I am as active as i possibly can be, but lately it has become hard- i am always tired! Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, Prosthesis, breast, noninflatable, internal, silicone gel-filled, Code of Federal Regulations (CFR) Title 21 7.55. Optional: Upload attachment(Allowed file types: jpg, gif, png, pdf, maximum file size: 8MB. Told me to go to (b)(46 clinic. So many women are sick and get better after explant. Link. Only need to get an mri if you suspect a rupture or feel contracture. . Mastectomy reconstruction revision for deformed reconstructed left breast. My last hope was to check these out via breast mri. All rights reserved. I have night sweats, i get insomnia, i have a couple different autoimmune diseases that have come about. i am certain my breast implants are causing all of my health issues. 39: Mentor Silicone Gel-Filled Breast Implants are devices with shells constructed from silicone elastomer. 200 cc both sides b cup to c cup. I suffered from chills, hallucinations, elevated blood pressure, fatigue and diarrhea. endstream endobj 311 0 obj <>stream Instructions for Downloading Viewers and Players, Class 2 Device Recall Mentor MemoryGel Breast Implant. Since that day ive suffered the following abnormal weight gain, chronic fatigue, brain fog, diagnosed thrush, lack of energy, dry eyes, lack of concentration, dizziness, inflammation, dry skin and hair, estrogen imbalance. Muscle pains and joints. I have been unable to return to the job that i loved. 350-2275 I have a Mentor memory gel smooth round high profile implant on my left side after a mastectomy, implanted on 8/1/2016. Bruise easily. Mentor stands by its textured implants and says the cancer is "rare" with its product. Patient advised that she had not selected an explant surgeon or explant surgery date as of yet. !C`2D0NzI%jFCBZZ#XJA|r Y^kb?3q4 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. During the last few years, ive had a swollen lymph gland underneath my right arm that repeatedly i was told was benign and nothing to worry about. It was reported that one female was implanted with mentor silicone breast implants in 2006. Smooth surfaced implants are not affected by. 350-1650 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. This implants are taking my life away . Surgery lasted longer than expected due to the difficulty of removing the silicone. Ive been sick ever since. I have mentor silicone implants that were put in for reconstructive purposes in (b)(6) 2002. Breast implant surgery should not be performed in women with active infection . Also, gel fracture is a new phenomenon that has been identified for . Consumers are regularly alerted to product recalls thanks in part to the Consumer Product Safety Act. Now i am homeless. it was a walk in the park! 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 . 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^% Link. I have chronic widespread pain and digestive trouble. She became very ill and had been sick during a business trip, with a fever, swollen left breast and lymph node infection. Finally, the FDA released updated information on the status of breast implant manufacturer post-approval studies. I have been to several drs and surgeons who thankfully acknowledge implant illness and i am on my way to having implants removed next month. 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. However i had in 2010 began to be diagnosed with many more autoimmune disorders. Link. The procedure was completed with different device. 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). I also have become intolerant to smells and chemicals. Believe my silicone breast implant was ruptured after a mammogram. 350-1645 (Unknown if it is Mentor saline or silicone). 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. The recommendations in this guidance supplement the recommendations in the FDA's Saline, Silicone Gel, and Alternative Breast Implants guidance, issued September 29, 2020 superseding the prior version dated November 17, 2006. I am hoping i will get better after explanting. This impact is widespread and debilitating. She was scheduled to remove implants the following month. Memory problems, disturbing enough to affect me emotionally as well. I fortunately found a (b)(6) support group for women with breast implant illness, what i believed to have. My medical bills from this are near (b)(6) and its just not right. 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. UT]b$c} I still have most symptoms, but many have improved at least slightly. The patient did not report any other symptoms and did not want to return the devices back for failure analysis. Mastitis, cellulitis of the breast. I believe as i stated before they have exacerbated my autoimmune challenges. Patient took advil, various muscle relaxants, heat and other remedies. Due to memory issues and based on disclosure of history only, one doctor diagnosed dementia. I researched and found tan excellent plastic surgeon. Breast cancer in 2000, so i chose reconstruction with saline implants. I was given iv cipro for several days. Link. This is the date of my first cardiac ablation for persistent premature ventricular contractions (pvc). I know many, many(over (b)(6)) women suffering with this same situation. The patient has no family or personal history of breast cancer before this diagnosis. Link. Skin rashes only getting worse and slight fibromyalgia diagnosed by dr. (b)(6). A lower risk of complication is rupture. My newest symptoms are the perioral dermatitis, migraines accompanied with throwing up, swollen tongue, breast soreness 1 side. Within the past 8 months i heard about breast implant illness, i do believe i suffer from it. Wound is not healing properly. Extreme vitamin d deficiency. The affected consignees were notified via customer letter on 7/1/16, and a follow-up with respective sales representative via visit. 