Over the past 3 years i have slowly begun to improve. Weekly b12 injections. Read Mentor's full statement below: "Nothing is more important to Mentor than the health and safety of the . The plastic surgeon at (b)(6), removed the implant material by opening up what was left of the capsules rather than using the en bloc method, which is now standard. k-9(J((5*k?aT/SZ D z:Trx%(o8L?h{C5t*Q Have various test. 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 even developed (b)(6) 3 weeks after the surgery under my armpit, which ive never had. Mri report ((b)(6) 2017) cites patient had augmentation revision procedure in 2008 (no further information stated; no information on types or brand of implants used). I was diagnosed with alcl in 2016. Due to length of initial surgery as well as length of hospitalization, i chose to wait. Extreme vitamin d deficiency. Extreme chronic fatigue, atypical connective tissue disease, breathing problems laying down. 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. I was shocked as nothing like this was ever heard of in my family. 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. Link. I have 3 children and im extremely scared that im going to die from this illness. Mentor Memory Gel Implants. 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. Lowered immune system, and i get sick (strep throat, colds) and i never used to, slow clearing of colds. Link. The shell is filled with MemoryGel , Mentor's proprietary formulation of medical grade silicone gel, and is constructed of successive cross-linked layers of silicone elastomer. April 2013. Over the next 3 years my health steadily declined with unexplained symptoms. As soon as 4 months after implantation i had an emergent visit to the er for vertigo persistent vomiting and dizziness. I had silicone breast implants from mentor in 2013. Core Study:The follow-up rate was 62% at 10 years. Link. No one had any answers for me. SALINE-FILLED MAMMARY PROSTHESES WITH DIAPHRAGM VALVE. They also recommended ultrasound at the discretion of the radiologist. 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. I started having sensitivity to foods which i never had before and the foods cause pvcs. (Unknown if it is Mentor saline or silicone). Please help me before i lose my life. Burning red rash on my eyelids. 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. Case-Control Study:Terminated. 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. Link. !C`2D0NzI%jFCBZZ#XJA|r Y^kb?3q4 MENTOR Warranty I was in extreme pain, and i began losing my hair. Follow instructions in the letter and immediately return any inventory of MENTOR Smooth Round Saline DV Breast Implants with expiration dates ranging from 01/01/2025 to 09/30/2025 subject to this recall to Sedgwick. Dry eyes, blurred vision, double vision, and eye pressure. I have state insurance as of 2012 after being too ill to work full time and my dr does not accept this insurance. Link. Gi issues, pain. Link. 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. This is five years of my life i cant get back. This is socially unacceptable because i have to cough and spit all the time trying to get this extremely sticky substance out of my throat. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Risks and Complications of Breast Implants, Medical Device Reports for Systemic Symptoms in Women with Breast Implants, Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma, Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), Things to Consider Before Getting Breast Implants, Breast Implant Postmarket Safety Information, FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants, Breast Implants - Certain Labeling Recommendations to Improve Patient Communication, Saline, Silicone Gel, and Alternative Breast Implants guidance, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders. More research needs to be done and patients need to be warned of other medical harm that can happen because of the silicone implants. From 2014-2015, some studies (e.g. 14. I struggle everyday to do things and plan to explant soon. There are 20,000 of us there with the same stories. Link. i have been so sick i feel like i have to try getting them out to see if i have a chance to get some sort of my life back. Team of doctors at (b)(6) clinic couldnt figure out what was happening to me. The patient believes that the discoloration is a fungus growth inside the right device. UT]b$c} There was no patient contact reported. Difficulty sleeping, difficulty recalling words (mixing up words), short term memory issues. Recent study shows patients and surgeons both preferred the MENTOR MemoryGel BOOST Breast Implant as feeling more like a natural breast versus another leading brand. I went from saline smooth implants to textured cohesive gel implants. Breast implant manufacturers may need to update product labeling as the FDA learns new clinical information. hb```l@(0>.JO;%.mP'cGGE[GCKGGG>aS4FeX#aD{9L'0baZ\C@Ib @w?Vf . Physician did not perform any pathology tests. When recalls are as vital as a Mentor breast implant serial number recall, you should never ignore them. Health product - Medical device - General and plastic surgery. The procedure was completed with different device. Link. 350-3460. i no longer had shortness of breath. Swollen hands, tingling in the hands and arms when i bend my joints. q@8mhD";BN"z\h[-1k90p UpK&uEO`W4]76 $gQsB#ZYWG[1!EMd[O'teY3c[UhgE?_u `6 MemoryGel Breast Implants provide a soft, natural feel desired by patients. There may also be a variety of associated costs. She had breast asymmetry on the right side. Since this event involves device sterility and could have led to an adverse event or serious injury, it is considered serious and mdr reportable. 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. Apparently mentor did not get the message about a ban on implants. A sponsors failure to comply with any post-approval requirement may be grounds for withdrawing approval. FDA. Link. Immediately following the implantation, i began having two periods per month, which was not something i ever had before. Pathology and currently waiting to explant. The patient reported to have several undisclosed illnesses within months of getting the implants put in. The implant was removed from the field and a new implant was used for the procedure. PMAs with Product Code = FTR and Original Applicant = MENTOR CORP. I dont even know how to put it in words. So i am reporting my situation. I had a 3-d mammogram and everything looked fine. Device description with a list of specific materials in the device. I have called the surgeon that performed the surgery to get in for check up. Mentor Worldwide Historical Implant Data 1985 May 2018. 