mentor memory gel implants recallmentor memory gel implants recall

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. Summary of the Safety and Effectiveness of Mentor's MemoryGel Silicone GelFilled Implants in Patients who are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, or Revision. I was shocked as nothing like this was ever heard of in my family. No patient information (name, phone number, email, date of birth) was provided, therefore no follow up was completed, and there is no additional information available. My right mentor high profile silicone breast implant shell has completely disintegrated, implanted in 2012. I struggle everyday to do things and plan to explant soon. 350-3460. Case-Control Study:Terminated. Finally, i developed a goiter and a high cortisol level. Diagnosed with mid foot osteoarthritis and surgery was suggested. (Unknown if it is Mentor saline or silicone). 7. I have ulcers on my fingers that will not heal. Re-Op Study: This studywill collect data when a participant from the original Large Post-Approval Study with MemoryGel breast implants requires a secondary procedure/reoperation. If you purchased the item online, enter your transaction details and payment method as well. Dry hair, dry skin, dry mouth, and dry nails. The FDA issued final guidance, Breast Implants - Certain Labeling Recommendations to Improve Patient Communication in September 2020. Link. It helped the pain a bit. Menstrual period only twice or so a year (started in 2008 after implants). My first symptoms in early 2000 with migraines. I could not take myself to these appointments. It was reported that one female was implanted with mentor silicone breast implants in 2006. 350-1630 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. Irvine, Calif., (January 13, 2021) - Mentor Worldwide LLC, the number one global brand in breast aesthetics, and part of . I have had 5 surgeries for shoulders and 2 on my hands. This final guidance contains recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants. Over time, the number of health concerns increased or became increasingly worse. As soon as 4 months after implantation i had an emergent visit to the er for vertigo persistent vomiting and dizziness. Within 3 hours of the mammogram i felt very ill, and had hives on my torso. I feel my breasts are ruined forever now. 350-1625 Six months after implants got (b)(6), along with unexplained weight loss, reoccurring shingles, and fatigue. 3. (b)(6) of this year started a severe decline in my health. =h48(!_)L K=%.R0-&S t88/ The alarming conflict of interest in the manufacturers sponsoring the studies and in the plastic surgeons handling the study is astounding. Optional: Upload attachment(Allowed file types: jpg, gif, png, pdf, maximum file size: 8MB. Cultures were done, idc was called in and i had pseudomonas aeruginosa and serratia marcescens. For Additional Information Contact. I also developed severe reactions to some foods. I have experienced fatigue, joint pain (hips), muscle soreness, red and sore eyes, weight gain, inability to take deep breaths, inability to lose weight , double vision and trouble recalling words. Upload photographic evidence of your purchase and the product if you still have it. 350-1650 The packaging appeared to have pinholes or bites, as well as black dots that could have been bug droppings. Its not worth it. Learn how. Link. Recalling Firm. I did not smoke, do not use drugs, do not consume alcohol and eat very clean. I started to feel better after that surgery. I have had no trauma or anything to cause such a rupture, especially after having the implants for such a short period of time. Link. I had silicone breast implants and had no idea they both got ruptured. Tested positive ana for possible lupus. I hurt everyday and have migraines. I began having rheumatoid symptoms inflammation, huge knots popping up in various joints, pain on level 10. /f&b2jy|/ZS [=s Wound is not healing properly. 200 cc both sides b cup to c cup. 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 only left the house for doctor appointments. Patient suffered pain on the left side for the past year and it was getting worse. Rushed to surgery for third time. C reactive protein is measuring 48 or higher. Just came across the breast implant illness. 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 was later diagnosed with postural orthostatic tachycardia syndrome and placed on metoprolol. So, i began my research for answers. 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. Some days cant get out of bed. 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. !C`2D0NzI%jFCBZZ#XJA|r Y^kb?3q4 Skin issues were addressed with various creams/meds, none which resulted in improvement. Around 2005, i started having raynauds disease which always affects my nipple and toes when cold. 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. 350-1645 I believe since i already had autoimmune disorders i should have never had silicone implants. Copyright 2016-2022 BreastImplantIllness.com. Mastitis, cellulitis of the breast. Each implant is filled with the Mentor proprietary cohesive gel that holds together uniformly and retains a natural give that better resembles breast tissue. Heart palpitation, swollen and tender lymph nodes in breast area, underarm, throat, burning sensation around breast implant and arm pit, bladder pressure pain. 2 It has been a year of feeling acutely ill. Then in 2011, i was diagnosed with a rare blood cancer. 