9556175 MENTOR Smooth Round Saline DV Implant 350-1615/00081317001188 This didnt add much time to the procedure. Its clear that the silicone toxins released through the shells were attacking my autoimmune system. 9572394 3502425/81317001447 The patient was treated with chemotherapy and radiation therapy. Approx 6 months after having breast implants, i was diagnosed with hashimotos thyroid disease, which is auto-immune. 9536098 This cancer occurs more commonly in patients with textured breast implants than smooth Implants, although rates are not well defined. capsule had gone away? 9557442 Premature aging, vision disturbances, digestive issues. Link. 9528580 Blood tests for sjogrens disease, came back negative, due to my dry mouth. Instructions for Downloading Viewers and Players. It stated that the implant did come in contact with patient. 3501695/81317001324 9582183 This past year developed severe eczema on both nipples and surrounding tissue. 3501620/81317001195 9561194 Within 6 months i developed autoimmune disorder; candida cystic acne, unexplained weight gain, cold sores, toe nail fungus, brain fog. Glad to see Im not alone, Mentor implants in for 19 years everything Ive read here seems like a clip from my own life, so many issues, been dealing with one issue after another for at least 8 years, removal consult in 2 weeks, I have had mine in for 20 years. Its three weeks post-explant and im down 7 pounds with a completely sedentary existence while recovering from surgery. Youll have up to two weeks of downtime while you heal. I am concerned i will not get the proper treatment to get well. 800-235-5731. Link. I had a saline breast implant rupture (b)(6). 9535778 Other problems have been, brain fog, sad, allergies consistently, heavy periods at age (b)(6) and had to have cryoablation, cystic breasts with one biopsy (neg) and several aspirations of cysts, and finally the most recent, feeling of helplessness because of all my aching joints. 9553668 I want them removed as soon as possible because i know they are toxic and my body is reacting to them. Today, the U.S. Food and Drug Administration issued warning letters to two breast implant manufacturers for failure to comply with their requirements, under their premarket approval orders, to conduct post-approval studies to assess the long-term safety and risks of their silicone gel-filled breast implants. I want to get the implants taken out, but cant afford to do so. During routine set up, the physician found that the package of the implant did not contain the dome pack accessory. Safety data such as reoperations, deflation, capsular contracture, and pain will be collected annually out to 10 years for each patient. 9525967 I was not told of any potential harm and conversely, the original doctor told me that women complaining of issues after implants were not related to the implants. I was depressed, no one knew what was wrong. 9535132 9561861 They lie and dismiss my issues. 9553108 He has put me on diflucan for 5 weeks and requested my rheumatologist refer me to an infectious disease doctor. I know it was the implants pushing on my chest, probably due to the capsular contraction. Or have experience with a medical device? Lot Numbers: 9588332 I think my immune system started deteriorating in 2010, however, being so physically fit, the symptoms were masked until 2013. 9599498 Anxiety, depression, and panic attacks, pain and/or burning sensation around implant and/or underarm, cold and discolored limbs, hands and feet, general chest discomfort. 9586783 Link. Issuing Office: Center for Devices and . Any non-affected product and any product returned after the dat. 9582572 The restrictions on sale and distribution are included in the Post-Market Approval (PMA) Supplement Approval letter for these implants. The FDA remains committed to thoughtful, scientific, transparent, public dialogue concerning breast implant safety and effectiveness. 9570169 9534032 Your complete guide to recalls, "breast implant illness," and the conversation surrounding them. Scroll down for a list of symptoms women have reported to the FDA and for reports of mold, manufacturer issues, BIA-ALCL, other cancers, body parts removed, and pre and post approval study follow-up. Link. Link. Frequent urination, numbness/tingling sensations in upper and lower limbs, cold and discolored limbs, hands and feet, general chest discomfort, shortness of breath, pain and/or burning sensation around implant and/or underarm, liver and kidney dysfunction, cramping, toxic shock symptoms, anxiety, depression and panic attacks, leaky gut, ibs and sibo symptoms of or diagnosis of fibromyalgia, symptoms of or diagnosis of lyme disease, symptoms of or diagnosis of auto-immune diseases such as; raynauds syndrome. 