3 Mastitis, cellulitis of the breast. I am so sick I cant function !!! Multiple attempts have been made to obtain more event details, however, no additional information has been made available. Smooth surfaced implants are not affected by this recall. Link. MENTOR Smooth Round Saline DV Breast Implants (Lot Numbers with Expiration Dates from January 01, 2025 to September 30, 2025) Instructions for Downloading Viewers and Players. I have been unable to return to the job that i loved. This somewhat lessened some of my symptoms but i still felt sick like i was dying slowly. Link. Auto immune disease, hands were swollen, red, and itchy. (1/5/17). I was able to have a visiting nun come once a week also. I had smooth mentor memorygel breast implants placed under the muscle 2. Right implant capsulated and became painful. 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. Link. Unknown if it is Mentor saline or silicone: Mastitis, swelling, nodules and varius other illness. I got severe spinning vertigo that lasted 6 years. 3 1. Mri confirmed that bilateral implants were ruptured. Post-approval studies (PAS) are conditions of device approval. Surgery lasted longer than expected due to the difficulty of removing the silicone. The changes i have had in my body in the past 15 months have been so drastic for me. I have chronic widespread pain and digestive trouble. On (b)(6) 2016 she underwent revision operation due to breast implant leak. Patient presented with bilateral implant rupture. The FDA issued final guidance, Breast Implants - Certain Labeling Recommendations to Improve Patient Communication in September 2020. I know many, many(over (b)(6)) women suffering with this same situation. The patient also reported breast pain which appeared in 2016 along with lump in her breast. Also, gel fracture is a new phenomenon that has been identified for . Any ideas what this is? Have had blood tests where discovered i had thyroid issues and then found out i had hashimoto. We have helped over 300,000 people with their problems. FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements (3/19/19). 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. Device Tracking Form supplied by Mentor with each silicone gel-filled breast implant. 350-2250. Mentor Silicone Gel-Filled Breast Implants are devices with shells constructed from silicone elastomer. My last hope was to check these out via breast mri. that patients can be contacted in the event of a recall or other problems with the implants that they should be made aware of. 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. I went to the er, where they werent sure what was wrong and gave me antibiotics, which had no effect. Memory problems, disturbing enough to affect me emotionally as well. In 2019 I started experiencing severe lower abdominal pain that sent me to the emergency room several times. * In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. It has been a year of feeling acutely ill. Then in 2011, i was diagnosed with a rare blood cancer. Dry eyes (difficulty crying) dry mouth (always thirsty) dry throat (difficulty swallowing pills, food gets stuck) gel hoarse, especially in evenings. She was diagnosed with rheumatoid arthritis one year later. Developed anxiety and uncontrolled vaso-vagal responses. Link. Each implant is filled with Mentor's cohesive gel, which holds together uniformly and retains a natural give that better resembles breast tissue. C reactive protein is measuring 48 or higher. Skin rashes only getting worse and slight fibromyalgia diagnosed by dr. (b)(6). I know it was the implants pushing on my chest, probably due to the capsular contraction. Updated silicone gel-filled breast implant rupture screening recommendations. Additional mammograms were done on (b)(6) 2016 and (b)(6) 2017. On the date listed above, i received breast augmentation with mentor smooth round high profile gel (silicone) implanted ref (b)(4), left lot #6528127, sn # (b)(4) and right lot #5950089, sn # (b)(4). Have heavy metal toxicity and silicone has been found in my lymphnodes of my left armpit and chest wall. Link. Menstrual period only twice or so a year (started in 2008 after implants). After doing research on my own and some common sense. I have been ill since having silicone implants fibromyalgia, sleep disorder, pain in neck, shoulders, hips, legs, feet, and back. No reports of rupture or other product issues. Link. The surgeon noticed a piece of plastic that was attached to the outside of the shell. This implants are taking my life away . I got mentor implants. I was systemic. Link. Less than 6 months after having these implants, i started to develop multiple symptoms. Link. i was confronted with a whole host of issues- developed hypothyroidism, adrenal fatigue, hormonal imbalance, irregular periods, candida, 15lb weight gain, fatigue, constant pain in my chest (especially on the rt side), all over muscle soreness, joint pain, hair loss, hair texture changes, strange rashes, heavy legs and swelling, low body temperature, skin elasticity changes, cellulite, muscle loss, brain fog, more food allergies, ibs, and a few vitamin deficiencies. She was scheduled to remove implants the following month. Then i got very sick in 2012 when i got a diagnosis of polymyalgia rheumatica a crippling autoimmune disease seen in senior adults. 1-800-MENTOR8 (800-636-8678) Monday - Friday, 5:30 a.m. - 5:00 p.m. PST, excluding select holidays The health consequences of a ruptured silicone gel breast implant have not been fully established. 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). Cognition problems, neurological issues. 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. Dizziness muscle cramping, bone pain, myofascial pain, gastrointestinal/abdominal pain, inability to exercise despite being a lifelong competitive athlete. 350-2275 Redness all over my body. Link. Link. endstream endobj startxref Smooth mpp gel mammary prosthesis. 'D))2eYhkE1yj{Y0\. In 2012 the plastic surgeon, dr (b)(6) of (b)(6) told me that this new silicone was perfectly safe, wont travel to other parts of your body if it ruptures, and had at least a 10 year lifespan. Worsened over a period of 5-7 years post implant. 5 years, she began to suffer from serious health issues, including but not limited to, constant headaches, difficulty with concentration and focusing, constant pain and swelling in left breast, high anxiety, shoulder and neck pain, obsessive compulsive disorder, muscle weakness, symptoms that resembled fibromyalgia, insomnia, memory issues and other symptoms resembling chronic fatigue syndrome. 10Year Core Gel Final Clinical Study Report. This generally occurs at the end of the ten-year post approval follow-up period for patients that received the implant during investigational studies and when new post-approval studies are completed. **1 y* Over time since implants. I have constant infections. Link. 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