Here is my list of health issues, that began in 2011. They felt i was depressed with four kids. 9554350 i want my life back, or at least the chance. Now Im full blown deteriorating. I would not have been able to stand on my feet for that long before, when i had implants. A 10-year post-approval study to assess the long-term clinical performance of the device. 9538571 I had mentor smooth saline with silicon shell breast implants implanted in (b)(6) 1999. 9614478 9615517 The patient also had low white blood count, positive ana, elevated monocyte level (13%), full body inflammation, massive weight gain, brain fog, tinnitus, major fatigue, memory loss, new onset allergies, skin condition on the knees, rashes, knee/shoulder throbbing, inflamed joints, painful breasts, and hand and wet swelling. All i want is for my original breasts to look normal and not have the muscle flex deformity. 9555925 Anyone, who enters my world must be fragrance free or i get an automatic headache. Link. Ive been in many MVC & shrugged it off as that is what led to my disabilities. Do you think that made a difference in the muscle deformity? On (b)(6) 2016, the patient was diagnosed with bilateral stage ie alcl (cd30 positive, alk negative) via aspiration cytology. Recall Monitor is not endorsed by, or is an official product of the Government of Canada. 9559882 I guess its best to contact my plastic surgeon? Shortness of breath, night sweats and hot flashes, nausea, lightheadedness, brain fog, poor concentration. 9563098 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. Eye floaters, hip pan, can barely walk after sitting. 9540916 9583793 Link. Consider including a copy of this recall letter when communicating. My sickness started about a year later. Our reporting is not done yet. They opened another implant for the missing items and procedure was completed. No one should have to live like this, no one should. So much pain and terribly weird sensations, sensitivities and i was only (b)(6). Link. 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. Other financial assistance (from date of implant) Up to $2,000 for capsular contracture (Baker grade III/IV) for two (2) years. 9543358 9536098 It is hard and painful. Breast implant illness is a real condition and needs to be explored further and of public health concern. I went from a (b)(6) muscular athletic woman to a (b)(6) frail woman who was malnourished because her body no longer had the ability to absorb nutrients. I had mentor saline implants for 17 years and had a list of health problems from them. I was forced to go to er on (b)(6) 2017, and then to top it off, they are not staffed with an er md? My youngest adult son of three children told me there are many women reporting these issues. It was reported that a female patient underwent a breast augmentation with saline mentor breast implants of unknown type and experienced digestive issues, joint problems, lowered immune system, food sensitivities. 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. I want to get the implants taken out, but cant afford to do so. 9587067 Link. I still didnt know if the cause of my health problems was the implants, but it was like looking into a mirror. Muscle pain, back pain, gingivitis even with excellent oral hygiene. Approx 6 months after having breast implants, i was diagnosed with hashimotos thyroid disease, which is auto-immune. MENTOR Saline Breast Implants | Recall Monitor MENTOR Saline Breast Implants Health Products Mar 10th, 2022 @ 04:00 AM Just found out about this recall? 9614989 Bedridden 9 years and on narcotics for pain. 9576454 9567890 I was a health woman before I put them in and wish I never had. 9551036 9546779 I have almost ALL BII symptoms. Affected products Filter items Showing 1 to 3 of 3 entries Show entries Issue This needs to end. Ive had tests done and never anything found. 9578300 9533292 Post-approval studies (PAS) are conditions of device approval. 9631722 I have an abscess filled with pus on left breast and told him i felt right really had changed he wanted money up front and also stayed along with dr. (b)(6) that capsule did not need to come out. Mentor combo gel silicone/saline mammary prosthesis x 2, above muscle did not feel well, developed a severe capsular contracture. I also tested positive for lyme disease. No patient consequence was reported. How many years did you have them in??? Lot Numbers: The manufacturer had poor follow-up rates with patients. After approx 7 yrs i started having problems communicating. I take vitamins and try to eat healthy. FDA Documents: Approval Date: November 17th, 2006 Recalls FDA Overview - Mentor MemoryGel [] I have felt as if i was dying. All of this symptoms that are listed I deal with daily along with and more recently, breast pain and tingling. 9544817 Upon follow-up, it was confirmed by the patient that the symptoms were experienced three months after the implantation and they are slowing going away after the explantation. He has health issues that are related to the toxic exposure while in womb of the leaking implants. Link. 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). Please do something. There was a stalling hair loss for a period of time, but resumed fall out with complete hair loss by (b)(6) 2014. Since explanting, all of my health issues are gone. I feel my breasts are ruined forever now. 9617818 I will explant next week to get my life back. 9619316 There was no previous history of autoimmune disease. 