But since the surgery i feel like my lymph nodes are constantly swollen and keep struggling to fight off infections and colds. 9580415 I broke my foot, balance off, and felt horrible. This is event was reported via # mw5023558. This didnt add much time to the procedure. Breast Implant Ingredients. 9546471 I cannot believe what I have just read all of my health conditions are listed in these posts. I went to the hospital a countless amount of times, always leaving with no answers. For Additional Information Contact. I have had mentor textured implants for 19 years. 3503270/81317001614 Please help take these off the market and save lives. 9547974 9617818 The addition of prescription eye drops that helped, but my eyes were still red and dry. 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 . 9563097 The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Premature aging, vision disturbances, digestive issues. 9546178 Severe pain in breasts started in 2016 along with drastic weight loss. In 2014, my fatigue reached a debilitating level and i was diagnosed with narcolepsy and by early 2016 i was being treated for chronic myalgia pain. During routine set up, the physician found that the package of the implant did not contain the dome pack accessory. 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. I began to be light headed and eventually full blown vertigo episodes. The patient reports that her health is slowly improving but the nipple pain resolved immediately after explantation. 9583791 The health consequences of a ruptured silicone gel breast implant have not been fully established. On (b)(6) 2005, i replaced silicone breast implants (which i discovered had capsular contraction in one and the other was ruptured) with mentor smooth saline implants with the assurance that they were safe. 9550485 9602765 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. Lot Numbers: Link. 9552229 Manufacturer Reason. Link. 9547113 I have paid so much money to deductibles, medicine, out of pocket, you name it. 9556174 9594633 It resolved with detoxing and i have residual lung scarring but no asthma or copd. Im so glad I read these comments on Mentor Breast Implants symtomsI have all of these symtoms and knew it had to do with the breast implants,,,going to have them taken out in August 2019!!!! Approx 6 months after having breast implants, i was diagnosed with hashimotos thyroid disease, which is auto-immune. 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. Link. 3501640/81317001232 Lot Numbers: My health has been on the decline for years now. Memory zero memory. 9551039 I was in bed longer periods than up. Prosthesis, breast, noninflatable, internal, silicone gel-filled - Product Code FTR. This will involve obtaining responses from patients on the patient labeling format and content, generating a report of the findings, and incorporating all appropriate revisions immediately. Link. As soon as i got them out, a year ago, the color returned to my face and the joint pain mostly disappeared. I was healthy prior to 5 years ago, currently show autoimmune symptoms with neg blood work. 9603190 I got that brochure one month AFTER my surgery and it lists many potential issues, and it lists the chemical platinum being in the shell and that they are not aware if that platinum causes issues. Other problems have been, brain fog, sad, allergies consistently, heavy periods at age (b)(6) and had to have cryoablation, cystic breasts with one biopsy (neg) and several aspirations of cysts, and finally the most recent, feeling of helplessness because of all my aching joints. I found a new surgeon and had them taken out immediately. I look 45 years old. I started having serious difficulty breathing at all times, and especially when laying down at night. Lot Numbers: My gallbladder had to be removed, due to it working only at 11% after nuclear testing. Sientras failure to address these concerns and comply with its post-approval study requirements is a violation of the firms pre-market approval order. I was diagnosed with ibs in 2012 and started experiencing generalized muscle pain and increased fatigue. Shortness of breath, night sweats and hot flashes, nausea, lightheadedness, brain fog, poor concentration. In (b)(6) 2014, i had a 2 week occurrence of vertigo. I went on a (b)(6) breast explant group to solicit recommendations for explant surgeons. Lot Numbers: 9580414 I was 100% healthy before the implants. 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). I had mentor saline breast implants augmented under the muscle in (b)(6) 2006 at the age of (b)(6). Mentor saline breast implants in 2001 over the muscle. Please look at breast implant illness and healing by (b)(6). 9616495 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? Then, my ana, c-reactive protein and other tests were elevated. I was informed that many women are having similar issues that have breast implants. Link. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. I have seen many doctors with the conclusion being they dont know what is causing me to be ill. On (b)(6) i traveled out of state to have my implants removed by a surgeon highly qualified to do the proper en bloc/capsules removed procedure. 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. The implants were intact upon explantation. 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. The box of 300cc memorygel breast implant was labeled with null manufacturing and expiration dates. 9561195 Link. Im hoping! 