3501630/81317001218 9556175 Left implant had evidence of blackish fluid within the implant. 9541785 I cant even believe what I am reading. I had saline breast implant in 2005. Their immune systems are overreactive to everything. 9546778 9599497 Symptoms: horrific migraines, fatigue, constipation, pain and hardening of one saline implant. 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. Examine inventory immediately to determine if they have product subject to this recall on hand and quarantine such product(s). SMOOTH ROUND HIGH PROFILE SALINE-FILLED MAMMARY PROSTHESIS, SALINE-FILLED MAMMARY PROSTHESES WITH DIAPHRAGM VALVE, SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT W/DIAPHRAGM VALVE. There was no patient contact. I had mentor saline breast implants augmented under the muscle in (b)(6) 2006 at the age of (b)(6). Joint aches = reduced by 50 percent at three weeks post-op. Affected products Filter items Showing 1 to 3 of 3 entries Show entries Issue No patient contact information was provided. The event required surgical intervention as the physician used a venous ports seal kit on the patient. 9552231 Re-do surgery done on (b)(6) 1993. I got my implants in 2010. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and fax/email to Sedgwick at 888-912-7086 or mentor7209@sedgwick.com within 3 business days. 9592613 Heat and cold intolerance. 9526975 I will tell my story, and would never recommend breast implants to anyone. 3501660/81317001270 9595691 It was reported that there were brown flakes on the implant that were noted out of box. The FDA needs to know what is going on. 9580415 Approx 5-6 years later, i started experiencing health problems that included fatigue and breast pain. 9551036 Link. 9588333 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. 2. Thank you friend, hope youre feeling better! Allergan Natrelle Silicone Gel-Filled Breast Implants. A few years ago i was having hormone inbalance issues. I also developed asthma, and allergies to foods that were never an issue before. 9567250 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. People are so so sick and we had no warning of any of this prior to getting those toxic bags put in our bodies! So i am reporting my situation. 9556604 9572394 9541466 9541788 Return the BRF even if they do not have product subject to this recall. Immediately, my breathing was cured! Its as if their symptoms mirror some of which Im suffering from. I couldnt pick a date as i have been sick from my mentor saline implants since 2014. Absolutely no auto immune issues in my blood relatives. 9530518 Lot Numbers: Customer Service. 9603192 This is real!!!! The patient has no history of medical problems. 9556177 9534355 9527187 9534353 FDA Documents: Approval Date: May 10th, 2000 Medical Device Recall Search Implanted with mentor textured implants in 1996. Started showing symptoms in 2012. 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. Prosthesis, breast, noninflatable, internal, silicone gel-filled - Product Code FTR. I was never explained of the possible health risks to my immune system and quality of life. In 2008, the patient has a bilateral revision augmentation due to capsular contracture with unknown implant brand, texture, and fill. 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? 9617100 They are toxic in the human body and they harm babies in utero and while breastfeeding. Retrieval study to collect visual examination, physical, and histological dat on explanted implants to determine the mode of failure of implants. FDA Documents: Approval Date: November 17th, 2006 Recalls FDA Overview - Mentor MemoryGel [] 9617818 9558853 9597740 The years following, i had fainting episodes, seizures and all my doctors couldnt explant the source. Too many over all of these years to list, but everything you can think of. Per the customer, the implant did not come into contact with any patient. The same device may have different names in different countries. Approximately two weeks after the procedure, the patient began to experience a number of symptoms, including extreme anxiety, numbness, tingling, joint pain, brain fog, memory loss, confusion, vision problems, food allergies, difficulty walking, breathing issues, muscle atrophy and hormonal issues. 9554350 The patient information was not available. 3502475/81317001461 9540919 I scheduled an explant for 12/02/20. 9585571 MENTOR Smooth Round Saline DV Breast Implants (Lot Numbers with Expiration Dates from January 01, 2025 to September 30, 2025) I have become very clumsy, falling often, due to dizziness when i least expect it. 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. 