9629493 I believe the bodys eventual reaction to the implants aged me prematurely. Lot Numbers: Started showing symptoms in 2012. 9561861 Fda confirms all are bad, then recall any implants and make mentor, dow corning, allergan, etc pay for full explanation of all implants, including capsule and repair damage done to womens bodies. Manufacturer Reason. He believed i had sleep apnea. Extreme anxiety, numbness tingling, severe joint pain, brain fog, memory loss, confusion, vision problems, major food allergies, difficulty walking, malabsorption, breathing issues, muscle atrophy, hormonal issues. 9582572 I couldnt eat anything without instantly bloating. I had a right ruptured mentor breast implant that was removed and replaced on (b)(6) 2002. 9615896 Link. 3501660/81317001270 For 10 years my body battled the toxins, biofilm, heavy metals from the implants and finally gave out trying. Link. 9602765 9541226 Up to $3,500 for capsular contracture (Baker grade III/IV), double capsule , and late seroma complications for 10 years. Any news on this condition and Link. After seeking medical attention for this, i learned through labwork. A search has been done in the FDA post-approval study database for P990075 but no search results appeared. Who do you recommend remove my implants? Lot Numbers: I have suffered numerous health problems that i now attributed to the implants: chronic fatigue, cognitive dysfunction, muscle aches, joint pain and soreness, hair loss, dry skin, eyes, mouth, easy bruising and slow healing of wounds. 9546778 I believe i have bii (breast implant illness). 1. I had breast implants in 2005, mentor smooth round profile saline. 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. Hypo/hyper adrenal symptoms, estrogen/progesterone imbalance or diminishing hormones, low libido, slow healing of cuts, and scrapes, easy bruising, throat clearing, cough, difficulty swallowing, choking, reflux, metallic tastes, vertigo, gastrointestinal, and digestive issues. The destruction they cause is not ok. 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. 9551034 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. Subsided after 7 months of treatment. 9595692 9547114 9532947 9554349 It was reported that a female patient was implanted with mentor smooth saline breast implants in 2002. 9594633 9553668 9566957 Redness was noted on the left breast, and bilateral pain/burning was experienced approximately 5 years post-procedure. I had so much tissue and muscle wasting and weight loss. Testing was done immediately as well as steroid treatment and then other immune modulating drugs. I began having severe heart palpitations so i wore a heart halter monitor with no major findings. Link. A patient reported that she underwent cosmetic breast surgery using mentor saline implants for primary augmentation in 1986. Now i see it because i was part of these studies and not f/u with. I suppose that its only an anecdotal report and that correlation does not equal causation; and perhaps my symptoms were not due to breast implants, since i cant prove it. Lot Numbers: 9574051 MENTOR MemoryShape Breast Implants MENTOR Saline Breast Implants FDA Approved Made in the USA Implant Fill Proprietary cohesive gel which holds together uniformly to better resemble a more natural look and feel Proprietary highly cohesive gel that retains shape and has a natural feel. 9563942 I have had mentor textured implants for 19 years. I am 72 y.o. 3503290/81317001621 Lot Numbers: Therefore, all known case details are provided and no additional information is available. Doesnt matter I want to feel healthy . I had saline breast implants in 2007. Low white blood count. 9578066 Manufacturer Mentor Texas, LP. 3501695/81317001324 9546175 I have paid so much money to deductibles, medicine, out of pocket, you name it. 9537342 Mentor saline breast implants in 2001 over the muscle. Thank you for your time. 9553337 He is wonderful and said I was having a reaction to the implants, and that they needed to come out immediately. 9540918 It was reported that a (b)(6) caucasian female patient who underwent primary breast augmentation on (b)(6) 2009 developed bilateral baker grade unknown capsular contracture. Functioning in life is difficult and painful. for Recall. 9580876 Pain, i underwent ultrasounds and blood tests again, no findings. Which I was not asked to participate in, nor aware of. I believe this is all due to my saline mentor implants. 9535132 However, in October 2021, Mentor initiated a voluntary recall of its smooth, round saline diaphragm valve breast implants with expiration dates from January 01, 2025 to September 30, 2025. Mold was reported in the valve and on the outside of the implant. This is no coincidence, and women are getting more sick every day that passes with breast implant illness. I have all the same symptoms and after finding a site for women in the Northwest with the same problems I am taking them out. Link. I had severe brain fog and memory impairment as well as headaches, strange blanket-wrapping sensations, scalp pain, and constant fatigue. 3501640/81317001232 Lot Numbers: I had saline breast implant in 2005. 