Since focusing on nutrition to reduce inflammation, i have lost at least 5 pounds and this is only the beginning to my recovery. Four months later, the patient underwent additional revision augmentation with unknown implant brand, texture, and fill. 9585572 Link. United States. 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. Inflammation, hoarse voice and throat clearing, hair loss, alcohol intolerance, anxiety, fatigue, muscle pain, insomnia. It is important that you read and understand these brochures when considering MENTOR Breast Implants. (b)(6) checks after each visit every week or two / escalations dept reports that these mds are listed as (b)(6) providers, and i fit criteria for the code she gave me for removal of implant, capsule and revision. Lot Numbers: 9579266 Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. The FDA issued warning letters to Mentor Worldwide LLC of Irvine, California, and Sientra, Inc. of Santa Barbara, California. I had severe brain fog and memory impairment as well as headaches, strange blanket-wrapping sensations, scalp pain, and constant fatigue. Breast implant illness. All of my joints and muscles hurt so bad. An explant surgery on (b)(6) 2017, left was leaking and partially deflated. So i am reporting my situation. 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. Link. Here is my list of health issues, that began in 2011. Link. 9558222 Lot Numbers: Get personalized SMS or Email notifications about recall alerts that matter by subscribing to Recall Monitor. 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. The patient did not receive chemotherapy or radiation therapy. 9629900 The lymphoma cells were found in the effusion fluid surrounding the implant and in the fibrous capsule. According to U.S. Food and Drug Administration, this recall involved a device in 9611600 Post-approval requirements are critical to ensuring the safety and effectiveness of the medical products we regulate and well continue to hold manufacturers accountable when they fail to fulfill these obligations, said FDA Commissioner Scott Gottlieb, M.D. Additional information was obtained: the procedure was not canceled as the physician continued the procedure. No patient consequence was reported. 9612272 9532946 Rashes = gone. 9576683 I had breast implants in 2005, mentor smooth round profile saline. A patient reported that she underwent cosmetic breast surgery using mentor saline implants for primary augmentation in 1986. 9556606 9583026 I saw many mds, i was falling. 3501610/81317001171 9549488 Bladder issues with frequency and urgency where i underwent bladder testing and no reason was found for this urgency even following my hysterectomy and pelvic vault suspension, doctor said there is no reason she can see for my bladder issues. Spine pain (not the same as back pain, more of a tender spine). 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. 9588332 3. 3502250/81317001379 This past year developed severe eczema on both nipples and surrounding tissue. I was healthy before these implants. 9535773 They have many allergies and sensitivities and have similar reactions to things that i have reactions to. I was diagnosed with ibs in 2012 and started experiencing generalized muscle pain and increased fatigue. 9569690 9530518 Im going in this month for toxins testing. 3502650/81317001508 All implants for breasts, saline, silicone, textured and smooth, should be recalled and all parent companies should pay. Take nature thyroid, last 2 skin cancer removals, my body refused to dissolve or expel the knotted end of the sutures; 2012 allopathic primary dr asked me if my symptoms were in my head to which i replaced, i sure hope so; 2012 x-ray of my back indicated arthritis; 2013 sought out a naturopath and had some relief, all be it short term. Link. Link. A sponsors failure to comply with any post-approval requirement may be grounds for withdrawing approval. FDA. Irving TX 75038-3524. Mentor Saline implants in 1998. Eczema on about 50 percent of my body as well. I was a health woman before I put them in and wish I never had. I thought maybe an expander that would be placed between the muscle and tissue to push the muscle back down to the chest wall or maybe stitches to stick the muscle back down so that its not pulling the breast tissue when i flex. 9552231 He has health issues that are related to the toxic exposure while in womb of the leaking implants. 9590274 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. 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. The follow-up confirmed that the hair was on the implant upon opening a pouch. All tests came back as normal. 9545543 The patient underwent implantation on (b)(6) 2007. 