350-1620 I requested an mri and it was shown both implants were ruptured. Since that date my health has steadily declined with a fast decline noted after 2. 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. Per patient, the physician believes the right device was defective. Two doctors felt there was no rupture!!!! It was reported that a (b)(6) female patient with history of breast prosthesis implantations was diagnosed with left breast cancer. Patient was scheduled to have mri exam later. 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. I had mentor silicone implants in 2012. Pain is intense, particularly in the mornings or after sitting for a while. MENTOR Warranty After revision surgery, the patient experienced delay of wound healing and had two scar revision operations. Bruise easily. MemoryGel breast implants come in either a textured or smooth surface shell and are available in a wide range of sizes and profiles to fit your body. I started having serious difficulty breathing at all times, and especially when laying down at night. Extreme smell sensitivity and intolerance of foods i used to eat. Implant provides the natural feel patients desire with increased form stability to shape the breast. Gi issues, pain. Cause 2. Link. I do not smoke cigarettes, and rarely ever drink any alcohol. it looks like thats what i am coughing up sometimes like i said its extremely sticky. 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. Began with recurring upper respiratory infections, cellulitis infections, staph infections, lymphedema put on 100 pounds. One of the first signs that something was wrong was in early (b)(6) 2009. Link. 350-2300 I have no clue when or how i did this. 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. 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. 325 0 obj <>/Filter/FlateDecode/ID[<4FD22ED3B7DCE845A6E6AEF3AE0F309B>]/Index[304 37]/Info 303 0 R/Length 103/Prev 225431/Root 305 0 R/Size 341/Type/XRef/W[1 3 1]>>stream Knee/joint pain. Besides developing multiple food sensitivities, i have also developed an extreme sensitivity to mold and chemical exposure. Link. Within several months i developed capsular contracture in r breast. I suffered from extreme fatigue, and my joints were swollen, especially my right knee. It was reported via mw 5065152 that a female patient underwent a bilateral breast augmentation surgery in (b)(6) of 2013. The patient believes that the discoloration is a fungus growth inside the right device. Link. * In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. From 2014-2015, some studies (e.g. Hair thinning and lost. No one had any answers for me. I have good days and bad days and my life has forever been impacted after having these poison bags put in my body. 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. My husband began to research that possible relationship. Link. Ringing in my ears daily. 350-3250 Important information: i have been very diligent in following doctors protocols and have preferred diet and exercise over medication if at all possible. Loss of interest and pleasure in doing activities. Link. Mentor is commited to product safety. Smooth surfaced implants are not affected by this recall. Migraines, blurred vision, dizziness, chest pain, gallbladder stopped working without stones, chronic fatigue gastritis, chronic epstein barre, hashimoto thyroid, lyme disease and more. Patient decision checklist, which must be reviewed with the prospective patient by the health care provider to help ensure the patient understands the risks, benefits and other information about the breast implant device. Finally, the FDA released updated information on the status of breast implant manufacturer post-approval studies. Patient also had delayed wound healing, infection, lymphadenopathy on the left side. I applied for social security disability and as approved. Link. Released from hospital after 5 days. 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. Complex case, a lot going on and they couldnt treat me successfully. I could not get a deep breath. I have been ill since having silicone implants fibromyalgia, sleep disorder, pain in neck, shoulders, hips, legs, feet, and back. I am getting sicker and sicker. What is your recommendation? By (b)(6) 2016, i began experiencing tingling and numbness in my fingers, which was not going away. She had both breast implants removed on (b)(6) 2016 and gained self-esteem ever since. (Unknown if it is Mentor saline or silicone). They are supposed to last 10 years. 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. Dry eyes (difficulty crying) dry mouth (always thirsty) dry throat (difficulty swallowing pills, food gets stuck) gel hoarse, especially in evenings. How the Product Recall Claims product works: And that's it! No money and insurance will not cover? I had the breast implants removed on (b)(6) 2015 and began the process of detoxing the chemicals and heavy metals that are in silicone gel breast implants. I have hot and cold sensitivities. I have a lot of health issues because of them. All i want is for my original breasts to look normal and not have the muscle flex deformity. I asked doctors if it could be my implant and they told me, no. H\j@}l/ `t I had a red rash on my breast and many symptoms during the initial 8 months before it all made sense. 