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. 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. r2c=nf"{*!5;/[{8F7)/Z}}o_=T*u 4+ )Z9B Polycythemia vera rubra. No deflation were found on both devices. In (b)(6) of 2016 the implants were explanted and reported to be filled with mold. Hugs hurt. 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. Link. How the Product Recall Claims product works: And that's it! 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. Bia alcl swelling around implant need aspiration. Immediately and every day since my surgery 3 weeks ago, ive had all of the same symptoms reappeared but even worse. After (b)(6) of lab work, my dad mentioned seeing a news broadcast about toxic breast implants. It was reported that a (b)(6) female patient underwent breast augmentation revision with mentor gel device on (b)(6) 2011. Implant provides the natural feel patients desire with increased form stability to shape the breast. It took me that long to convince my doctor that something was wrong!!!! A plastic surgeon implanted me with mentor memory gel silicone breast implants. I even contacted mentor and the fda via email before and neither seemed to care. I had developed severe food allergies and a few other symptoms about a year prior to the rupture, but thought nothing of it. I have been diagnosed with sjogrens, myalgia, low c4 and anemia. I am tired all the time despite excellent diet and plenty of exercise. I had mentor silicone breast implants in (b)(6) 2007. SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT W/DIAPHRAGM VALVE. I have multiple autoimmune issues ,thyroid issues and pain all of which only became present after silicone breast implants. 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. Conclusions: Mentor MemoryGel Silicone Breast implants represent a safe and effective choice for women . FDA Documents: Approval Date: November 17th, 2006 Recalls From that time on, i developed more and more symptoms that piled on top of each other. Dry eyes, blurred vision, double vision, and eye pressure. Difficulty healing (wound etc. ) Over the past 3-4 years, the intensity of issues has become severe. I was given iv cipro for several days. I have been sick for 5 yrs out of the 6 yrs I have had them and getting worse with time. I was able to have a visiting nun come once a week also. Link. 200 cc both sides b cup to c cup. I come from a long line of healthy people who mostly live into their nineties. My right mentor high profile silicone breast implant shell has completely disintegrated, implanted in 2012. Brain fog, memory loss, muscle pain, weakness, joint pain, dizziness. 350-3310 I am having a had reaction to my mentor silicone memory gel implants that were placed under the muscle three years ago. Consumers are regularly alerted to product recalls thanks in part to the Consumer Product Safety Act. Link. (Unknown if it is Mentor saline or silicone). Two major issues, deformity and a rare autoimmune disease seen in much older adults. =h48(!_)L K=%.R0-&S t88/ For the most part I'm pleased with how they look but unfortunately I'm having the implants removed in two weeks due to autoimmune reactions to them. As soon as 4 months after implantation i had an emergent visit to the er for vertigo persistent vomiting and dizziness. On (b)(6) 2009 is the date i had surgery to have implants. Medical Device Recall of MENTOR Smooth Round Saline DV Breast Implants Page 1 of 6 Event #7209. I know it was the implants pushing on my chest, probably due to the capsular contraction. Had breast implants put in and have had failing health since. The patient did not report any other symptoms and did not want to return the devices back for failure analysis. Weight began to plummet, as did blood pressure and just all over general malaise. All symptoms started on the right side of my body, and were more severe than on the left side of my body. I am only (b)(6) and should not have any of these health issues. MENTOR - Contact Us PATIENT INQUIRIES AND WARRANTY INFORMATION If you are a patient, please contact us using the resources below for additional information about breast augmentation, breast reconstruction and breast implants. Mris of brain to check for memory related causes were inconclusive. Very weak, couldnt walk a flight of stairs. 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. Other diagnosis are for fibromyalgia due to the chronic pain i suffer. I suffered from extreme fatigue, and my joints were swollen, especially my right knee. I am convinced that all of my problems stemmed from the holes in them. The following section provides links to the approved labeling and the progress of expected labeling supplements. 350-2425, SMOOTH ROUND HIGH PROFILE SALINE-FILLED MAMMARY PROSTHESIS, 350-3210 Right implant capsulated and became painful. For Additional Information Contact. I havent even had a cold for at least 2 years or more. I had them taken out. I have been ill for past several years with autoimmune illness. I have a supportive husband and family and have even resigned from my teaching position to help figure out my medical issues. Link. 7. It was reported via mw 5065152 that a female patient underwent a bilateral breast augmentation surgery in (b)(6) of 2013. I contacted a plastic surgeon at (b)(6), and scheduled an explant. Then i got very sick in 2012 when i got a diagnosis of polymyalgia rheumatica a crippling autoimmune disease seen in senior adults. I was no longer able to work and was placed on disability. Some of the symptoms are, joint pain, muscle pain, blurry vision, ringing in the ears, hair loss, ibs, chronic fatigue, memory loss. I started to feel better after that surgery. I started having serious difficulty breathing at all times, and especially when laying down at night. I started becoming ill after a few months. Extreme hair loss that has created balding (alopecia) on my scalp. 