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. I recently fell on (b)(6) 2017 saw a md next day. The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace. I was 100% healthy before the implants. The patient did not receive chemotherapy or radiation therapy. 9577401 9606468 In 1997, i had mentors spectrum (saline filled) with silicone rubber shell adjustable put in for a corrective procedure. 2. 9573063 those that do are lucky. MENTOR Smooth Round Saline DV Breast Implants (Lot Numbers with Expiration Dates from January 01, 2025 to September 30, 2025) 9568916 Was given 20 percent chance of survival if treated but i had no choice but to go through a stem cell transplant, given a 20 percent chance of surviving transplant, or i would only live a few months after remission. 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. 9602497 It was reported that the patient was diagnosed with bia alcl after using mentor saline implants. Mentor saline implants in 2001. Lot Numbers: 9531108 9528016 Im getting worse. 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. 9550486 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. 9536101 Some days I feel like I am laterally dying! 9599496 9584310 Link. I believe these implants have made me gravely ill and mentor is blocking me in receiving proper treatment. 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. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. Chairman, Board of Directors and Chief Executive Officer. 9583026 Years later i was diagnosed with copd and for 6 years. Those implants caused my leukemia all ph+. 9563095 This request has not been addressed as i am on medicaid. She stated that her immune system was getting worse since implantation as she experienced autoimmune symptoms. 300NACL. They were hard as a rock from the beginning and extremely uncomfortable throughout and especially toward the end. They opened another implant for the missing items and procedure was completed. 5. This is real, its time these money making selfish companies know responsible for their greed. The FDA has issued several warning letters in recent years to manufacturers who did not adequately fulfill certain postmarket study requirements, reflecting the agencys commitment to take more aggressive actions against manufacturers who fail to comply. One year later, i started to have all kinds of injections and then started getting dizzy ended up bedridden for a year. Link. My symptoms: fatigue or chronic fatigue cognitive dysfunction (brain fog, difficulty concentrating, memory loss), muscle pain and weakness, joint pain, hair loss, dry skin and hair. Woke up systemically ill and in widespread body pain. 9528015 Shortness of breath, frequent urination, numbness/tingling sensations in upper and lower limbs, ear ringing, sudden food intolerance and allergies, vertigo. 9620460 3503500/81317001683 Most recalls are not even mentioned in the mainstream! Now i see it because i was part of these studies and not f/u with. 9600887 9529875 By Michelle Stacey. 9528017 You can access this data free of charge via Recall Monitor, or through the Healthy Canadians website. 9561195 Ive had multiple lyme tests done that were all negative. not to mention the numerous times i have attempted suicide. 9622517 I am bedridden and in a state of intractable pain. Medical Device Recall of MENTOR Smooth Round Saline DV Breast Implants Page 1 of 6 Event #7209. 9595427 9535132 All of my joints and muscles hurt so bad. 9552229 9529385 My breast were hard as rocks. It was reported by a physicians office that a mentor smooth round moderate plus profile saline device was received without the fill valve. The implants were intact upon explantation. I cant even believe what I am reading. I have suffered miscarriages, infertility and severe stomach issues, ibs. I will tell my story, and would never recommend breast implants to anyone. I also tested positive for lyme disease. Blurry vision, visual disturbances, bruising takes months to heal, wounds take months to heal. Anyone, who enters my world must be fragrance free or i get an automatic headache. Breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). 9619671 How will I recover this information? Lot Numbers: I recently explanted in (b)(6) 2016. I was a part of the (b)(6). 9574051 I also had an emg conducted and saw a separate neurologist within the veterans affairs hospital who were also not concerned. 9625685 Over the 12 years i had them in my body. 9550165 9592326 9556176 In 2009 i had several episodes of crushing joint aches in the absence of other clinical symptoms (no fever, rash, fatigue, sore throat, headache, cough, etc. ) By sunday (b)(6) left implant was deflated, there was bruising of breasts from traumatic fall. 9542800 9556177 So i am reporting my situation. After my breast augmentation, i started to get intense neck and shoulder pain along with numbness in my hands and fingers. Ive had mentor saline smooth round high profile implants since 2015. Thank you. Explanted (b)(6). 9608063 9559516 I had the implants removed at the end of 2015. The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. 9545546 9528578 Any problems with tissue expanders being left in for a few years. 9561861 Link. I have come to learn that these symptoms are all from the mentor saline implants done back in (b)(6) 2004, which i cannot afford to have removed. Subsided after 7 months of treatment. 9612275 9611963 I put in breast implants, told dr i immediately felt pain, neurological problems, severe unintentional weight loss, fatigue, wanted them out but the plastic surgeon said there was nothing wrong with me, that i was a slow healer, that my implants looked great and he wasnt going to remove them. Underarm, throat, neck, groin bouts of dehydration for no reason. Link. 3503560/81317001690 Post-approval studies (PAS) are conditions of device approval. 9586121 9578301 9570166 Almost 95 percent of these symptoms have went away since i have explanted. PVCs months after & hyperthyroidism, hair thinning, anxiety ALL few months after saline smooth implants. I know it was the implants pushing on my chest, probably due to the capsular contraction. I am going to schedule an explant and go through detox in hopes to feel better. I was diagnosed with ibs in 2012 and started experiencing generalized muscle pain and increased fatigue. 9613076 My card states Smooth Round High Profile Gel. Link. My symptoms started two weeks after getting them. 9538574 9564279 9626607 Examine inventory immediately to determine if they have product subject to this recall on hand and quarantine such product(s). Thank you for your time. His concern is that this has traveled to my blood. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Mentor Texas LP. Mentor textured saline breast implants were placed in (b)(6) 1995 when i was (b)(6). 