9604456 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. Prior to explant, i still immediately took the eye drops just so i could see. Mentor saline breast implants in 2001 over the muscle. Body odor every hole chemical sensitivity. I had the mentor saline implants 14 years ago. Link. 9544818 9571293 I am two weeks out from surgery and i am healing every day. (scalp, eye brows, eye lashes, nasal hair, facial peach fuzz). Link. Eczema on about 50 percent of my body as well. My feet were constantly sore and i had to replace my arch supports every 30-60 days because it was like walking on bones, my foot doctor said my bottoms of my feet were the thinnest he had ever seen. This has been going on since Monday. 9602500 9551039 9596396 Capsules were thick, yellowish and my chest full of yellow murk liquid. 9533291 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. 9527436 9555925 9533290 I am (b)(6). I want my breast implants out, as i feel that i may get my life back. 9546176 Lot Numbers: My skin was aging rapidly the last year, and now that the implants are out, the age spots have lightened and i have been complemented on my glowing skin again. Toward the end of the 12 years, i was not able to be on my feet for long and not able to walk or run, other than grocery shopping and the duties of being a mom. Medical Device Recall of MENTOR Smooth Round Saline DV Breast Implants Page 1 of 6 Event #7209. Please help me get all of this out. 3502500/81317001478 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. 300NACL. 9549490 The FDA may take action for a failure to comply with post-approval orders, including pursuing applicable criminal and civil penalties, where appropriate. On (b)(6) 2016 i had to undergo a 7 hour surgery to remove the toxic mentor saline implants that have been deteriorating my health for years. The correlation makes sense to me. In (b)(6) 2017, my muscles began to spasm and twitch constantly all over my body. 9605660 Lot Numbers: Manufacturer Mentor Texas, LP. Explanted (b)(6). 9615895 3502800/81317001539 I got breast implants and theyve made me very sick. During the next 6 months to 12 months i went through hyperthyroidism and then hypothyroidism. I have explanted and i no longer take any psych meds. 9616932 Note: another surgeon in 1996 performed the implantation. 9559143 It made me look like someone with brain damage when i would be talking and all of a sudden either couldnt think of a word i needed to use in a sentence or lose my train of thought completely. my first ones were removed via the area incision and now i have an incision in the inframammary location. Link. I have been in the er at least 5 times due to headaches, heart palpitations, anxiety, etc. Link. Mentor Texas, LP., 3025 Skyway Cir N, Irving TX 75038-3524, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147917, Device Recall Mentor MemoryGel Breast Implant, International Consortium of Investigative Journalists. 9579266 I also did genetic testing and i am now 4 times fold for celiac, cancer and 90% likely to have breast cancer. Link. Patient had implants in for 10 yrs. The only test that ever came back positive was an ana test which my dr said could have been from having mono years ago. This cancer occurs more commonly in patients with textured breast implants than smooth Implants, although rates are not well defined. Recall Monitor is not endorsed by, or is an official product of the Government of Canada. 9596800 I have also had weight gain, allergic to wedding bands, skin rashes on hips, brain fog, fatigue, depression. 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. 9535775 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. 9586121 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 The mentor spectrum saline implants were the devices implanted at the time of diagnosis. The implants were intact upon explantation. 9569247 I had mentor saline implants for 17 years and had a list of health problems from them. Capsular contracture and fungal growth were diagnosed in both breasts/implants upon explantation. Remaining optimistic food will be my medicine (magic wand &/or reset button). 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. Some patients have died from BIA-ALCL. 9563095 9615896 God Bless everyone, its nice to know Im not crazy! I havent even had a cold for at least 2 years or more. 9569688 Based on a decade of research into the safety and efficacy of breast implants, our Mentor Core Study 3 provides evidence to support the unsurpassed design of MENTOR MemoryShape Breast Implants. 3* *Based on key complication rates (rupture and capsular contracture). 9565270 I am making a comeback and looking forward to returning to work in the legal community. 9578066 Link. 3502250/81317001379 I started having serious difficulty breathing at all times, and especially when laying down at night. Im hoping! Turns out the textured implants are made with platinum, the same agent used in Cisplatin chemotherapy which causes a permanent ringing in the ear. Hair falling out, weight gain, lymph nodes swollen, breast pain left side. Youll have up to two weeks of downtime while you heal. There should be some kind of warning about the dangers of breast implants. I cant take it anymore. This is mdr reportable as an additional procedure was needed to complete a reconstruction surgery. I had severe stinging in my hands and feet and an absolutely awful chemical taste in my mouth. His name is Dr. Bradford Roberg in Crystal Lake, IL. Link. Patient was required extended hospitalization. 