9578063 I believe the reason for all of my autoimmune diseases are a direct result of breast implants, recall all. I had an mri conducted with and without contrast and saw an ms specialist who was not concerned that i had ms. What is your recommendation? 9562723 9541226 9576451 The implants were 5 y/o when my son was born. Joint aches = reduced by 50 percent at three weeks post-op. 9611964 He sent me on a chase for medical records 23 years old. July 30, 2019 Answer: Implant recall and breast implant removal The recall of Allergan Biocell textured implants applies to implants that are on the shelf. Same here. I was diagnosed with acute thyroiditis. In (b)(6) 2014, i had a 2 week occurrence of vertigo. 9620460 9549491 9590028 9564913 I have chronic joint pain, fatigue, anxiety, migraines, hair loss, and many other issues. 9550163 My hormones are completely of whack. There is not a recommendation that women who have had these implants placed explant them. On monday (b)(6) 2017, i went to (b)(6). 9608405 9594634 9586122 This is real!!!! 9532946 9608403 9617818 not to mention the numerous times i have attempted suicide. I had my explant bilateral capsulectomy 01-14-2020 and am grateful to #1 GOD and secondly to all the medical community including my dentist that recommended a TMJ Pain Specialist who made me realize I was taking way too many prescriptions over a decade and some were opiates. In 2015, doctor found lump in right breast, mano shows calcification on left, right has 2 cyst at 10 oclock, had biopsy ductal plasia on right breast, had breast mri last week. July 29, 2019. Link. 3503310/81317001638 9616495 I want my breast implants out, as i feel that i may get my life back. Up to 1000, financial assistance to cover part of your surgical expenses should your implant rupture. Link. Hence, follow ups for further investigation could not be performed. The mentor spectrum saline implants were the devices implanted at the time of diagnosis. I have debilitating days. Link. Lot Numbers: I love my breasts but I have SO MANY of the symptoms listed here. 9574053 Explanted (b)(6). I also tested positive for lyme disease. 9594633 Ive had symptoms of depression, anxiety, fatigue, hair loss, back and neck pain, pain in my breast, joint pain, numbness in my hands and arms, swallowing problems with chocking, unk rashes, and hormone imbalance caused hysterectomy (b)(6) 2016. I became very ill, diagnosed with fibromyalgia, capsular contra (grade 3 and 4) many symptoms to include; chronic body pain, breast pain, chronic fatigue, hair loss, muscle, joint weakness and pain, ringing in ears, ibs, insomnia, anxiety, depression, tingling and pins and needles in hands and feet, headaches, weight gain, food intolerances, shoulder, neck, back, arms, hands, leg and foot pain, heart palpitations, shortness of breath, inflammation, diagnosed with fibromyalgia and arthritis, breast tumors and cysts. 9550674 Rashes = gone. All symptoms continued to worsen until surgical removal with total encapsulectomy bilaterally in (b)(6) of 2017. I have extremely low libido, shortness of breath, skin rashes, insomnia, hormone imbalance, tingling and/or numbness in the arms and legs. Since your post was 2020 did you get your explant? 9550485 I got mentor saline breast implants and right after stated having symptoms resembling ms joint pain, confusion, numbness, brain fog, hormone issues resulting in hysterectomy at (b)(6). 9530727 9587327 9552231 Allergies to adhesive-localized thyroid issues cannot regulate it and i never had this problem before. Didnt feel as strong at the gym wrote it off as low iron. Link. On 1998 experienced cfs, brain fog and was disabled. The patient underwent explantation procedure on (b)(6) 2016. I am two weeks out from surgery and i am healing every day. My ana was positive right before explant (b)(6)2017. 9606469 We expect these manufacturers to meet the pre-specified study requirements in order to ensure the collection of long-term data that can be used to inform long-term patient safety. Mentor Saline-Filled Breast Implants - FDA Information Scroll down for a list of symptoms women have reported to the FDA and for reports of mold, manufacturer issues, BIA-ALCL, other cancers, body parts removed, and pre and post approval study follow-up. Especially the last year. Lot Numbers: 3501650/81317001256 9570471 IMPORTANT SAFETY INFORMATION: See reference section below for a Black Box Warning for breast implants and important safety information. God Bless everyone, its nice to know Im not crazy! 9580874 I have felt as if i was dying. On 10/11/2021, the Firm sent an "URGENT MEDICAL DEVICE RECALL (REMOVAL)" Notfication via UPS informing customers that breast implants which have expiration dates from 01/01/2025 to 09/30/2021, due to a manufacturing issue may have a potentially weakened area on the base patch portion of the shell. 