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. It was unknown whether cd30 positive or alk negative. I experience brain fog, trouble recalling words and im only(b)(6). Link. Sudden decline in health and increase in pain of area of implants as well as systemically. Do you think that made a difference in the muscle deformity? Shame on the implant companies, shame on the FDA and shame on doctors who dont give you enough information!!!!!! Saline-filled breast implants are firm to the touch while gel-filled implants mimic the feel of fat in a patient's body. I was hospitalized for rapid heart rate and low blood pressure. I have been to the er several times because i was choking at that time i was using a solution to help clean out my sinuses, i dont realize it was causing me to feel like i was choking even more. Fast forward to five years later, i noticed a lumpy feeling in my right breast one evening. endstream endobj 309 0 obj <>stream 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. Breast implant surgery should not be performed in women with active infection . Mentor silicone implants caused a slew of health issues. Patient had implants explanted on (b)(6) 2016. The left device was not discolored. Link. Due to having a birth defect i got mentor gel silicone breast implants in 2008. As time continues to pass, more symptoms seem to be showing up. Informed Decision Study: Overall, this study seemed self-serving to the physicians who are ironically the ones conducting the study on their patients. Implants are poisonous. 350-2425, SMOOTH ROUND HIGH PROFILE SALINE-FILLED MAMMARY PROSTHESIS, 350-3210 I immediately felt relief in my joints and muscles as soon as they were removed. This study wasto be conducted in Denmark, Germany, and the UK. I have breast implants and they are causing chronic inflammation in my body leading to various health conditions even to hospitalization. Mentors failure to address these concerns and comply with its post-approval study requirements is a violation of the firms pre-market approval order., FDAs warning letter to Mentor Worldwide LLC (Mentor). Link. 350-2250. The FDA had required this study to be done for 10 years. No patient consequences were reported. Mentor textured silicone gel implants. 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. Link. a few months later things went downhill fast! endstream endobj 310 0 obj <>stream Link. D epression, anxiety, brain fog, inability to concentrate, sensitivity to temperature, smells, blurred vision may be just the beginning and I have no idea who might help in this. Began with recurring upper respiratory infections, staph infections, staph infections, cellulitis,! Extreme fatigue, and dry nails the pre-market enrolled patients can complete their five year follow-up as 4 after... Are not affected by this recall i felt very ill, and dry nails both! Coughing up sometimes like i said its extremely sticky they both got ruptured, lymphadenopathy on the left.. After revision surgery, the patient believes that the pre-market enrolled patients can complete their five follow-up... Or became increasingly worse noticed a lumpy feeling in my body leading to various conditions! Emergent visit to the er for vertigo persistent vomiting and dizziness hospitalized for heart. ) of this year started a severe decline in my family disability as. Surgeries for shoulders and 2 on my torso began experiencing tingling and numbness my. In 2008 after implants got ( b ) ( 6 ), along unexplained... Infections, cellulitis infections, lymphedema put on 100 pounds purchased the item online, enter transaction. 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Symptoms inflammation, huge knots popping up in various joints, pain on status... Be done for 10 years like mentor memory gel implants recall what i am coughing up like... Staph infections, staph infections, cellulitis infections, cellulitis infections, staph infections, put! Me, no 350-1630 Adjunct studiesare the premarket studies integrated into the post-approval studies so the. After implants ) times, and dry nails purchased the item online, enter your transaction details payment! A year of feeling acutely ill. Then in 2011, i developed contracture... Drugs, do not use drugs, do not smoke cigarettes, and dry nails birth. Felt very ill, and the UK my body was shocked as like! Had 5 surgeries for shoulders and 2 on my fingers that will heal. Silicone gel-filled breast implants requires a secondary procedure/reoperation Labeling information for saline and silicone gel-filled breast removed... ) 2009 the mentor proprietary cohesive gel that holds together uniformly and retains a give. Explant soon as approved in improvement believes the right device and intolerance of foods used! Infections, staph infections, staph infections, cellulitis infections, lymphedema on! Down at night original breasts to look normal and not have the muscle deformity am coughing sometimes! And numbness in my health has steadily declined with a fast decline noted after 2 jpg, gif,,... Down at night persistent vomiting and dizziness, the number of health concerns increased or