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. I had mentor smooth saline breast implants placed in 1998. 9619671 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. 9614774 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. No. 9529112 Health care professionals and consumers should report any adverse events related to breast implants to the FDAs MedWatch Adverse Event Reporting program. Im trying to pick a doctor now. Within 6 months i developed autoimmune disorder; candida cystic acne, unexplained weight gain, cold sores, toe nail fungus, brain fog. I was healthy, more than healthy. 9552232 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. I was never explained that i was to be in clinical trials. 9552230 9538080 Ive been reading endless stories online. Mentor sent an Recall Notification letter dated March 27, 2017 was sent to . 9541462 9565271 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. 3. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. 1. There is not a recommendation that women who have had these implants placed explant them. This price does not include mastopexy (breast lift). I hope your explant was successful. A 10-year post-approval study to assess the long-term clinical performance of the device. 9617814 I see your post about having the explant. 9528841 Link. Immediately and every day since my surgery 3 weeks ago, ive had all of the same symptoms reappeared but even worse. My breasts were so deformed from the explantation (muscle had attached to the breast tissue and every time i flexed it pulled my breasts inward) that i decided to have new implants put in to see if it would help the deformity and improve my self confidence. I believe i was left out because the investigators used by mentor were not following up with pts as they should have and i think submitting false f/u reports. Note: Parentheses represent redacted information to protect privacy. 9595427 It was reported by a physician that a (b)(6) caucasian female patient who underwent multiple breast augmentation procedures was diagnosed with bilateral stage ie alcl on (b)(6) 2016. 9608794 Was the surgery difficult and painful? Additionally, the FDA has worked with multiple stakeholders to facilitate the development of the National Breast Implant Registry (NBIR) to provide a platform for collecting additional real world data on the safety and performance of breast implants. I have had years of extensive testing done. 9544817 The box of 300cc memorygel breast implant was labeled with null manufacturing and expiration dates. 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 am now only left with ear ringing and pulsative tinnitus with sporadic muscle twitching and small bouts with anxiety. Ive had chronic infections since these were placed. 9614987 The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. No patient consequence was reported. 9542800 9591675 Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device. I was healthy before these implants. I had hyperthyroidism, hypothyroidism, hair loss raynauds disease. Despite being in total shock that this male muslim doctor decided to go against my choice of implants, within a few days I began to have major symptoms. It was reported that fill tube and check valve were missing from box of implant (b)(4) (p/n: 3502350; l/n: 7381657-018). Painful periods and excessive bleeding. On 1998 experienced cfs, brain fog and was disabled. As of (b)(6) 2016, the patient is alive and has no evidence of alcl. This is not ok!!!!! 9539273 Hi I had Saline, Round I believe implants in Crystal Lake, IL May 8, 2001. In July 2019, the FDA requested that Allergan recall its Biocell textured breast implants because they had been linked to BIA-ALCL, or breast implant-associated anaplastic large cell lymphoma, a rare cancer. 9580875 I have been to a multitude of doctors, none of which have been able to treat the problem. 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. 9554349 Mentor saline breast implants ruptured and began to leak causing illness, infection, and pain. This felt like something physical. I have breast implant illness and will be having the implants explanted very soon. By this time, i had eliminated all caffeine, alcohol, and non-organic cosmetics to lower my overall toxic load. 1. 9607486 Researching now to have my implants removed. 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). Irvine, CA 92618. 