Examine inventory immediately to determine if they have product subject to this recall on hand and quarantine such product(s). Mentors failure to address these concerns and comply with its post-approval study requirements is a violation of the firms pre-market approval order. 9572393 In (b)(6) 2018 routine annual mammo showed the left breast was folding over. 9538572 9558224 I want them removed as soon as possible because i know they are toxic and my body is reacting to them. The health consequences of a ruptured silicone gel breast implant have not been fully established. for Recall. I will explant next week to get my life back. My blood pressure is no longer high, i have zero neck or shoulder pain, and almost all of my other symptoms have went away. I explanted a few months later and within a month i had cancer. 9585573 Rx meds: none, still have implants as date hasnt been scheduled quite yet for explant. Link. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. 9546778 Same here. What i know now to be breast implant illness began 5-6 months after i had augmentation with smooth saline implants. 9576454 Some insurance companies with assist i having them removed if there is a rupture or they were implanted for reconstruction due to cancer, but i could not find a plastic surgeon that would take them out with insurance paying. 9553671 9541787 I even forgot to take my morning eye drops yesterday because they were moist and didnt hurt. 9541785 I recently explanted in (b)(6) 2016. Further on March 22, 2021 in Philadelphia, the law firm Berger Montague announced that many claims for injuries arising from the recall of Allergan's Biocell textured implants will now proceed to Discovery, read more here. Which led to an ablation attempt and eventually ended with hysterectomy last year. I started having serious difficulty breathing at all times, and especially when laying down at night. 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. This mold caused me to be very sick. i want my life back, or at least the chance. Additional information was obtained: the procedure was not canceled as the physician continued the procedure. In 2005, i had mentor smooth saline implants placed above the muscle. 9614987 9541465 9608405 During routine set up, the physician found that the package of the implant did not contain the dome pack accessory. In (b)(6) 2009, i had a rupture of the left breast implant and (b)(6) 2009 had both replaced with mentor smooth saline moderate profile. An explant surgery on (b)(6) 2017, left was leaking and partially deflated. I had my explant on (b)(6) 2017 and only one week post op i can tell a huge difference in my dry eyes and mouth. Lot Numbers: The FDAs actions today are part of the agencys ongoing commitment to its public health mission of ensuring patient access to safe and effective medical devices. 9597741 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. Shortness of breath, frequent urination, numbness/tingling sensations in upper and lower limbs, ear ringing, sudden food intolerance and allergies, vertigo. Link. This felt like something physical. I have had mentor textured implants for 19 years. I worked as a (b)(6) for 17 yrs but started having problems with memory resulting in mistakes in my work which had never happened before. Lot Numbers: An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements. 9579266 9574053 My hormones are completely of whack. 9533839 My vision became blurry, i had difficulty getting a full breath, my anxiety became worse, and i often felt as though i was going to pass out. There should be some kind of warning about the dangers of breast implants. 9564916 FDA Determined. 9541783 The implants were intact upon explantation. 9550673 9625685 I couldnt eat anything without instantly bloating. Link. On monday (b)(6) 2017, i went to (b)(6). 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. Link. 9559882 9611048 And continue to get sick today. 9614988 Please do something. Link. I have several autoimmune diseases and symptoms related to the implants. 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. 9539274 I have been sick with countless sinus infections, gerd, leaky gut syndrome, loss of vision, headaches, vertigo, decreased libido, hormonal imbalance, food allergies, hair loss and breast masses at the last three mammograms. They should be remove from all surgeries. 9613076 9574051 9540917 The FDA welcomes public dialogue about breast implant safety and risk at the upcoming public meeting of the General and Plastic Surgery Devices Panel at the FDAs headquarters in Silver Spring, Maryland on March 25-26, 2019, which will also be available via webcast. 9611963 Irvine, CA 92618. This sickens me. I feel all breast implants are dangerous and are killing women. The fda allowed their pma with the conditions to add the (b)(6) into the post-approval study which was a 10 year f/u mentor stated to the fda that they attempted to contact and mail enrollment packets to these women but couldnt locate the majority despite the data base they had and was part of the fda rules to save each device and the person receiving them. 9614772 Manufacturer Address Mentor Texas, LP., 3025 Skyway Cir N, Irving TX 75038-3524 Manufacturer Parent Company (2017) Johnson & Johnson Source USFDA The patient then had an infection and underwent explantation without replacement. I had a metal taste in my mouth, tinnitus, chronic pain, chronic fatigue, depression, brittle hair and nails with ridges, +ana test, thyroid levels off and left scapular pain so bad i wanted to overdose and die. 9527187 9595425 9584309 9570472 One doctor said he felt i may have fibromyalgia and another said maybe the beginning of osteo-arthritis. 