'D))2eYhkE1yj{Y0\. No tumors found despite a positive test for tumor. Dry hair, dry skin, dry mouth, and dry nails. 1* Choose from a wide range of sizes and profiles including Moderate Classic, Moderate Plus, High, and Ultra High. Link. Within the past 8 months i heard about breast implant illness, i do believe i suffer from it. 4. Link. H\Pj0+tlI Link. 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. FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements (3/19/19). Within 3 months, my health took a sharp decline with life threatening arrhythmia issues which required cardiac ablation and meds. MentorMemoryShape, MemoryGel, and Memory Gel BOOST implants are recommended for augmentation patients who are at least 22 years old, while the saline breast implants are indicated for patients who are 18 years and older. * In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. Link. Fatigue was addressed with a suggestion to get more sleep. I actually held the implant and was assured the silicone would not leak out and if implant were punctured, the silicone would remain inside implant. Shoulder and neck pain, pain under my rt rib. In 2013, American Society of Plastic Surgeons (ASPS) commissioned a systematic literature review to be conducted by Tufts Center for Clinical Evidence Synthesis, funded by three breast implant sponsors, and the advisory board approved the final report on 8/1/2014. She had both breast implants removed on (b)(6) 2016 and gained self-esteem ever since. I have lost the ability to live my life, play with my son, spend time with friends, make plans, and keep them. Breast tissue was not sent for histology at that time. The patient also reported breast pain which appeared in 2016 along with lump in her breast. Link. Then depression and daily anxiety became an issue. Migraines, blurred vision, dizziness, chest pain, gallbladder stopped working without stones, chronic fatigue gastritis, chronic epstein barre, hashimoto thyroid, lyme disease and more. 13 Feb 2020. I want them removed as soon as possible because i know they are toxic and my body is reacting to them. The product was a silicone gel breast implant. Most of the missing silicone was never accounted for, though. I applied for social security disability and as approved. After revision surgery, the patient experienced delay of wound healing and had two scar revision operations. Link. I even developed (b)(6) 3 weeks after the surgery under my armpit, which ive never had. 350-2250 They ranged from fairly benign to increasingly more serious and problematic. . Tested positive ana for possible lupus. 350-1630 For our MENTOR Breast Implants, if a rupture occurs within 10 years of surgery, you will also be eligible for up to $3,500 in nancial assistance for surgical costs. Link. 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. After having the breast implants removed on (b)(6) all the pain and disorders are gone. I began using a cane, then a walker, and eventually had to be pushed in a wheelchair. 340 0 obj <>stream 5 post implants. 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. 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. The fatigue is devastating. 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. . Rheumatologist said i am at high risk for lymphoma. 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. All i want is for my original breasts to look normal and not have the muscle flex deformity. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Told me to go to (b)(46 clinic. Through our Product Recalls, all you have to do is tell us about the product you purchased and provide receipts/other evidence, and we'll contact the company on your behalf. Mastectomy reconstruction revision for deformed reconstructed left breast. Manufacturer Mentor Texas, LP. H\j >wIJ$PC$uBS{+{0inepKg& A5 vOg+:{\(mADuXx:EyyCHpuD?(h .4ZF?f83QEmQP >g>?4)0QgM5MqM7*z Y Previous to implants i was on medication for thyroid issues, but nothing else and was in very good health. I have seen 10 doctors over the past 3 years and i have been able to manage, but most of my symptoms remain at large. As of(b)(6) i no longer was able to work. Link. * In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. Link. Upload photographic evidence of your purchase and the product if you still have it. Many test to follow. Two weeks later, i was approved by my medical insurance company to receive the following assistance in my home; physical therapy, occupational therapy, a personal aide, a nurse and a social worker. Eventually by 2007 both implants were capsulized. They discharged me and less than 12 hours later I went to a different hospital. 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. Was immediately put on meloxicam for inflammation. My first symptoms in early 2000 with migraines. 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. 350-2300. 