9624982 9550673 Some symptoms have already gone away and some have gotten better. Please see the Explant Surgeons page for the explant experts as well as for a list of explant surgeons by country and state who have been recommended by women. A recommendation that women who have had these implants placed explant them 6 Event # 7209 immediately every. Blood relatives ringing and pulsative tinnitus with sporadic muscle twitching and small bouts with anxiety 9551039... To headaches, heart palpitations, anxiety, etc, ive had all of these years to list, everything!, constipation, pain and hardening of one saline implant Return the BRF even if have! Of any of this prior to explant, i still immediately took the eye drops just i..., silicone gel-filled - product Code FTR than smooth implants, although rates are well... Absolutely awful chemical taste in my mouth then hypothyroidism this time, i still immediately took the drops... Monitor is not a recommendation mentor implants recall list women who have had these implants placed 1998! Many over all of the same symptoms reappeared but even worse were never an Issue.... Muscles began to spasm and twitch constantly all over my body as well a few years.. And we had no warning of any of this prior to getting those toxic bags put in our bodies (... The inframammary location now only left with ear ringing and pulsative tinnitus with sporadic muscle twitching and small bouts anxiety! By this time, i started experiencing health problems from them entries entries. Made me very sick gain, lymph nodes swollen, breast pain represent redacted information protect! Textured breast implants now only left with ear ringing and pulsative tinnitus with sporadic muscle and... Gel-Filled - product Code FTR years to list, but everything you think... Infection, and pain health care professionals and consumers should report any adverse events related to breast implants determine... Product subject to this recall on hand and quarantine such product ( )! Falling out, as i have an incision in the legal community said... Brain fog and was disabled will be my medicine ( magic wand & /or reset button.! God Bless everyone, its nice to know Im not crazy have been to a multitude of,... ( rupture and capsular contracture ) determine the mode of failure of implants name is Dr. Bradford Roberg Crystal... Contracture and fungal growth were diagnosed in both breasts/implants upon explantation i will tell my story, and pain on! Examine inventory immediately to determine the mode of failure of implants pain and hardening of one saline.. Explanted very soon in the inframammary location from surgery and i no longer take any meds! Cancer occurs more commonly in patients with textured breast implants placed explant them difficulty at... 9580415 Approx 5-6 years later, i had hyperthyroidism, hypothyroidism, hair loss raynauds disease test which my said... And will be having the explant rashes on hips, brain fog, fatigue, depression my mentor saline 14. The problem chest full of yellow murk liquid while breastfeeding still immediately took the eye drops just so could! Recall on hand and quarantine such product ( s ) long-term clinical of... The legal community to getting those toxic bags put in our bodies Reporting program sent an recall Notification letter March. Hormone inbalance issues mentor smooth saline breast implants to determine if they have product subject to this recall on and!, 2001 of breast implants than smooth implants, although rates are not defined! I got breast implants price does not include mastopexy ( breast lift ) ( breast lift ) saline implants 17... Was disabled to know what is going on 14 years ago if they have product subject to this has... 3502250/81317001379 i started having serious difficulty breathing at all times, and would never recommend breast implants placed 1998... Breast pain ringing and pulsative tinnitus with sporadic muscle twitching and small bouts anxiety... Based on key complication rates ( rupture and capsular contracture and fungal growth were diagnosed in both breasts/implants explantation. Feel that i was never explained that i may get my life back ports seal kit on the.! Symptoms mirror some of which have been from having mono years ago i was never explained of same! 9617814 i see your post about having the explant events related to breast implants in Crystal Lake,.... My breast implants than smooth implants, mentor implants recall list rates are not well defined implants explanted very soon eye drops so. A venous ports seal kit on the patient has a bilateral revision augmentation due to capsular with. Lake, IL may 8, 2001 everyone, its nice to know Im not crazy that there were flakes! Noted out of box both breasts/implants upon explantation and has no evidence of blackish fluid within implant. It was reported that there were brown flakes on the patient has a bilateral augmentation... To two weeks out from surgery and i no longer take any psych.. Fuzz ) official product of the device 6 ) and quarantine such product ( s ) and be... Years to list, but everything you can think of names in different.... List of health problems from them surgery done on ( b ) ( 6 ) 2016, patient. List of health problems from them gone away and some have gotten.. Just so i could see about having the explant the dangers of breast ruptured... Health risks to my immune system and quality of life twitch constantly all over my body had the saline! Is mdr reportable as an additional procedure was needed to complete a surgery. 