9534032 I was 100% healthy before the implants. PVCs months after & hyperthyroidism, hair thinning, anxiety ALL few months after saline smooth implants. I have a lung issue going onbrochastosis and The correlation makes sense to me. 9614477 9568917 Here is my list of health issues, that began in 2011. 3502475/81317001461 I was able to coach my daughters basketball team this year for the first time ever. 9555922 As part of the Medical Device Safety Action Plan, the FDA committed to streamlining and modernizing how the agency implements postmarket actions to address device safety issues to make responses to risks more timely and effective, including taking actions against manufacturers when their postmarket studies are non-compliant with any study requirements. 3501620/81317001195 the patient underwent testing but everything returned negative for disease. The mentor spectrum saline implants were the devices implanted at the time of diagnosis. 3* *Based on key complication rates (rupture and capsular contracture). 3501640/81317001232 9563943 Ibs, osteoporosis, told i have lupus and ra, but negative blood work. How is your recovery going? 3501645/81317001249 The patient did not receive chemotherapy or radiation therapy. It was reported that a female patient who underwent primary breast augmentation with mentor smooth round moderate plus profile saline implants (catalog #3502450, (r) serial #(b)(4), (l) serial #(b)(4)) in (b)(6) 2015 underwent bilateral explantation on (b)(6) 2017. Biopsy results from several of the lesions revealed only generalized inflammation. 3503270/81317001614 Lot Numbers: I am bedridden and in a state of intractable pain. I also did genetic testing and i am now 4 times fold for celiac, cancer and 90% likely to have breast cancer. I love my breasts but I have SO MANY of the symptoms listed here. It wasnt until i discovered a website about breast implant illness that i put it all together. I had saline breast implant in 2005. Exactly 3 months later i began having pain and swelling in my neck. Therefore, no additional information is available. 9584310 9527434 3502425/81317001447 9570471 I was depressed, no one knew what was wrong. 33 Technology Drive. Youll have up to two weeks of downtime while you heal. 9622517 I was given chiropractic and physical therapy treatments that did not help. 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. Their reactions mimic mine so i know that heavy metals and chemicals have been passed through to them in utero and while breastfeeding i lost a lot of my eyelashes toward the end, and my hair thinned. 9565269 9556176 Mentor sent an Recall Notification letter dated March 27, 2017 was sent to . She also claimed that the implants caused harm to her children during pregnancy and breastfeeding as her childrens immune system were over-reactive to everything. 9576971 9555925 I am totally suffering also. I was told by my plastic surgeon that they were safe and never warned of the dangers, including that the outer shell is made of silicone with almost 40 toxic chemicals. Which I was not asked to participate in, nor aware of. Ive been reading endless stories online. Joint pain, hair loss, heart palpatations, foul body odor, incontinence (relating to muscle issues) rash of autoimmune responses. The US Food and Drug Administration (FDA) has reviewed the materials used in the manufacture of MENTOR Breast Implants and determined that the implants are safe and effective. I lost my hope until i realized that the root of all of my problems started when i got breast implants. 9582184 The patient has no history of medical problems. 9596801 Im feeling lost & consumed with chronic pain. If i had known they would make me sick and i would have pain in my chest and ribcage, i would not have had the implants. But no return phone call yet. Hashimotos thyroiditis, rheumatoid arthritis, scleroderma, lupus, sjogrens syndrome, nonspecific connective tissue disease, multiple sclerosis, symptoms of or diagnosis or bia-alcl lymphoma. While processing the returns, maintain a copy of this notice with the product subject to this recall and keep a copy for your records. Patient was under general anesthesia for 4 hours (from 7:46am to 12:06pm). Labs show inflammation in my body, which is likely due to the implants. Affected products Filter items Showing 1 to 3 of 3 entries Show entries Issue I was told by my surgeon that since silicone was banned that i would need special approval to get these implants. Link. I grew up very athletic, so this was like dying. All of this symptoms that are listed I deal with daily along with and more recently, breast pain and tingling. 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