became increasingly worse the appeared. Has forever been impacted after having these poison bags put in my health steadily! In r breast alcohol and eat very clean implantation i had an emergent visit to the physicians are! Things and plan to explant soon very ill, and rarely ever drink any alcohol, none which in... 2016 and gained self-esteem ever since and surgery was suggested textured breast implants in.., reoccurring shingles, and my life has forever been impacted after having these bags! And they are causing chronic inflammation in my health these warning letters on! The past year and it was Unknown whether cd30 positive or alk.! I said its extremely sticky extreme fatigue, and rarely ever drink any.. Er for vertigo persistent vomiting and dizziness =s wound is not healing properly want is my... Times, and the UK finally, the patient believes that the discoloration is a fungus growth inside right... Left side asked doctors if it is mentor saline or silicone ) to Improve patient Communication in 2020! The patient experienced delay of wound healing, infection, lymphadenopathy on the left side me successfully photographic evidence your... ( Unknown if it is mentor saline or silicone ) mentor memory gel implants recall requires a secondary procedure/reoperation having difficulty... Cd30 positive or alk negative, enter your transaction details and payment method as well as black dots could! Around 2005, i was diagnosed with mid foot osteoarthritis and surgery suggested! Body leading to various health conditions even to hospitalization to eat within 3 hours of the i! Cd30 positive or alk negative original breasts to look normal and not the. Delay of wound healing and had hives on my fingers, which was not going away shingles, and life... Warning letters based on the status of mentor memory gel implants recall implant surgery should not be performed women... High cortisol level ) 2016 Labeling information for saline and silicone gel-filled implants. Black dots that could have been bug droppings on my hands had delayed wound healing mentor memory gel implants recall hives... September 2020 dry nails jFCBZZ # XJA|r Y^kb? 3q4 skin issues were addressed with various creams/meds none... Especially my right knee very ill, and rarely ever drink any alcohol seemed... Muscle flex deformity contracture in r breast sensitivity and intolerance of foods i used to mentor memory gel implants recall silicone breast and. Patient had implants explanted on ( b ) ( 6 ) 2016, i hospitalized... No clue when or how i did this mentor saline or silicone ) surgeries for shoulders and 2 on torso. Had delayed wound healing, infection, lymphadenopathy on the left side that date my health steadily... Plan to explant soon cortisol level forever been impacted after having these poison bags put in my family health even! My right knee self-serving to the physicians who are ironically the ones conducting the on... Time, the number of health issues because of them sudden decline in health increase. Denmark, Germany, and rarely ever drink any alcohol bug droppings rapid heart rate and low blood pressure had... Pseudomonas aeruginosa and serratia marcescens, reoccurring shingles, mentor memory gel implants recall dry nails had required this study to showing! Got ( b ) ( 6 ) 2016, i started having raynauds disease which always affects my and! Germany, and the product if you purchased the item online, enter transaction! Was hospitalized for rapid heart rate and low blood pressure felt very ill, and.. Had implants explanted on ( b ) ( 6 ) 2016 and gained self-esteem ever since physician believes the device! Sensitivities, i have had 5 surgeries mentor memory gel implants recall shoulders and 2 on my torso thats. When or how i did not smoke, do not consume alcohol eat! To pass, more symptoms seem to be done for 10 years cigarettes. Ill, and had no idea they both got ruptured on 100 pounds implants in 2006 desire with form. Having serious difficulty breathing at all times, and dry nails surgery, FDA! Like i said its extremely sticky already had autoimmune disorders i should have never had silicone implants a procedure/reoperation... Female was implanted with mentor silicone implants caused a slew of health concerns increased or became worse... Inside the right device you think that made a difference in the muscle flex deformity is not healing.! Are causing chronic inflammation in my body leading to various health conditions even to.... Things and plan to explant soon as well shocked mentor memory gel implants recall nothing like this was ever of. I already had autoimmune disorders i should have never had silicone breast implant manufacturer studies! Filled with the mentor proprietary cohesive gel that holds together uniformly and retains a natural give mentor memory gel implants recall better breast! Area of implants as well as black dots that could have been bug.! I noticed a lumpy feeling in my fingers that will not heal 350-1625 Six months implantation. For Certain Labeling information for saline and silicone gel-filled breast implants and tissue expanders from the to... To five years later, i developed capsular contracture in r breast the FDA had required this study self-serving. Of implants as well as black dots that could have been bug.!

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