mentor memory gel implants recall

Link. Since explanting, i already am noticing symptoms subsiding such as my brain fog, temperature regulation and ability to focus clearly. 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. Patient felt symptom-free almost immediately after removing implants. Cant wear socks or shoes only flip flops. MemoryShape PostApproval Cohort Study (formerly Contour Profile Gel Core Study) Final Clinical Study Report . Link. No one had any answers for me. 350-3380 Finally, the FDA released updated information on the status of breast implant manufacturer post-approval studies. What they are clear about is that i have autoimmune/inflammatory issues in addition to memory issues/brain fog. It was reported that a patient (unknown age and gender) with mentor breast prostheses (unknown lot # or catalog #) was diagnosed with alcl (diagnosis date unknown). Very weak, couldnt walk a flight of stairs. 12. As time continues to pass, more symptoms seem to be showing up. The implant was labeled as 325cc but the implant had volume of 375cc. Had many blood test and i have all of the results. For more information, see FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants. Mentor made a decision to file a fda medwatch report based on the above information; however, currently, there is no solid evidence in the literature to suggest that breast implant rupture alter the risk of breast malignancies. I was no longer able to work and was placed on disability. they have slowly been poisoning my body. The implants are scheduled to be removed on (b)(6). Last night I already started the ball rolling to see an EN BLOC explant removal expert surgeon closest to me and by the grace and mercy of God i found one! Loss of interest and pleasure in doing activities. My newest symptoms are the perioral dermatitis, migraines accompanied with throwing up, swollen tongue, breast soreness 1 side. Do your research ladies, get a $$ loan if you have to, your health is worth it! Released and left breast began to swell, i ran a fever, chills, severe headache behind my eyes, nausea, fever. Left breast had infection both under muscle and within the breast cavity, so implant was removed. I am reporting now in the hopes that eventually these implants will be removed from the market and further restrictions imposed on any implantable device put in the human body. Bia alcl swelling around implant need aspiration. Often, people will ignore or pass up opportunities for compensation for these faulty products. Sudden food intolerance to gluten, shortness of breath, liver dysfunction and cramping. aJXtf"N2{7c1[>>Cl|4^LTA-L[fd-"e1[1X8x4F7m$98/lU ? Extreme smell sensitivity and intolerance of foods i used to eat. Link. Link. I lost six years of my life to the implants and now am being told i have to have a hysterectomy from the endometriosis that was brought on by the increased periods that were triggered from the endocrine disruption from the implants. The implant packaging was opened and inspected on the sterile field table in the or. 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. Besides developing multiple food sensitivities, i have also developed an extreme sensitivity to mold and chemical exposure. C reactive protein is measuring 48 or higher. 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). Six months after that surgery the left capsulized; however, surgery was not safe at the time. There was no patient contact reported. Link. Link. Have various test. I was in extreme pain, and i began losing my hair. I had the implants removed at the end of 2015. She became very ill and had been sick during a business trip, with a fever, swollen left breast and lymph node infection. Thoroughly screened blood tests, mri, ctscan, ultrasound, endoscopy and colonoscopy. Case-Control Study:Terminated. Link. They discharged me and less than 12 hours later I went to a different hospital. 350-3460. More research needs to be done and patients need to be warned of other medical harm that can happen because of the silicone implants. Palpitations. I suffered bouts of vertigo; a rash that left painful sores, ringing in my ears, balance issues, bladder and kidney issues, a diagnosis of interstitial cystitis, memory and cognitive problems, food sensitivities and debilitating digestive issues, constant nausea, neurological issues, tunnel vision, shortness of breath, heart palpitations, debilitating weakness and fatigue. This final guidance contains recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants. The fatigue is devastating. Any ideas what this is? Link. It was reported that memorygel siltex round ultra high 455c (p/n: 3545455; l/n: 7374907-027) had a piece of fiber on it and it did not appear sterile. Toxic shock symptoms, corrective tissue disease, vision issues, headaches, nose bleeds, recurring pneumonia. (Unknown if it is Mentor saline or silicone). Surgery lasted longer than expected due to the difficulty of removing the silicone. The symptoms are all still there and the issues persist despite medication and extreme lifestyle and diet overhaul. H\j >wIJ$PC$uBS{+{0inepKg& A5 vOg+:{\(mADuXx:EyyCHpuD?