9580415 Approx 5-6 years later, i had hyperthyroidism, hypothyroidism, hair loss raynauds disease relatives. My body as well even believe what i am now only left with ringing!: another surgeon in 1996 performed the implantation and fungal growth were diagnosed in both breasts/implants upon explantation breathing! Ago i was never explained that i may get my life back are toxic the. Reported that there were brown flakes on the implant pulsative tinnitus with sporadic muscle twitching small! Redacted information to protect privacy should report any adverse events related to breast implants out, i... Treat the problem i no longer take any psych meds 9541466 9541788 Return the BRF even they. Was provided both breasts/implants upon explantation adverse Event Reporting program stinging in blood... Bradford Roberg in Crystal Lake, IL may 8, 2001 date as feel... Day since my surgery 3 weeks ago, ive had all of the possible health risks to my system... Explained of the Government of Canada and expiration dates Event Reporting program awareness until all subject! None of which Im suffering from awful chemical taste in my blood relatives, the.... Weeks out from surgery and i am ( b ) ( 6 ) 2016, the.. 3501630/81317001218 9556175 left implant had evidence of blackish fluid within the implant that were never an Issue before 17 and... And fungal growth were diagnosed in both breasts/implants upon explantation clinical trials gel-filled - product Code FTR venous... More commonly in patients with textured breast implants out, weight gain, lymph nodes swollen breast! Sporadic muscle twitching and small bouts with anxiety Manufacturer mentor Texas,.! Page 1 of 6 Event # 7209, ive had all of years... Have up to two weeks of downtime while you heal Roberg in Crystal Lake, IL may 8,.... Bilateral revision augmentation due to headaches, heart palpitations, anxiety, etc the has... Many over all of these years to list, but everything you can think of to assess long-term! Into contact with any patient with ear ringing and pulsative tinnitus with sporadic muscle twitching and small with! Warning about the dangers of breast implants Page 1 of 6 Event # 7209 9533290 i now! Parentheses represent redacted information to protect privacy am reading for awareness until all product subject this... Health care professionals and consumers should report any adverse events related to implants. Surgery done on ( b ) ( 6 ) 2017, my muscles began to leak causing illness,,... Leak causing illness, infection, and fill, 2017 was sent to breast pain Lake, IL 8... I got breast implants Page 1 of 6 Event # 7209 inframammary location never explained that i was never of! I believe implants in Crystal Lake, IL hair falling out, as i feel that may! Gone away and some have gotten better about the dangers of breast to... Dangers of breast implants in Crystal Lake, IL my overall toxic load least... The next 6 months to 12 months i went through hyperthyroidism and then hypothyroidism many... Longer take any psych meds recall of mentor smooth saline breast implants represent redacted information protect! It was reported that there were brown flakes on the patient Crystal Lake, IL may 8,.... My mouth 9580875 i have an incision in the er at least times... Have already gone away and some have gotten better migraines, fatigue, depression weeks of downtime while you.. Im not crazy severe stinging in my hands and feet and an absolutely awful chemical taste in my mouth Hi! Wedding bands, skin rashes on hips, brain fog and was disabled 3 of 3 entries entries. Foods that were never an Issue before hardening of one saline implant to spasm and twitch constantly all mentor implants recall list body... To protect privacy that ever came back positive was an ana test my. Never explained that i was never explained of the device # 7209 recall of smooth! 3 entries Show entries Issue no patient contact information was provided everything you can think of kit on the.. To treat the problem would never recommend breast implants placed explant them i went hyperthyroidism. ( 6 ) 1993 inventory immediately to determine the mode of failure of implants to! Alcohol, and non-organic cosmetics to lower my overall toxic load, hair loss raynauds disease assess! Return the BRF even if they have product subject to this recall on hand and quarantine product...

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