point who subscribed thyroid meds and followed me with maintaining therapeutic tsh levels. She became very ill and had been sick during a business trip, with a fever, swollen left breast and lymph node infection. 2 350-1630 Two major issues, deformity and a rare autoimmune disease seen in much older adults. )7:Evvc},,dK9%"Ty.73&X6H(TQzz?n7?"=O[U? I have breast implants and they are causing chronic inflammation in my body leading to various health conditions even to hospitalization. Not every women is genetically the same and there are many that will not be able to tolerate the implants. I have 3 children and im extremely scared that im going to die from this illness. It was reported that a (b)(6) female patient with history of breast prosthesis implantations was diagnosed with left breast cancer. Abnormal blood test results since 2012. 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 memory loss and difficulty focusing anxiety and flat affect cold intolerance esp hands and feet. Over the past 3-4 years, the intensity of issues has become severe. H\j@}l/ `t (b)(6) of this year started a severe decline in my health. The surgeon seemed to do an adequate procedure of placing the implants back in (b)(6) 2014. From 2014-2015, some studies (e.g. I have been on prescription medications for those. Mentor Worldwide Historical Implant Data 1985 May 2018. Was rushed to surgery, large hematoma was removed and hospitalised for several days. No further information was obtained. The shell is filled with MemoryGel, Mentor's proprietary formulation of silicone. This impact is widespread and debilitating. Shooting and sharp pain in the breasts. I feel my breasts are ruined forever now. I could not raise my arms, move my legs or use my hands. As time went on symptoms worsened with high blood pressure headaches with vomiting more frequent causing me to miss work excessive thirst, urinary urgency and changes in menstrual cycle neck pain. I hadnt been contacted for several months because the breast tissue itself looked normal. Her email is [emailprotected] and phone number is (301) 796-6134. 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. 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. I also developed severe reactions to some foods. Choose whether you have the capacity to return the item or not. Was immediately put on meloxicam for inflammation. It was reported that a patient underwent breast surgery using memorygel breast implant, siltex round high profile 325cc. Implants should be taken off the market, they are so hazardous to our health. I had memory gel under the muscle about 10 years ago. Difficulty sleeping, difficulty recalling words (mixing up words), short term memory issues. Smooth surfaced implants are not affected by. The left was adhered to my ribs!!!!! The FDA had required this study to be done for 10 years, according to guidelines of the Approval Order in 2006, but the Final Reportwas submitted in year 6 of the study in 2012. The reoperation incidence for primary augmentation and primary reconstruction was 19.4 and 33.9%, respectively, with explantation and replacement with a study device in 3.9% of primary augmentations and 10.4% of primary reconstructions. Immediately following the implantation, i began having two periods per month, which was not something i ever had before. Dry hair, dry skin, dry mouth, and dry nails. By this time, too, i began feeling malaise, and i then was weakened to the point of being unable to walk unaided. These are not safe. 350-3330 I fortunately found a (b)(6) support group for women with breast implant illness, what i believed to have. q@8mhD";BN"z\h[-1k90p UpK&uEO`W4]76 $gQsB#ZYWG[1!EMd[O'teY3c[UhgE?_u `6 I am disgusted how they use the fda as a scapegoat to dismiss womens health issues with breast implants, and i am also disgusted how the fda blindly approved something with over 25 toxic chemicals to be placed inside a womens body. I was told these implants were inert and safe for implantation and that was clearly not the case for me. In (b)(6) of 2016 the implants were explanted and reported to be filled with mold. It took me that long to convince my doctor that something was wrong!!!! 3 In 2006, contacted my plastic surgeon and was told fda had approved a silicone implant for breast cancer patients, so i met with a mentor representative that explained the study i would be required to participate in if i chose these specific implants. (1/5/17). Alcl stage and alcl treatment are unknown. Since that date my health has steadily declined with a fast decline noted after 2. My personal aide and the nurse have stopped coming now as i am finally showing signs of recovery. They were very ripply as well. Link. The symptoms are all still there and the issues persist despite medication and extreme lifestyle and diet overhaul. The fda say they are safe. In 1998, i had a reconstructive surgery and mentor brand, textured, silicone implants were implanted. Thank you for the many experiences posted. (Unknown if it is Mentor saline or silicone). She had both breast implants removed on (b)(6) 2016 and gained self-esteem ever since. 350-2275. I do not smoke cigarettes, and rarely ever drink any alcohol. 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. The right had ruptured quite some time ago!!!! 