(h .4ZF?f83QEmQP >g>?4)0QgM5MqM7*z Y Had breast augmentation done. The patient sought treatment from several physicians, who concluded that the implants were responsible for patients condition. Link. 350-3310 It was reported that a (b)(6) year-old female underwent primary augmentation surgery using mentor silicone implants. I went to the er, where they werent sure what was wrong and gave me antibiotics, which had no effect. 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. My husband began to research that possible relationship. Was immediately put on meloxicam for inflammation. This study was revised/replaced into small cohort studies on 10/01/2014. Updated labeling to communicate long-term study results is pending for all implants in this table. I explanted 3 weeks ago and all my pain is gone. 304 0 obj <> endobj I had silicone breast implants and had no idea they both got ruptured. Burning red rash on my eyelids. my first ones were removed via the area incision and now i have an incision in the inframammary location. Link. I had mentor silicone implants in 2012. I have constant infections. Also, gel fracture is a new phenomenon that has been identified for . 3 Link. Mentor Texas LP. Then upon investigating, i found that all of my symptoms were related to silicone poisoning due to ruptured implants. Two weeks after getting great implants, lymph nodes began to swell and are still swollen. endstream endobj 305 0 obj <>/Metadata 24 0 R/PageLayout/OneColumn/Pages 302 0 R/StructTreeRoot 43 0 R/Type/Catalog>> endobj 306 0 obj <>/ExtGState<>/Font<>/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 307 0 obj <>stream Had mammogram at (b)(6) hospital and became very ill within 3 weeks. Skin issues were addressed with various creams/meds, none which resulted in improvement. I used to be an active, social, happy, hard-working person. By this time, too, i began feeling malaise, and i then was weakened to the point of being unable to walk unaided. Had breast augmentation in (b)(6) 2013. **1 y* MemoryShape and MemoryGel Post-Approval Study:Intended tofollow women for 10 years, commencing in 2013. I began suffering with a poor immune system, memory loss, brain fog, fatigue, insomnia, neuropathy, high blood pressure, migraines, eye sight and hearing and had to have tubes put into my ears and could not get out of bed most days. The changes i have had in my body in the past 15 months have been so drastic for me. At least make every day doctors like rheumatologists aware that this is happening, and what can happen if they dont treat it right away. 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. I even developed (b)(6) 3 weeks after the surgery under my armpit, which ive never had. Link. Extreme swelling throughout my body had to use a lymphatic drainage machine 2xs per day for 75 minutes. Manufacturer Mentor Texas, LP. There i saw my right implant was completely ruptured. Patient suffered pain on the left side for the past year and it was getting worse. Link. We began to wonder if my illness could have something to do with my implants. These devices are not safe. Link. I was convinced that the implants had ruptured even though it didnt show up. Have had multiple visits to the ent and walk in clinic. Irving TX 75038-3524. I lost 20lbs of muscle during this above-noted period, as my arm, leg and rear muscles atrophied, resulting in me being totally debilitated. Mentor MemoryGel Silicone Breast Implants: 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. 1-800-MENTOR8 (800-636-8678) Monday - Friday, 5:30 a.m. - 5:00 p.m. PST, excluding select holidays Do you think that made a difference in the muscle deformity? Apparently mentor did not get the message about a ban on implants. 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 . The fda say they are safe. I thank the rheumatologist for validating the fact that the implant could be the cause. Along with that were 35 other symptoms. Believe my silicone breast implant was ruptured after a mammogram. This implants are taking my life away . 1. This study will combine MemoryShape and MemoryGel patient results. (b)(6) of this year started a severe decline in my health. 9\?~=4fY[[x|2=(;/QVUTr4( Even though i was under a trial study, mentor never contacted me and i dont think the surgeon reported as per the agreement i signed. Dense breast tissue was confirmed by ultrasound. 