9596801 9539276 Over the course of the next year i also suffered from anxiety, hair loss, dry skin, rashes, acne, tight chest and trouble breathing, rib pain, brain fog, memory loss, headaches, temperature intolerance and the list goes on; 29 total symptoms in all. After having a double mastectomy for stage one breast cancer, I was suppose to have smooth silicone implants put in. Sadly, I was not informed that if some of us have pre-existing conditions, it could lead to permanent disability due to chronic pain and constant inflammation with a plethora of conditions that makes ones life difficult to live on. 3502650/81317001508 Please help make the mfr put a warning, so ladies will know what they may be dealing with in the future due to breast implant illness. Mentor and their irb did not do any f/u with me although i worked on the same street as mentor and i did further charity work with the surgeon through my companies devices we donated. Up to $3,500 for capsular contracture (Baker grade III/IV), double capsule , and late seroma complications for 10 years. I became bedridden and only made attempts to get up to see another doctor to just get no answers to my sudden health decline that felt like i was dying some days. He has health issues that are related to the toxic exposure while in womb of the leaking implants. If additional information is received, a supplemental 3500a report will be submitted. 9597740 9617820 9587065 I used to wake up every day in pain, and contemplating suicide many times because i thought i was going to have to live like that the rest of my life. 9553670 Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. All these things are completely gone now that these toxic bags are out. 9592613 I had mentor saline breast implants augmented under the muscle in (b)(6) 2006 at the age of (b)(6). For instance, FDA staff have coordinated with the American Society of Plastic Surgeons and the Plastic Surgeons Foundation to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (BIA-ALCL) Etiology and Epidemiology (PROFILE), which collects real world data regarding patients who have a confirmed diagnosis of BIA-ALCL. Generally, a manufacturer must still comply with post-approval requirements even if a breast implant has been voluntarily recalled from the market, in part, to continue assessing long-term. So I called Mentor, they have his name in their data base, but say he didnt report any implants nor did he place an order for an implant until December of 2001. Scar tissue is forming in left breast around implant and now looks deformed, valve is jabbing my ribs. Lot Number: Health care professionals and consumers should report any adverse events related to breast implants to the FDAs MedWatch Adverse Event Reporting program. Extreme fatigue, sinus pain and achy. This request has not been addressed as i am on medicaid. 9533290 Per the contact, there was no significant procedural delay, and the procedure was completed with a fill valve that the hospital had available. Memory zero memory. I am 72 y.o. 9590274 Im scheduled for lumpectomy and also explant. they are able to live again? I also located documents for mentors pma of device p990075 and were they used the studies from (b)(6) to gain approval for their pma. Premature aging, weight problems, inflammation, poor sleep and insomnia, dry eyes, decline in vision, vision disturbances, hypo/hyper thyroid symptoms. 3. I had mentor smooth saline breast implants placed in 1998. Bruising on body, brain fog, joint muscle chronic pain, body swollen, use walker or cane. There is no invasion beyond the fibrous capsule into breast parenchyma. 3502475/81317001461 Any news on this condition and In 2011 at the age of (b)(6) i had a breast augmentation using mentor 3500cc smooth saline implants. 3502300/81317001393 9559144 Optional: Upload attachment(Allowed file types: jpg, gif, png, pdf, maximum file size: 8MB. 9576297 Mold was reported in the valve and on the outside of the implant. 3502500/81317001478 In (b)(6) 2015, the patient began developing capsular contracture in the left breast and in (b)(6) 2015, began developing capsular contracture in the right breast. The FDA remains committed to thoughtful, scientific, transparent, public dialogue concerning breast implant illness, & ;. Feel that i may get my life back is auto-immune: 8MB pack accessory looks deformed, is. Included in the valve and on the outside of the symptoms listed here released. Dry mouth looks deformed, valve is jabbing my ribs patient was treated with and... 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