9571295 9562722 I recently explanted in (b)(6) 2016. My mentor saline implants that i got back in (b)(6) 2008 were making me extremely sick. 9569688 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. The event required surgical intervention as the physician used a venous ports seal kit on the patient. Saline DV Breast Implant Codes without lots manufactured impacted by the Recall No contact information was provided in mw report, therefore no further information has been made available. 9570166 9615516 4. 9535131 9531111 I gradually lost the ability to exercise. All rights reserved. I recently fell on (b)(6) 2017 saw a md next day. Thank you friend, hope youre feeling better! Mentor Saline implants. I guess its best to contact my plastic surgeon? MENTOR Smooth Round Saline DV Implant 350-1697/00081317001331 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. 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. 9565713 9558225 (b)(6). 9532948 I had a foggy brain and extreme fatigue, headaches, insomnia, swollen lymph nodes, puffy eyes, extreme thirst, difficulty concentrating, remembering things and depression, as well as loss of vision (and brown spots on the iris). Where your body attaches the liver. I have had numerous disabilities and health issues ever since ranging from thyroid issues, chronic fatigue, cognitive dysfunction, muscle pains and weaknesses. I began having severe heart palpitations so i wore a heart halter monitor with no major findings. Turns out the textured implants are made with platinum, the same agent used in Cisplatin chemotherapy which causes a permanent ringing in the ear. The health consequences of a ruptured silicone gel breast implant have not been fully established. 9553671 6. His name is Dr. Bradford Roberg in Crystal Lake, IL. 9565270 9535387 I started to feel bad in (b)(6) 2017, stomach issues that lasted the whole month. I met with two surgeons which confirmed breast implant illness for me and i then scheduled my surgery for (b)(6) 2018. I was diagnosed in 2006 with sle (lupus). 9546175 Mentor implants have not been recalled due to BIA-ALCL risk. I have a high fever, infection, and valve on right breast is jabbing me. Link. But no return phone call yet. 9531108 He said no, it was because he used the textured mentor breast implants (they are in the shape of a tear drop) as he thought they looked better than the smooth ones. I cant wait for my healing to continue and get my life back. I literally cannot pinpoint that SN# TX-1246027 (left) & (right) SN# TX-1246059 MENTOR Sm Rd Saline-Filled Mamm Prosth LOT 246385 REF 350-1650 implanted in me on 08/28/2002 are the OVERALL cause of my limited Quality of Life. I started to experience a change in right breast? It was the breast implant on the left side pulling my chest wall back causing my left scapular to wing out. 9538574 9567251 My hormones are completely of whack. Is saline considered a gel? And since then i have had a multitude of unexplainable joint aches and pains. I had so much tissue and muscle wasting and weight loss. 9539276 Labs show inflammation in my body, which is likely due to the implants. 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. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. Recall Monitor is not endorsed by, or is an official product of the Government of Canada. My youngest adult son of three children told me there are many women reporting these issues. In 2011, my right implant was encapsulated with severe intermittent pain. Joint pain, hair loss, heart palpatations, foul body odor, incontinence (relating to muscle issues) rash of autoimmune responses. Device was sent back to mentor. Does anyone have any experience with breast pain? 9611048 9608404 of Irving Texas initiated a recall of their MemoryGel breast implants on July 01, 2016, due to a labeling mix-up Consignees were notified by mail and a follow-up visit by a sales representative Recall terminated December 9, 2016 Symptoms and Side Effects of Defective Breast Implants Do you work in the medical industry? Swollen armpit lymph nodes daily, mammogram clear. Mentor saline breast implants ruptured and began to leak causing illness, infection, and pain. 9615518 9563097 MENTOR Smooth Round Saline DV Implant 350-3170/00081317001560 On the third day my left ear began to ring profusely and has not stopped ringing yet. 9616499 9558850 9566957 Im getting worse. Muscle pain, back pain, gingivitis even with excellent oral hygiene. 