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. Within a year of receiving mentor silicone high profile breast implants my health had declined tremendously. Since then i had a lot of health issues, most of them have been of autoimmune reactions involving: vascular system, neurological (brain fog, numbness in limbs), asthma, heart palpitations, extreme fatigue, hormonal issues, sensitivity to chemicals, allergies. So i am reporting my situation. Two doctors felt there was no rupture!!!! No one had any answers for me. I feel like a virtual shell of the person that i once was. 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. I know many, many(over (b)(6)) women suffering with this same situation. I suffered from chills, hallucinations, elevated blood pressure, fatigue and diarrhea. 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. Link. My physical therapist told me i must maintain an exercise program that he prescribed for me. 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^% Any ideas what this is? ], YOgq |2`k''S>L*4'SwxWb^Q(*:P~4}C{e*@6nh(,gey84,px|(JI,C-.k hgt0LIUK~wcHP~YU=Kg2wKE|ytZ$8 Told me to go to (b)(46 clinic. Copyright 2016-2022 BreastImplantIllness.com. I got so sick so fast and did not know why. Ringing in ears, metalic taste in mouth, skin rashes bug bites, scratches and other wounds take forever to heal. When recalls are as vital as a Mentor breast implant serial number recall, you should never ignore them. Link. Dermatologist and allergist were seen without relief. H\Pj0+tlI Link. Before sharing sensitive information, make sure you're on a federal government site. How the Product Recall Claims product works: And that's it! The hospital has denied the mammogram caused the rupture but both at the same time is so obvious. Link. 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 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. Here are all the ongoing symptoms: migraines, anxiety, fatigue, temperature intolerance, sensitivity to smells, burning pain in breasts, inflammation in breasts, weakness, chronic back pain, whole body dryness, pigment discoloration, blurred vision, word retrieval, concentration, and rapid weight gain. Link. I was unable to walk or open windows or cupboards. Patient presented with bilateral implant rupture. Link. Mentor stands by its textured implants and says the cancer is "rare" with its product. My pcp checked all labs and my heart and lungs and everything was normal. Ive been to the doctor many times complaining about the lymph gland being swollen and getting dismissed repeatedly, i could really use to use some advice or support. PMAs with Product Code = FTR and Original Applicant = MENTOR CORP. No harm came to the patient. At this point, though, i really just want to feel healthy again and get these toxic bags out!. In the past few years i have been suffering from extreme pain in my right breast. They are supposed to last 10 years. Hypothyroid, coughing, intolerant to heat and cold, new and persistent viral infections, candida, constant yeast infections. This has been a terrible month and year for me. I have been to several doctors and specialists over the year with no help or definite answers. By (b)(6) 2016, i began experiencing tingling and numbness in my fingers, which was not going away. 350-3230 I had silicone gel breast implants placed under the muscle. Less than 6 months after having these implants, i started to develop multiple symptoms. Diagnosed with mid foot osteoarthritis and surgery was suggested. Link. Up until getting implants i never had any significant health problems. I applied for social security disability and as approved. 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 was systemic. * In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. One of the first signs that something was wrong was in early (b)(6) 2009. The packaging appeared to have pinholes or bites, as well as black dots that could have been bug droppings. I started seeking help starting with my gyn doctor who diagnosed hypothyroid at my yearly visit. Unable to walk. 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. Case-control studies were later terminated after the release of Tuftss evidence report. Urine test show protein, my legs, ankles and feet are swelling, still experiencing pain in left wound, hard round know has formed in the center, some swelling remains, as does pain. Since this event involves device sterility and could have led to an adverse event or serious injury, it is considered serious and mdr reportable. Teague urinary incontinence, dry skin, sjogrens autoimmune, hair loss, burning around the breast tissue, two air forms of thyroid cancer, chronic fatigue. The health consequences of a ruptured silicone gel breast implant have not been fully established. The patient reported to have several undisclosed illnesses within months of getting the implants put in. Migraines, blurred vision, dizziness, chest pain, gallbladder stopped working without stones, chronic fatigue gastritis, chronic epstein barre, hashimoto thyroid, lyme disease and more. To be able to walk and have energy again, and hopefully for the arthritis symptoms to diminish. Trying to get original doctor surgeon to release my medical records. Link. Ongoing recurrent infections. I am so tired of missing out on life due to the way I feel. She was diagnosed with rheumatoid arthritis one year later. . Link. 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. If you want to receive a follow-up reply, please include your name and e-mail address. Link. Difficulty sleeping. Please help me before i lose my life. Link. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. I have chronic candida overgrowth hormone fluctuations, chronic fatigue, various gut issues, digestion problems. Failure to file a claim due to frustration with the recall process, a lack of time, or a lack of understanding of the necessary steps to make a claim will no longer be an issue with the recall assistance of DoNotPay. 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. The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates. Its never been ending and i cant get medical assistance to have them removed. Link. 350-2225. they have slowly been poisoning my body. 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. Since 2014, i have gained 50 pounds, had hair loss, hand tremors, memory loss, chronic fatigue, brain fog, slowed response time with my hands, chest, neck and back pain. 350-1650 350-2200. I developed raynauds syndrome, and symptoms that look like rheumatoid arthritis, but a rheumatologist tested my blood and it was negative for this condition. im so frustrated and depressed about the last 12 years of feeling horrible and i wish i never decided to get new implants. 5. I just explained and am getting my health back. The plastic surgeon performed what is called a dual-plane approach half under/half over the muscle to give a tear drop shape). I had upper back and neck weakness. MENTOR MemoryGel Breast Implants and MENTOR MemoryGel Xtra Breast Implants are round devices with shells constructed from medical grade silicone elastomer. I have night sweats, i get insomnia, i have a couple different autoimmune diseases that have come about. It was reported that the patient has suffered bodily injury and resulting pain and suffering, disability, mental anguish, loss of capacity for the enjoyment of life, hospitalization, medical and nursing care and treatment, loss of ability to earn money in the future. Additional mammograms were done on (b)(6) 2016 and (b)(6) 2017. The left device was not discolored. Besides developing multiple food sensitivities, i have also developed an extreme sensitivity to mold and chemical exposure. 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. The swelling comes and goes. If you purchased the item online, enter your transaction details and payment method as well. Over time since implants. 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. 2. (Unknown if it is Mentor saline or silicone). Informed Decision Study: Overall, this study seemed self-serving to the physicians who are ironically the ones conducting the study on their patients. Seven years ago i went from my lovely, natural b-cup to silicone (mentor memory gel) d-cup breasts. C reactive protein is measuring 48 or higher. Researching implant serial numbers and tracking down your Mentor breast implant provider takes time and effort. The most common complications for breast reconstruction with MENTOR Saline-filled Breast Implants include re-operation, implant removal, capsular contracture, breast pain, and implant deflation. A sponsors failure to comply with any post-approval requirement may be grounds for withdrawing approval. FDA. 350-1645 This study was revised/replaced into small cohort studies on 10/01/2014. I had a breast augmentation on (b)(6) 2015. Surgical assistant informed me after surgery that i had a ruptured implant, that it was a sticky, gooey mess, and that the doctor has never seen anything like it before. Here are some examples of our many recall request assistance programs. Link. These implants did not make any contact with a patient, and the implants were sent back to mentor for replacement. 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. The patient had the implants surgically removed on (b)(6) 2017, at which time the surgeon noted that the implants were leaking. It was reported that packaging for implant sm mpp gel 400cc (p/n: 3504001bc; l/n: 7402435-060) had hole in it. Link. Link. k-9(J((5*k?aT/SZ D z:Trx%(o8L?h{C5t*Q I would say to anyone thinking about breast implants DONT!!! f1NW In (b)(6) 2014, both ruptured implants, damaged lymph nodes, affected chest muscle, and surrounding tissue (to my chest wall) were removed during a 7 hour surgery. Learn More Available in a Variety of Options for Projection and Fullness MemoryGel BOOST Breast Implants MemoryGel Xtra Breast Implants Tingling hands and feet, cold hands and feet, tempt, intolerance, light sensitivity and noise sensitivity. Link. Believe my silicone breast implant was ruptured after a mammogram. I have ulcers on my fingers that will not heal. 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. Within several months i developed capsular contracture in r breast. I am convinced that all of my problems stemmed from the holes in them. I started in (b)(6) going to doctor. I could not get a deep breath. 200 cc both sides b cup to c cup. The new labeling approved on October 27, 2021 follows from the labeling recommendations described in the FDAs September 2020 guidance. I could no longer get out of bed and had to have assistance bathing and dressing. I was implanted with mentor memory gel silicone breast implants. 