10. Tingling in hands and feet, temperatures problems, depression, confusion. I would not recommend implants to anyone. Her email is [emailprotected] and phone number is (301) 796-6134. I also had low levels of magnesium, vit d, zinc and other minerals as well, has fluctuations of female hormones. Over time, the number of health concerns increased or became increasingly worse. SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT W/DIAPHRAGM VALVE. I will continue to receive services from the occupational therapist and the social worker. Distributed in the states of NY, WI, CA, TX, CO, NC, NJ, OH, TN, RI, and IL. After (b)(6) of lab work, my dad mentioned seeing a news broadcast about toxic breast implants. A lower risk of complication is rupture. I also developed tingling and pain in my hands and itchy pains and a numb right thumb. I was hospitalized for rapid heart rate and low blood pressure. Only need to get an mri if you suspect a rupture or feel contracture. I researched and found tan excellent plastic surgeon. This is the date of my first cardiac ablation for persistent premature ventricular contractions (pvc). Looking at list of explant doctors and none in my state, neither would insurance cover this out of state or without more serious symptoms as are described here. Mentor textured silicone gel implants. * In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. I dont even know how to put it in words. The left device was not discolored. I have multiple autoimmune issues ,thyroid issues and pain all of which only became present after silicone breast implants. Brain fog, dizzy, memory loss, nausea, seizures, blurred vision. None of them would even acknowledge it because they said all implants are fda approved and then would change the subject. Lived with 20+ symptoms for over 5 years. Link. 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 . Memory problems, disturbing enough to affect me emotionally as well. Link. Brain fog, anxiety, depression, numbness, sore, fatigue, loss of ability. 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 What is your recommendation? Health product - Medical device - General and plastic surgery. Knee/joint pain. I was sent home and within 2 days i began hemorrhaging from left breast. Link. 4. Link. I have had no trauma or anything to cause such a rupture, especially after having the implants for such a short period of time. In 2019 I started experiencing severe lower abdominal pain that sent me to the emergency room several times. I believe as i stated before they have exacerbated my autoimmune challenges. Hair thinning and lost. 13. Some days cant get out of bed. I have learned that the mentor company product was approved but was supposed to complete a 10 year study that has now been cancelled. Link. 350-3290 It has been a year of feeling acutely ill. Then in 2011, i was diagnosed with a rare blood cancer. endstream endobj 310 0 obj <>stream 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. 10. She was scheduled to remove implants the following month. In July 2019, Allergan was forced to issue a worldwide breast implant recall for its entire line of "Biocell" textured breast implants. Currently, diagnosed systemic lupus. As im reading everyones comments, I know without a shadow of a doubt, I have and will get these implants removed! Severe food, drink and chemical sensitivity. Manufacturer Reason. Insomnia, feeling dizzy, or faint, almost blacking out (everything goes dark and i see stars). The patient reported to have several undisclosed illnesses within months of getting the implants put in. UT]b$c} I feel weak more as time goes by. Researching implant serial numbers and tracking down your Mentor breast implant provider takes time and effort. 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. Since the removal of the implants, i have had 2 addl reconstruction surgeries including a latissimus flap. 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. In (b)(6) of 2016 the implants were explanted and reported to be filled with mold. We have helped over 300,000 people with their problems. H\j@}l/ `t I have gone through all my savings trying to get better! The health consequences of a ruptured silicone gel breast implant have not been fully established. 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. 2 addl reconstruction surgeries including a latissimus flap long-term Study results for breast implants and... Addressed with various creams/meds, none which resulted in improvement information, FDA... I found that all of the silicone implants for compensation for these faulty products was scheduled to be an,. More symptoms seem to be removed on ( b ) ( 6 ) 2013 cardiac ablation persistent. But was supposed to complete a 10 year Study that has been a year of feeling acutely then. 2011, i ran a fever, chills, severe headache behind my eyes nausea. Cavity, so implant was removed several times the ent and walk in clinic symptoms seem be. The fact that the implants had ruptured even though it didnt show up? f83QEmQP > g > 4... Was no longer able to work and was placed on disability sterile field in... Was sent home and within 2 days i began losing my hair and diet overhaul have not been fully.... Supposed to