9595691 I had an ultrasound which showed nothing and I am now waiting for my dr. to get back to me. It was reported that a female patient underwent bilateral explantation of mentor smooth round high profile saline breast implants. No extended hospitalization was required. Lot Numbers: I have a lung issue going onbrochastosis and The patient reported severe nipple pain, fatigue, joint pain, hair loss, and overall sickness. If you have a chance, please also fill out a MedWatch Voluntary Reporting Form to the FDA with your symptoms and history progression similar to these reports submitted above so it can be documented with the FDA and then likely be submitted to Mentor. Visual contrast sensitivity and human beta growth factor tests were administered. Im feeling lost & consumed with chronic pain. I continue to work, but have such horrible brain fog that it worries me. 9616497 Hi Mary, gel indicates you have silicone breast implants. Customer Service. 9612273 Didnt feel as strong at the gym wrote it off as low iron. I made several call backs, no assistance. Sent to cardiac physician who diagnosed me with cardiomyopathy by reviewing the ultrasound and other tests. I spent years and probably thousands of dollars going to drs for testing, after testing and every dr said it was absolutely not my implants. What i know now to be breast implant illness began 5-6 months after i had augmentation with smooth saline implants. I was healthy, more than healthy. The patient also experienced seroma. 9531108 I was actually sick from 2008 2015 from mentor saline breast implants. I wish these side effects and possibility for this happening would have been explained to me. 9611963 9594299 I am very healthy, eat healthy, exercise, and live an overall healthy lifestyle. 9614772 About 23 years ago i was implanted with (b)(4) saline breast implants. Link. Do you work in the medical industry? Lot Numbers: 9608063 Over the next 6 years i began to experience various symptoms such as daily headaches, insomnia, anxiety, and brain fog that i just wrote off at the time. Bruising on body, brain fog, joint muscle chronic pain, body swollen, use walker or cane. Some patients have died from BIA-ALCL. Trying to figure out what to do. 3501635/81317001225 All tests came back as normal. But after seeing further specialist they said the sle was not my genetics but being caused by an autoimmune response to an unk source. Was given two weeks to live if no treatment. 9535385 No doctor will address issues, none not even physical. God Bless everyone, its nice to know Im not crazy! Joint pain, lethargic, slow to heal, sensitive to heat, cold extremities. 9571293 9565714 9612275 I ended up having to leave my job due to these disabilities. Also, the valves in the implants were faulty and had mold in them when they were removed in (b)(6) 2016. This is not ok!!!!! Re-do surgery done on (b)(6) 1993. 9567889 I have been diagnosed with fibromyalgia, uterine cancer, ovarian cancer, chronic fatigue, food allergies, joint pain etc. I ultimately explanted in (b)(6) of 2016. 3501650/81317001256 9590273 I then began having issues with female health, cysts during ovulation, fibrous dense breast tissue that eventually also led to cysts. Right had capsular contracture. 9527187 I now have heart issues, elevated blood pressure, inflammatory arthritis, lyme disease, morgellons, ulcerative colitis and neuropathy. 9583026 Her email is [emailprotected] and phone number is (301) 796-6134. Lot Numbers: 7. Mentor Saline implants in 1998. Link. 9543628 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. 9558225 They were very ripply as well. Link. I was on biologic drugs several years without any relief of joint pain or swelling. 3503500/81317001683 9596093 I had an mri conducted with and without contrast and saw an ms specialist who was not concerned that i had ms. I called Mentor to ask questions but they said I need to talk to the doctor that did the surgery as he was supposed to give me a brochure. Product: Mentor Smooth Round SPECTRUM Post-Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048: Code Information: Lot Number: 7377332: . 9549490 9570168 Link. It was reported that a (b)(6) year old female patient who underwent breast prostheses implantation in 2009 with mentor saline smooth round moderate plus profile implants 350cc (catalog # 3502350, lot # 5915659) experienced bilateral discomfort and aching. 9542800 9529384 I hope your explant was successful. The FDA requested the voluntary recall from Allergan after a "significant increase" in cases of a . Thank you friend, hope youre feeling better! I was healthy prior to 5 years ago, currently show autoimmune symptoms with neg blood work. His name is Dr. Bradford Roberg in Crystal Lake, IL. Over the last year that i had my implants, i became so sick, i felt like i was dying. (b)(6). 9538574 I had a full hysterectomy six months after getting the implants. I have been diagnosed with panic attacks, multiple sclerosis, r/a, fibromyalgia, chronic fatigue syndrome, raynauds disease, thoracic outlet syndrome, chronic insomnia. For my original breasts to look normal mentor implants recall list not have been diagnosed fibromyalgia... To 5 years ago, currently Show autoimmune symptoms with neg blood work body!, but cant afford to do so human beta growth factor tests were administered removed and replaced on b... A mirror horrible brain fog, joint muscle chronic pain, body swollen, use walker or cane and. 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