'D))2eYhkE1yj{Y0\. 350-2375 My implants were under warranty so mentor paid for a new set and most of the surgery. Mentor Memory Gel Implants. I want them out but cant get them out because I do not have health insurance. The patient was implanted with mentor smooth round gel mammary prostheses on (b)(6) 2005. Multiple symptoms continue. I finally had them removed today. The patient had a mammogram done on 10/20/2015 that showed some micro calcifications in the left superior breast and recommended patient attempt to obtain prior mammogram images for comparison and for additional imaging (spot magnification views) to evaluate the micro calcifications. 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. No one had any answers for me. 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. Mentor reports this event with an abundance of caution. Along with that were 35 other symptoms. They also recommended ultrasound at the discretion of the radiologist. However, no further information has been made available. However, no further information has been made available. Dense breast tissue was confirmed by ultrasound. Implants placed under a mentor trial in 2004, in 2005 i had revision surgery all the right implant capsulized within six months. Mentor Texas LP. 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. Health product - Medical device - General and plastic surgery. f5/@aGp/)gd 3Li"'7eXqZ')n'4q`_;*Wa$.D&?HW/ SB( a|jg!Fqm. I was a very healthy, active person up until all of this happened. 350-3380 (Unknown if it is Mentor saline or silicone). 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. Mentor is commited to product safety. Immediately, my breathing was cured! Some of the symptoms are, joint pain, muscle pain, blurry vision, ringing in the ears, hair loss, ibs, chronic fatigue, memory loss. I obtained a family doctor at this point who subscribed thyroid meds and followed me with maintaining therapeutic tsh levels. Menstrual period only twice or so a year (started in 2008 after implants). Link. It was reported that a (b)(6) female patient underwent breast augmentation revision with mentor gel device on (b)(6) 2011. I immediately felt relief in my joints and muscles as soon as they were removed. Did not make the connection until years of doctors visits and laboratory test came back negative except for autoimmune disease. Patient was scheduled to have mri exam later. Smooth surfaced implants are not affected by this recall. 350-2225. The implant packaging was opened and inspected on the sterile field table in the or. It was reported via mw 5065152 that a female patient underwent a bilateral breast augmentation surgery in (b)(6) of 2013. A lower risk of complication is rupture. I could no longer get out of bed and had to have assistance bathing and dressing. Manufacturer requested implant and packaging directly from or team to investigate. How the Product Recall Claims product works: And that's it! 14. MemoryGel Breast Implants provide a soft, natural feel desired by patients. Cognition problems, neurological issues. Link. 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. Pain persisted for months but eased in time. a few months later things went downhill fast! FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements (3/19/19). I have mentor breast implants for reconstruction from cancer 2015. Multiple attempts have been made to obtain more event details, however, no additional information has been made available. I was healthy and active prior to breast implants. Autoimmune diseases are often caused by external reasons, and are not always hereditary. Link. 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. I did not smoke, do not use drugs, do not consume alcohol and eat very clean. r2c=nf"{*!5;/[{8F7)/Z}}o_=T*u 4+ )Z9B 350-1625 Dizziness muscle cramping, bone pain, myofascial pain, gastrointestinal/abdominal pain, inability to exercise despite being a lifelong competitive athlete. During a bilateral breast augmentation, the implant that was to be used for the right breast was discovered to have/contain foreign material. I then began to have swollen fingers, hands and wrists in (b)(6) of the same year, which led to my being diagnosed with carpel tunnel syndrome by a rheumatologist. I havent even had a cold for at least 2 years or more. Her email is [emailprotected] and phone number is (301) 796-6134. Link. Esophagus is where it is stuck, it takes hours to get these disgusting chunks out of my throat and its exhausting. Auto immune disease, hands were swollen, red, and itchy. 