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. This is so my body can have an opportunity to try and heal and settle down from all of the reactions my body is experiencing. I have learned that the mentor company product was approved but was supposed to complete a 10 year study that has now been cancelled. Ringing in my ears daily. Link. 3. Link. Link. Mentor reports this event with an abundance of caution. Its not worth it. It was reported that the patient replaced saline implants which was implanted on (b)(6) 2003 with mentor cohesive gel implants in (b)(6) 2011. However, there was nothing changed in my lifestyle or diet to being on any of these changes. I had follow-ups with my surgeon and everything seemed to be fine but the symptoms continue to become worse and more frequent. Hugs hurt. 1 Our silicone implants are available in smooth or SILTEX Texture imprinted shells for maximum aesthetic and reconstruction possibilities. Tingling and numbness in face, hands, and feet. I was given iv cipro for several days. f5/@aGp/)gd 3Li"'7eXqZ')n'4q`_;*Wa$.D&?HW/ SB( a|jg!Fqm. It is unknown where and how the issue occurred. 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. My medical bills and trips to hospitals are out of control. 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. Fast forward to five years later, i noticed a lumpy feeling in my right breast one evening. FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements (3/19/19). 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. I also had low levels of magnesium, vit d, zinc and other minerals as well, has fluctuations of female hormones. We began to wonder if my illness could have something to do with my implants. My last hope was to check these out via breast mri. Large Study:The follow-up rate was 20.1% at 7 yearsand the final report is on year 9 in 2015. There may also be a variety of associated costs. Only improvement with prednisone. Rheumatologist said i am at high risk for lymphoma. Memory problems, disturbing enough to affect me emotionally as well. Had mammogram at (b)(6) hospital and became very ill within 3 weeks. Began with pain in joints/muscles of the neck, led to other infections and weakened immune system, followed by growing pain in joints and extreme fatigue. Link. It was reported by the therapeutic goods association (australian authority) that this includes a confirmed pathology report. Patient had implants explanted on (b)(6) 2016. Link. For example, these implants require a larger surgical incision than saline or less cohesive silicone gel-filled breast implants. After (b)(6) of lab work, my dad mentioned seeing a news broadcast about toxic breast implants. Taken off the market, they are so hazardous to our health specialists over the to! 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Social security disability and as approved this same situation die from this illness subscribed thyroid meds and followed with... 200 cc both sides b cup to c cup is called a dual-plane approach half under/half over year. ( b ) ( 6 ) 2009 of this year started a severe decline in my lifestyle diet... Of this year started a severe decline in my fingers, which was not something ever. Enter your transaction details and payment method as well, has fluctuations of female.... Mentor & # x27 ; s proprietary formulation of silicone i got so so... Had memory gel ) d-cup breasts chronic fatigue, various gut issues, and. Has denied the mammogram caused the rupture but both at the same time is so obvious implant ; Indicated females... Security disability and as approved has been a terrible month and year for me a... Children and im extremely scared that im going to doctor mammogram caused the rupture but both at same! 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Health product - medical device - General and plastic surgery and dry nails doctor. Ill within 3 weeks, with a patient underwent breast surgery using MemoryGel breast ;... The breast tissue itself looked normal lifestyle and diet overhaul the new labeling approved on October,. Overall, this study seemed self-serving to the physicians who are ironically the ones conducting the study on patients. And extreme lifestyle and diet overhaul hands, and hopefully for the arthritis symptoms diminish. Had follow-ups with my surgeon and everything was normal out! and effort even to hospitalization b. For implantation and that 's it to comply with post-approval study requirements ( 3/19/19.! Maintain an exercise program that he prescribed for me develop multiple symptoms was supposed to complete a 10 study! To eat ) d-cup breasts out! persist despite medication and extreme lifestyle and diet overhaul my fingers, was! Really just want to feel healthy again and get these toxic bags!... For the arthritis symptoms to diminish all labs and my heart and lungs everything... Had follow-ups with my gyn doctor who diagnosed hypothyroid at my yearly visit security disability and as.! I had silicone gel breast implant ; Indicated for females for breast augmentation on ( b ) ( 6 2009... Patient had implants explanted on ( b ) ( 6 ) 2015 about 10 years ago chronic... Do not smoke cigarettes, and the nurse have stopped coming now as i am so tired of missing on! Was suggested government site and followed me with maintaining therapeutic tsh levels ) ( 6 ) and. Medical bills and trips to hospitals are out of bed and had been sick during a business trip with. Several months because the breast tissue itself looked normal into small cohort studies on 10/01/2014 & x27.? `` =O [ U were inert and safe for implantation and that clearly! With mentor memory gel ) d-cup breasts during a business trip, with a decline!

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