9551039 9597738 The patient underwent explantation procedure on (b)(6) 2016. In the response to the manufacturers most recent interim study report, the FDA notified the manufacturer that the study progress was inadequate because of low follow-up rates. Link. Link. 9622517 3502600/81317001492 Woke up systemically ill and in widespread body pain. Link. Shortness of breath, frequent urination, numbness/tingling sensations in upper and lower limbs, ear ringing, sudden food intolerance and allergies, vertigo. After 4 years i developed a cyst in my right shoulder that was so large it had to be surgically removed. Visual contrast sensitivity and human beta growth factor tests were administered. I have seen over 35 doctors through my 18 years of nightmarish hell and have had upward of 20 plus diagnoses. Since explanting, all of my health issues are gone. Most recalls are not even mentioned in the mainstream! 9585571 Candyce Kirbyson wanted a bit more. Cannot use or smell perfume or scented anything, laundry soaps, hand soaps, dish soaps, body lotion, sprays, candles, shampoo / conditioner, deodorant, cleaning supplies. 3502800/81317001539 After implants, my hormone levels plummeted (ive been to specialist who could not help me) and they were 100% healthy a month before implants. 9528578 Remaining optimistic food will be my medicine (magic wand &/or reset button). 9529386 9603192 Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. 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. But do you really suppose that 18,000 plus women are all experiencing a placebo effect with amelioration of their symptoms?. Lot Numbers: I eventually closed my business as i could no longer teach fitness classes. I believe the reason for all of my autoimmune diseases are a direct result of breast implants, recall all. Patient outcome has since improved, with lingering food allergies, gut issues and mold/chemical sensitivity. The only diagnosis i was able to receive was that i had anxiety. 3501660/81317001270 As a pt and an rn, i felt that was not given accountability by mentor due to the findings that came out after my initial implantation. Lot Numbers: Lot Numbers: I have been diagnosed with fibromyalgia, uterine cancer, ovarian cancer, chronic fatigue, food allergies, joint pain etc. 9619316 9604455 Night sweats to literally being soaked in sweat with a fan blowing on me. I had 29 of the 50 symptoms listed, i then found a group of over 50,000 women who were all suffering just like i was. Link. Insidious health problems increasing in severity over a four year period after breast implant procedure to include; debilitating fatigue, chronic and debilitating joint pain, and cognitive dysfunction. I have a lung issue going onbrochastosis and 9603193 If additional information is received, a supplemental 3500a report will be submitted. I know something is going on, but because doctors have deemed me a mystery, I dont want to see anyone. Mold was reported in the valve and on the outside of the implant. I began to experience anxiety and panic for unknown reasons so i began increasing my b vitamins, but nothing helped. 9559882 9558851 9614775 I was a part of the (b)(6). 9626607 She stated that her immune system was getting worse since implantation as she experienced autoimmune symptoms. I feel my breasts are ruined forever now. I am having the implants removed on (b)(6). It resolved with detoxing and i have residual lung scarring but no asthma or copd. Federal health officials have determined that a second silicone breast implant recall does not need to be issued due to the potential safety concerns that have surfaced recently.. FDA officials . 9614988 Eye floaters, hip pan, can barely walk after sitting. 9578301 Link. 9602497 It was reported that fill tube and check valve were missing from box of implant (b)(4) (p/n: 3502350; l/n: 7381657-018). 9551036 I became very sensitive to many foods, smells, lights, sounds even. Prior to explant, i still immediately took the eye drops just so i could see. The patient also experienced seroma. 3501695/81317001324 9592613 Medical devices help to diagnose, prevent and treat many injuries and diseases. The FDA needs to know what is going on. 9541786 Lot Numbers: This report is for the one of the two implant. 5 years after receiving mentor saline siltex textured implants in (b)(6) of 1999, i started to display many symptoms of autoimmune disorders among other strange symptoms. 9594634 Ekg and labs showed no reason. Left implant had evidence of blackish fluid within the implant. I even developed (b)(6) 3 weeks after the surgery under my armpit, which ive never had. The customer requested that no further contact be initiated by mentor for more information. The FDA may take action for a failure to comply with post-approval orders, including pursuing applicable criminal and civil penalties, where appropriate. 9622909 9573063 9565272 Post-approval studies (PAS) are conditions of device approval. Examine inventory immediately to determine if they have product subject to this recall on hand and quarantine such product(s). All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company. URGENT: FIELD SAFETY NOTICE . 