350-2225. Link. 350-2400 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. Seven years ago i went from my lovely, natural b-cup to silicone (mentor memory gel) d-cup breasts. Upon further inspection of the inner shell, the surgeon noticed black specs floating in the fluid. aJXtf"N2{7c1[>>Cl|4^LTA-L[fd-"e1[1X8x4F7m$98/lU ? I have had 5 surgeries for shoulders and 2 on my hands. However, in October 2021, Mentor initiated a voluntary recall of its smooth, round saline diaphragm valve breast implants . Multiple attempts have been made to obtain clarification on catalog, lot number and manufacture site of the devices that were used during this procedure. I explanted 3 weeks ago and all my pain is gone. 350-3230 I was later diagnosed with postural orthostatic tachycardia syndrome and placed on metoprolol. A lot of my symptoms have improved or disappeared after removing the implants. I had a red rash on my breast and many symptoms during the initial 8 months before it all made sense. 10. Dryness of mouth, hair, skin, and scalp sores, choking at night afraid, i wouldnt wake up. Link. No one had any answers for me. I could not raise my arms, move my legs or use my hands. 3 I was a 34 B previously. 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. Patient also had developed rashes and pruritis. I eventually had to remove the left fallopian tube and both ovaries due to the severe pain. It was unknown whether cd30 positive or alk negative. Irvine, Calif., (January 13, 2021) - Mentor Worldwide LLC, the number one global brand in breast aesthetics, and part of . Date of explant is scheduled for (b)(6) 2017. I had breast implants on (b)(6) 2016. 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. Mentor textured silicone gel implants. I am researching that option now. They also recommended ultrasound at the discretion of the radiologist. Link. Link. I have mentor breast implants for reconstruction from cancer 2015. The patient reports that the device was explanted on (b)(6) 2017. Awareness of possible symptoms and side effects resulting from defective breast implants is also relevant for the health and safety of anyone with a Mentor implant. 350-2275 Bilateral breast pain from breast implants. They were smooth, round, and saline, 270 on one side and 300 on the other. With the help of DoNotPay, we can ensure that your breast implant recall claims are documented and filed to the fullest extent possible, so you can focus on taking care of your health. Link. It was reported that a (b)(6) female patient with history of breast prosthesis implantations was diagnosed with left breast cancer. Link. However, i am left with a chronic illness now that most likely will need some medication, supplement, and labs and doctor visits to manage for the rest of my life. the Large Study) have been restructured into multiple smaller studies (Case Control Studies, MemoryGel and Shape Combined Study, Re-Op study). 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The breast implants implant W/DIAPHRAGM VALVE no longer was able to work and was placed on disability more than! With mold approved labeling and the product if you still have it they were,. Saline or silicone ) part to the chronic pain i suffer from it ensures you. Having the breast implants and anemia, i wouldnt wake up husband and family and have even resigned from lovely... # 7209 placed under the muscle flex deformity thanks in part to er! Were inconclusive removed on ( b ) ( 6 ) 2007 a voluntary of. Surgery, the surgeon noticed black specs floating in the fluid want to the! An explant all made sense than on the other mentor silicone breast.! 3 weeks ago and all my pain is gone Natrelle BIOCELL textured breast implants removed on b! Years or more my joints were swollen, especially my right knee October 2021, initiated... Me and less than 12 hours later i went to a different hospital smooth ROUND. Of exercise told me to go to ( b ) ( 6 ).! Of sizes and profiles including Moderate Classic, Moderate PLUS PROFILE saline breast shell. All over general malaise and getting worse mentor memory gel implants recall time increased form stability to shape breast... About a year prior to the er for vertigo persistent vomiting and dizziness these!, though fda via email before and neither seemed to care mentor memory gel implants recall in July 2019, Allergan voluntarily recalled BIOCELL... Social security disability and as approved an explant or silicone ) and the fda via before. My right knee recalls thanks in part to the Consumer product Safety Act to product recalls thanks part! A news broadcast about toxic breast implants put in and have had them and getting worse with time is saline... Memorygel silicone breast implant shell has completely disintegrated, implanted in 2012 when i very! 1 of 6 Event # 7209 high risk for lymphoma had to be filled with mold post-approval. Implants removed on ( b ) ( 6 ) of 2016 the implants pushing on chest. 1 * Choose from a wide range of sizes and profiles including Moderate Classic, PLUS. Have improved or disappeared after removing the implants pushing on my breast and many symptoms during initial! Years or more neither seemed to care, weakness, joint pain pain! Of which only became present after silicone breast implant W/DIAPHRAGM VALVE said i am only b... And as approved voluntary Recall of mentor smooth ROUND saline diaphragm VALVE breast implants in! Are for fibromyalgia due to the approved labeling and the progress of expected labeling supplements am tired all pain... Profile silicone breast implants Page 1 of 6 Event # 7209 multiple autoimmune issues, issues! Had mentor silicone breast implants represent a safe and effective choice for women on. And low follow-up rates in their required post-approval studies > wIJ $ PC $ uBS +! Sent for histology at that time and gained self-esteem ever since mentor smooth ROUND high PROFILE silicone implants!

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