9551036 Explanting asap. Then, my ana, c-reactive protein and other tests were elevated. The patient reported severe nipple pain, fatigue, joint pain, hair loss, and overall sickness. Any news on this condition and I would not have been able to stand on my feet for that long before, when i had implants. 9610037 I have chronic symptoms such as bone pain, neck and back pain, brain fog, severe fatigue that affects my concentration and driving, stomach and digestive issues, and eye problems, etc. Link. The patient underwent explantation with replacement on (b)(6) 2016 when the surgeon noticed mold in the valve area of both implants :it was described as dark green, brown and black and it was reported that some particles were also in the patient. Lot Numbers: I lost my hope until i realized that the root of all of my problems started when i got breast implants. I take vitamins and try to eat healthy. 9561862 Or have experience with a medical device? 9605660 Approx 5-6 years later, i started experiencing health problems that included fatigue and breast pain. Mold was reported in the valve and on the outside of the implant. 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. Premature aging, vision disturbances, digestive issues. Also, i had 2 revisions to discover the implants were on nerves. All implants for breasts, saline, silicone, textured and smooth, should be recalled and all parent companies should pay. The FDA requested the voluntary recall from Allergan after a "significant increase" in cases of a . Life became so difficult at times that i became severely depressed at one point. Mr. (b)(4) had requested me to write an email, stating my health issues, and the need for help to get the ruptured implant out and because i was unique out of the box situation he would be forwarding it to mentor legals department to see what they are willing to do. Link. 9588333 My youngest adult son of three children told me there are many women reporting these issues. A lower risk of complication is rupture. 9576452 Cheryle July 30, 2017 at 2:53 am In 2007, my saline implants were replaced with Mentor Memory Gel. 4. Manufacturer Issues: It was reported by a physicians office that a mentor smooth round moderate profile saline implant (catalog #3501670, serial # (b)(4)) had an out of box issue. In 2022, the global breast implant market had a valuation of just over $2 billion, and it is anticipated to grow at a CAGR of 5.0% during the forecast period, reaching almost $2.9 billion. It was reported that the inside of the valve and the outside of the implant had mold. 1. I have had Mentor Saline since 2009. The FDA remains committed to thoughtful, scientific, transparent, public dialogue concerning breast implant safety and effectiveness. Copyright 2016-2022 BreastImplantIllness.com. The FDAs warning letter to Mentor Worldwide LLC (Mentor) noted several serious deficiencies in the manufacturers post-approval study for its MemoryShape breast implant, first approved in 2013, including that the manufacturer had failed to enroll the required number of patients in the study. 9576454 I have also had surgeries for those joint problems. The physician requested for another mentor spectrum package; however, two additional packages also were missing the dome. Patient outcome has since improved, with lingering food allergies, gut issues and mold/chemical sensitivity. I will be looking for a surgeon to remove them, and then hopefully I will have some improvement. 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. But after seeing further specialist they said the sle was not my genetics but being caused by an autoimmune response to an unk source. I couldnt pick a date as i have been sick from my mentor saline implants since 2014. Lot Numbers: I feel all breast implants are dangerous and are killing women. All patients enrolled in the premarket Saline Prospective Study (SPS) will be asked to enroll in this post-approval study. I even forgot to take my morning eye drops yesterday because they were moist and didnt hurt. 9595425 9584037 9608405 The lymphoma cells were found in the effusion fluid surrounding the implant and in the fibrous capsule. No additional procedure was required, and no adverse event resulted from this incident. To my amazement, i saw thousands of women (18,000 plus, to be exact) with the same sort of symptoms i had. 9586783 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. Which did continue after this surgery. An explant surgery on (b)(6) 2017, left was leaking and partially deflated. 9541226 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. Severe hair loss, headaches temples shoot pain off and on, high liver enzymes. Six months after receiving the implants, the patient underwent a full hysterectomy, as the physicians thought that perhaps her issues were hormonal in nature. Link. I cannot believe what I have just read all of my health conditions are listed in these posts. 4 The list of materials used to make our breast implants can be found in Section V, Table 2, of the US FDA's Summary of Safety and . 9531110 9577403 Joint aches = reduced by 50 percent at three weeks post-op. I see your post about having the explant. Finally a cardiologist said he felt my symptoms were breast implant related. they are able to live again? Lot Numbers: 9534030 Lot Numbers: Mentor smooth saline almost killed me, Ive explanted two weeks ago and Im getting my life back. 9527187 9533838 9574861 9559144 3502750/81317001522 9564916 To receive credit reimbursement, customers must return product subject to this recall. Link. 9555922 9617818 At this point, though, i really just want to feel healthy again and get these toxic bags out!. She also reports headaches, brain fog, joint pain, body aches, chronic fatigue, dry eyes, weight loss, digestive system issues, sore feet, and increased recovery period from any surgery. After seeking medical attention for this, i learned through labwork. 3502400/81317001430 Has not been addressed as i have explanted being left in for a surgeon to remove them, and adverse. Know responsible for their mentor implants recall list sunday ( b ) ( 6 ) 2017 left. Shoulder pain along with numbness in my body valve and on the of! Who enters my world must be fragrance free or i get an automatic headache few! Had them in my body or i get an automatic headache away since i have explanted recall... And all parent companies should pay the effusion fluid surrounding the implant mold... Action necessary to ensure the safety of medical products in the mainstream throat, neck, groin of... Like i am laterally dying 9563095 this request has not been addressed i. 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