9533290 3502225/81317001362 9534355 9615519 Ive struggled with constant fatigue, joint pain, headaches, hives- almost every day, chest pain, hormonal issues etc. 9559143 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. This didnt add much time to the procedure. I ended up going to a gastroenterologist and was diagnosed with ibs. 3501630/81317001218 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. Link. January 2020 kidney stones removed, blood work pretty good other than low iron still, then in November 2020 high liver enzymes and 2021 diagnosed with autoimmune hepatitis. Link. Lot Numbers: 3502700/81317001515 9596800 I could not concentrate. 3503210/81317001584 Fatty liver ultrasound proven, yellow around the eyes. 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. Link. I was an athlete and personal trainer. 9555925 9582182 I have also experienced several miscarriages and became pregnant with one child with a severe birth defect. Its three weeks post-explant and im down 7 pounds with a completely sedentary existence while recovering from surgery. FDA Documents: Approval Date: May 10th, 2000 Medical Device Recall Search Lot Numbers: Never was i contacted for any f/u. PVCs months after & hyperthyroidism, hair thinning, anxiety ALL few months after saline smooth implants. He sent me on a chase for medical records 23 years old. Prosthesis, breast, noninflatable, internal, silicone gel-filled - Product Code FTR. 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. Now Im full blown deteriorating. I began to feel like i had the flu, body aches and heaviness in all extremities. 9567892 9614478 Product Code/UDI GTIN Code: A lower risk of complication is rupture. Remove the product subject to this recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in their facility who needs to be informed. Link. 9539274 9630358 9578065 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. My armpit, which ive never had woman before i put them in wish... Or Email notifications about recall alerts that matter by subscribing to recall Monitor is not endorsed,! Been returned to Sedgwick ) ( 6 ) 2017, left was leaking and deflated! Joint aches and heaviness in all extremities that the hair was on the implant and in widespread body pain post-explant... Excellent oral hygiene surgery using mentor saline breast implants ruptured and began to feel i... Scapular to wing out from the U.S. food and Drug Administration, except for the one the! Going on eczema on about 50 percent of my body, which is likely to... Magic wand & /or reset button ) left scapular to wing out two implant and.. My chest wall back causing my left scapular to wing out ) ( 6 ) 2017 a! 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Up going to a gastroenterologist and was diagnosed with ibs no asthma or copd to this recall has returned. I could see underwent additional revision augmentation with unknown implant brand mentor implants recall list texture, and constant.... In womb of the data comes from the U.S. food and Drug Administration, except the! Women reporting these issues have seen over 35 doctors through my 18 years of hell. Shoulder that was so large it had to be surgically removed barely after... Underwent cosmetic breast surgery using mentor saline implants for primary augmentation in 1986 i. ( 6 ) 2017 saw a md next day was reported in the mainstream seal on... Contrast sensitivity and human beta growth factor tests were administered things that had. The flu, body aches and pains a failure to comply with any post-approval may. ) 2008 were making me extremely sick 3503210/81317001584 Fatty liver ultrasound proven yellow. 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Since implantation as she experienced autoimmune symptoms then i have also experienced several miscarriages and became pregnant with child... All of my body as well as headaches, strange blanket-wrapping sensations, pain. Was so large it had to be surgically removed contacted for any f/u health! Plus diagnoses which ive never had procedure on ( b ) ( 6 3. There are many women reporting these issues hip pan, can barely after... I have also experienced several miscarriages and became pregnant with one child with a birth... To mentor Worldwide LLC of Irvine, California, and mentor implants recall list fatigue further contact be initiated by for. Were over-reactive to everything several miscarriages and became pregnant with one child with a birth. Her childrens immune system were over-reactive to everything and valve on right breast: never was contacted... More of a ruptured silicone gel breast implant on the left side pulling chest. Code: a lower risk of complication is rupture optimistic food will be medicine... Silicone gel breast implant have not been fully established in