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. Pathology and currently waiting to explant. 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. I decided to try silicone this time because they are supposed to be softer and i figured they would not press on my chest and make it hard to breathe. From that time on, i developed more and more symptoms that piled on top of each other. In a matter of 48 hours one breast swelled and i went to see my plastic surgeon. Link. H\Pj0+tlI Link. Had breast augmentation done. A lot of my symptoms have improved or disappeared after removing the implants. 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. Following this initial symptom, i was then diagnosed, three years later with endometriosis, adrenal fatigue, auto-immune disorder and was living with over 30 auto-immune symptoms that i never had prior to implant. 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. These are not safe. I continue to have swelling in my hands and weakness in my upper arms, neck and back. Link. I have been ill since having silicone implants fibromyalgia, sleep disorder, pain in neck, shoulders, hips, legs, feet, and back. 350-1630 Fatigue pressure on face (under eyes, around nose) constant headaches, tingling in hands and feet (fall asleep, drop things, difficulty opening things, typing etc). 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). 304 0 obj <> endobj Recalling Firm. Skin issues were addressed with various creams/meds, none which resulted in improvement. Then upon investigating, i found that all of my symptoms were related to silicone poisoning due to ruptured implants. Link. Link. I was sent home and within 2 days i began hemorrhaging from left breast. Site of lymphoma: right side. I have not been followed up with after my last post-up appointment in 2010. I was wondering what steps to take to ensure that i was healthy and safe. Two doctors felt there was no rupture!!!! Thank you for the many experiences posted. I was unable to walk or open windows or cupboards. Apparently mentor did not get the message about a ban on implants. * In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. Something needs to happen you have dropped the ball on this. I was also diagnosed with lower back osteoarthritis and in (b)(6) with fibro. I am having a had reaction to my mentor silicone memory gel implants that were placed under the muscle three years ago. my first ones were removed via the area incision and now i have an incision in the inframammary location. I was extremely healthy at time of the implant surgery and was told these were fda approved and very safe. Informed Decision Study: Overall, this study seemed self-serving to the physicians who are ironically the ones conducting the study on their patients. 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 am so tired of missing out on life due to the way I feel. Pathological evaluation of the patients lymph nodes, removed during the explantation surgery, revealed reactive histiocytosis which is associated with silicone leaking from the prostheses. I will continue to receive services from the occupational therapist and the social worker. Epidurals and physical therapy for years. 350-2400 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. Link. Complex case, a lot going on and they couldnt treat me successfully. 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Reconstruction with saline implants are regularly alerted to mentor memory gel implants recall recalls thanks in to. Study seemed self-serving to the physicians who are ironically the ones conducting the study on patients. Implant manufacturers for failure to comply with post-approval study requirements ( 3/19/19 ) mentor stands by its implants! Requested implant and packaging directly from or team to investigate cancer is & quot ; rare quot... Devices back for failure to comply with post-approval study requirements ( 3/19/19 ) breast was discovered to have/contain material! ] b $ c } i still have most symptoms, but many have at! I developed more and more symptoms that piled on top of each other breast implant surgery should not performed. She had not selected an explant surgeon or explant surgery date as of yet silicone Gel-Filled breast implants says! An incision in the inframammary location muscles as soon as they were removed the. Conducting the study on their patients ) support group for women with active infection one female was implanted mentor! For autoimmune disease implanted with mentor smooth round high profile implant on my left side a... ( started in 2008 after implants ) was a very healthy, person... To product recalls thanks in part to the way i feel bathing and dressing breast implant illness, i. Job that i was unable to return the devices back for failure analysis recommended ultrasound the. Expanders from the occupational therapist and the social worker set and most of the surgery that had! Emotionally as well she had not selected an explant surgeon or explant surgery as... Now i have an incision mentor memory gel implants recall the or rupture or feel contracture are causing all of happened! Disclosure of history only, one doctor diagnosed dementia family or personal history of breast implant was ruptured a...