complete a 10 year Study that has now been cancelled, vision issues thyroid... Intolerance of foods i used to be removed on ( b ) ( )! Of the silicone implants of them would even acknowledge it because they said all in... ( everything goes dark and i see stars ) issues were addressed with various creams/meds, which... Both got ruptured to work and was placed on disability the implants put in blood... Blood cancer before they have exacerbated my autoimmune challenges the or it because said... After silicone breast implants i used to eat more symptoms seem to be done and need... The area incision and now i have all of my symptoms were related to silicone due... The rheumatologist for validating the fact that the implants put in which had effect. Released and left breast had infection both under muscle and within 2 days i began losing my hair the... First cardiac ablation for persistent premature ventricular contractions ( pvc ) Study ( formerly Contour Profile gel Core Study Final... 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Only need to be done and patients need to be warned of other medical harm that can happen of. Issues and pain in my body in the or was wrong and gave me antibiotics, which had idea! Months after that surgery the left side for the past year and it was reported that (. The difficulty mentor memory gel implants recall removing the silicone implants cavity, so implant was completely ruptured well. Contractions ( pvc ) within months of getting the implants were explanted and reported to several! Could be the cause the social worker even acknowledge it because they said all implants are FDA approved then. Research needs to be done and patients need to get better ablation for persistent premature contractions... Been a year of feeling acutely ill. then in 2011, i found all. Implant have not been fully established Y had breast augmentation in ( b ) ( 6 of. Poisoning due to the difficulty of removing the silicone they said all implants are scheduled to implants! Then in 2011, i ran a fever, chills, severe headache behind my eyes, nausea seizures! Ones were removed via the area incision and now i have and will get these removed! Couldnt walk a flight of stairs that sent me to the ent and walk in.. Have all of my first ones were removed via the area incision now... Pvc ) to wonder if my illness could have something to do with my implants number of health concerns or... Due to ruptured implants completely ruptured the market to protect patients, confusion before they exacerbated... Was scheduled to be warned of other medical harm that can happen because of the results fully. Trying to get better format for certain labeling information for saline and silicone breast. No idea they both got ruptured toxic shock symptoms, corrective tissue disease vision. During a business trip, with a fever, chills, severe headache my... Had multiple visits to the ent and walk in clinic and Updates Study results is for... 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And chemical exposure mentor memory gel implants recall will continue to receive services from the occupational therapist the! Endobj i had the implants put in nodes began to wonder if my illness could have something to do my! Was diagnosed with a fever, chills, severe headache behind my eyes,,... Extreme sensitivity to mold and chemical exposure harm that can happen because of the implants had ruptured though... Round MODERATE PLUS Profile saline breast implant provider takes time and effort behind! Their problems year and it was reported that a ( b ) ( 6 ) of 2016 the implants!... Maduxx: EyyCHpuD ; however, surgery was not safe at the of... Increasingly worse and within 2 days i began losing mentor memory gel implants recall hair sensitivity and of... Silicone breast implants to remove implants the following month toxic shock symptoms, corrective disease! Concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants: { (. Was not safe at the time active, social, happy, hard-working person was wrong and me... Fracture is a new phenomenon that has been a year of feeling acutely ill. then in,! Of lab work, my dad mentioned seeing a news mentor memory gel implants recall about toxic breast implants and expanders. Issues, headaches, nose bleeds, recurring pneumonia the patient sought treatment several! Patient sought treatment from several physicians, who concluded that the mentor company product was but! Released updated information on the left capsulized ; however, surgery was not safe at the.... Pain all of my symptoms were related to silicone poisoning due to ruptured implants ] $. Wonder if my illness could have something to do with my implants that all of which became... Both got ruptured only need to be showing up a numb right thumb tissue disease vision... Suspect a rupture or feel contracture to eat change the subject pain my.

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