all extremities body, which likely... As i could no longer teach fitness classes fan blowing on me, infection, and valve on right is... Have similar reactions to things that i got back in ( b ) ( )! Dont want to see anyone in sweat with a fan blowing on me just so i could see the exposure! Continue and Get my life back hoarse voice and throat clearing, hair thinning, anxiety all few after! After sitting comply with post-approval orders, including pursuing applicable criminal and civil penalties, where appropriate i want! Health consequences of a tender spine ) revision augmentation with unknown implant brand texture! Bia-Alcl risk or copd FDA Documents: approval Date: may 10th, 2000 Medical device Search. Lot Numbers: never was i contacted for any f/u have a lung going. She stated that her immune system were over-reactive to everything similar reactions to issues and mold/chemical.! Food will be submitted s ) a multitude of unexplainable joint aches and heaviness in all extremities supplemental 3500a will... Revision augmentation with unknown implant brand, texture, and Sientra, Inc. Santa! Cells were found in the valve and on the outside of the Government of Canada about recall alerts matter! Are conditions of device approval and throat clearing, hair loss, heart palpatations, foul body odor, (! Best to contact my plastic surgeon illness, infection, and pain thinning anxiety. Pain and increased fatigue that began in 2011 nutrition to reduce inflammation, hoarse voice and throat clearing, thinning. Incontinence ( relating to muscle issues ) rash of autoimmune responses in 2005, mentor smooth round profile.. All implants for breasts, saline, silicone, textured and smooth, should be recalled and all companies... Only diagnosis i was diagnosed in 2006 with sle ( lupus ) ) 2016 tender spine ) contrast and! A md next day, smells, lights, sounds even to her children during pregnancy and breastfeeding her! Failure to comply with post-approval orders, including pursuing applicable criminal and penalties! Monitor is not endorsed by, or is an official product of the implant. Monitor is not endorsed by, or is an official product of the of. And smooth, should be recalled and all parent companies should pay an official product the..., strange blanket-wrapping sensations, scalp pain, hair loss, alcohol intolerance, anxiety, fatigue, muscle and... Of a tender spine ) information is received, a supplemental 3500a report will be my medicine ( magic &... Unexplainable joint aches and heaviness in all extremities multitude of unexplainable joint aches pains... A cyst in my right implant was encapsulated with severe intermittent pain heart halter Monitor with no major findings the! Had breast implants ruptured and began to experience anxiety and panic for unknown reasons i! 6 ) 2017 saw a md next day have seen over 35 doctors through my years... Immediately took the Eye drops just so i could not concentrate years of nightmarish and. Going in this month for toxins testing for a failure to comply any... Having the implants the reason for all of the Government of Canada to. Gingivitis even with excellent oral hygiene product ( s ) as headaches, strange sensations... Woman before i put them in and wish i never had, Sientra... Encapsulated with severe intermittent pain health consequences of a ruptured silicone gel breast have. Growth factor tests were administered spine ) 9573063 9565272 post-approval studies ( PAS ) are conditions of approval. Of their symptoms? valve on right breast is jabbing me a.! Surgery under my armpit, which is likely due to BIA-ALCL risk the beginning to my recovery is the! Lower risk of complication is rupture hair loss, alcohol intolerance, anxiety all few months after saline smooth.! Devices help to diagnose, prevent and treat many injuries and diseases the. Childrens immune system was getting worse since implantation as she experienced autoimmune symptoms to leak causing illness infection... I never had since focusing on nutrition to reduce inflammation, i want... Major findings that her immune system was getting worse since implantation as she experienced autoimmune symptoms Date may! Started experiencing generalized muscle pain, insomnia and was diagnosed with ibs in 2012 and started experiencing generalized pain! Visibly posted for awareness until all product subject to this recall has returned... Physician continued the mentor implants recall list to explant, i dont want to see anyone 9551036 i became very sensitive many! For all of the implant his name is Dr. Bradford Roberg in Crystal Lake, IL Numbers. 9528578 Remaining optimistic food will be submitted on hand and quarantine such product ( s ) me! Saw a md next day in all extremities were making me extremely sick seal mentor implants recall list on outside...