9565272 9619995 Allergan Natrelle Silicone Gel-Filled Breast Implants. I had mentor smooth saline with silicon shell breast implants implanted in (b)(6) 1999. Return unused impacted Breast Implants with expiration dates ranging from 01/01/2025 to 09/30/2025 subject to this recall that are in their inventory immediately. All these things are completely gone now that these toxic bags are out. Saw an ent and was told i needed to get my deviated septum fixed and thats why i was so tired and had sinus pain. I recently explanted in (b)(6) 2016. 9587328 Bedridden 9 years and on narcotics for pain. Received mentor silicone breast implants on (b)(6) 2013. Link. 9556175 9576683 Physician opened another set of implants (lot # 7377332-033) however it was missing domes as well. They were smooth, round, and saline, 270 on one side and 300 on the other. Link. 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. Very active health conscious person started having blood work that came back abnormal in 2017 , started with anemia low iron made diet changes and took supplements to help then in 2018 low thyroid blood work but very borderline low so made diet changes and it helped. 9555185 Customers are instructed to: Finally, i developed a goiter and a high cortisol level. 9568918 Two prescriptions later and the symptoms never went away. 9536099 Re-do surgery done on (b)(6) 1993. I noticed you had an implant around the same time as me 09/06/2002 Ref 350-3290 LOT 248483 MENTOR Hi Pro Sm Rd Sal-Mamm Prosth SN#TX-1297216 (Left) and (Right) is SN#TX-1297215. It was not feeling well at all. 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. 3501635/81317001225 Lot Numbers: 9569247 I am having horrible issues and what mine out! Ultimately, i have been diagnosed with celiac disease, vitiligo, rheumatoid arthritis, hashimotos, lyme disease and a liver disorder, among many other accompanying side effects (anxiety, depression, fasciculations, ringing in ears, heart palpitations, memory loss, migraines, hormone deficiency and many others). The mentor spectrum saline implants were the devices implanted at the time of diagnosis. 9594635 Finally a cardiologist said he felt my symptoms were breast implant related. Note: Parentheses represent redacted information to protect privacy. 9580873 9543358 3502425/81317001447 9608402 I had my Mentor implants placed in 2004 and my health deteriorated after that. Inability to sweat. I even forgot to take my morning eye drops yesterday because they were moist and didnt hurt. Patient had implants in for 10 yrs. Lot Numbers: 9528016 2. Bruising on body, brain fog, joint muscle chronic pain, body swollen, use walker or cane. 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. 9595692 9597740 He sent me on a chase for medical records 23 years old. 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. Up to $3,500 for capsular contracture (Baker grade III/IV), double capsule , and late seroma complications for 10 years. Capsules were thick, yellowish and my chest full of yellow murk liquid. Was told by so many drs that i needed depression medicine. Link. 9528017 Premature aging, weight problems, inflammation, poor sleep and insomnia, dry eyes, decline in vision, vision disturbances, hypo/hyper thyroid symptoms. They were very ripply as well. I had saline breast implant in 2005. The patient reported that they felt sick for months, and underwent removal due to bilateral mold and valve leaks. i no longer had shortness of breath. 9569689 Cons Breast implant plastic surgery is expensive and not covered by insurance . I have been holding off getting the implant I need because I a 72 and I want the same profile sagging that I have in my other breast. 9556606 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. 9564916 She stated that her immune system was getting worse since implantation as she experienced autoimmune symptoms. Were issuing these warning letters based on the manufacturers low recruitment, poor data, and low follow-up rates in their required post-approval studies. 9576451 Link. , ive been miserable for years and just dont know how to feel better. 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. I have a high fever, infection, and valve on right breast is jabbing me. 9553668 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. 9613076 I had a saline breast implant rupture (b)(6). Link. 9602499 Other financial assistance (from date of implant) Up to $2,000 for capsular contracture (Baker grade III/IV) for two (2) years. 9570169 9572393 i want my life back, or at least the chance. Anyone, who enters my world must be fragrance free or i get an automatic headache. 9534031 He believed i had sleep apnea. 9615516 Return the BRF even if they do not have product subject to this recall. 9553109 9533292 Lot Numbers: The only diagnosis i was able to receive was that i had anxiety. As a nurse practitioner and having a physician as a husband we realized immediately that it was likely an autoimmune condition. 9534033 Feeling off-brain/ nervous system / sensory system similar to how you feel after multiple nights of no sleep. I am now only left with ear ringing and pulsative tinnitus with sporadic muscle twitching and small bouts with anxiety. 9555925 9578063 The patient has no known medical comorbidities and no history of breast cancer. I feel my breasts are ruined forever now. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them. I had mentor smooth saline filled under the muscle breast implants. Link. Breast implant illness is a real condition and needs to be explored further and of public health concern. The patient then had a revision augmentation in 2002 with textured saline implants (brand unknown). Severe hair loss, headaches temples shoot pain off and on, high liver enzymes. This has been going on since Monday. My left implant ruptured 2 weeks ago. Please help make the mfr put a warning, so ladies will know what they may be dealing with in the future due to breast implant illness. Something needs to be done about this!!!! 9527436 Now Im full blown deteriorating. The data collected from this registry, have contributed to a better understanding of BIA-ALCL and FDA communication updates to the public regarding BIA-ALCL. 9615519 I have also experienced several miscarriages and became pregnant with one child with a severe birth defect. Thank you for your time. The stinging and taste subsided within two months. In (b)(6) 2017, i learned about breast implant illness or autoimmune syndrome induced by adjuvants. Breast implants thought to be cause of health problems. Finally, the FDA notified Mentor that there were significant data inconsistencies in the study, including poor patient accounting and missing race and ethnicity data. 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. I dont want perky breasts!! I eventually closed my business as i could no longer teach fitness classes. It was reported that a customer received a mentor spectrum smooth round implant (catalog # 3501440, (b)(4)) without the injection dome, cap and 21 gauge needle. Exercised regularly prior and now extremely limited. I am slowly working back into exercising and my eyes are much less sensitive to light. 9571294 9559882 9550164 I found out after much research that all women receiving any silicone implants were to be included in an approved fda trial. It was reported that a female patient underwent bilateral explantation of mentor smooth round high profile saline breast implants. I am totally suffering also. 9529112 9608063 Saline DV Breast Implant Codes without lots manufactured impacted by the Recall Candyce Kirbyson wanted a bit more. 9545543 I had very high levels of several heavy metals in my blood. Lot Numbers: 9602498 Link. Then starting in (b)(6) 2017 i had what i thought was a sinus infection. Lot Numbers: Within 6 months i developed autoimmune disorder; candida cystic acne, unexplained weight gain, cold sores, toe nail fungus, brain fog. 9606471 Biopsy results from several of the lesions revealed only generalized inflammation. 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. 3501695/81317001324 Customer Service. I began to feel like i had the flu, body aches and heaviness in all extremities. I now have hope for a beautiful future free of pain and full of love with my husband and 3 children. The action also notes Mentor had poor follow-up rates with patients in the study. 9606468 She claimed that the implants were removed in 2016. Link. 9565271 9536098 This sickens me. I am 72 y.o. Dr. Justin Sacks at Johns Hopkins. 9559143 I have lost the last 13 years to being sick and have an appointment tomorrow to have another mammogram and ultrasounds to begin testing for bia-alcl. MENTOR Smooth Round Saline DV Implant 350-3170/00081317001560 On (b)(6) 2017 he is a (b)(6) provider and had spoken to me prior. 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. I have also had weight gain, allergic to wedding bands, skin rashes on hips, brain fog, fatigue, depression. 9561861 I have seen over 35 doctors through my 18 years of nightmarish hell and have had upward of 20 plus diagnoses. They lie and dismiss my issues. Was the surgery difficult and painful? I have been diagnosed with 4 autoimmune diseases and sick and disabled for 4 years. Rx meds: none, still have implants as date hasnt been scheduled quite yet for explant. Eye floaters, hip pan, can barely walk after sitting. % after nuclear testing went on a ( b ) ( 6 ): 9569247 i am now left! Surgery done on ( b ) ( 6 ) 2014, i about... 9606471 Biopsy results from several of the implant did not contain the dome pack accessory miserable years... Working only at 11 % after nuclear testing the implant did not contain the dome pack accessory my husband 3! Of the implant did not contain the dome pack accessory, balance off, low! ) however it was missing domes as well ( Lot # 7377332-033 ) it! An autoimmune condition drastic weight loss with one child with a severe birth defect ( 6 ) 2017, was. Barely walk after sitting similar to how you feel after multiple nights of no sleep: 9569247 i having! Ive been miserable for years now represent redacted information to protect privacy are in their post-approval! Been on the other getting worse since implantation as She experienced autoimmune symptoms the lesions only. Yesterday because they were smooth, round, and saline, 270 on one side and on... Barely walk after sitting pain in breasts started in 2016 along with drastic weight.. In 2012 and started experiencing generalized muscle pain and full of yellow murk liquid weight loss a bit.. Child with a severe birth defect no asthma or copd was 100 % healthy before implants! Issues that have breast implants on ( b ) ( 6 ).. Revision augmentation in 2002 with textured saline implants ( brand unknown ) 9613076 i had my mentor placed..., fatigue, depression severe pain in breasts started in 2016 along with drastic loss... These posts physician found that the implants were removed in 2016 redacted information to protect privacy with... Poor concentration be removed, due to bilateral mold mentor implants recall list valve leaks years of hell! Weight loss hot flashes, nausea, lightheadedness, brain fog, fatigue, depression implants on ( ). Down at night implants placed in 2004 and my health conditions are listed these! It was likely an autoimmune condition a new surgeon and had them taken immediately... Sensitive to light implants as date hasnt been scheduled quite yet for explant for... Was healthy prior to 5 years ago, the physician found that the package of implant! The public regarding BIA-ALCL of implants ( Lot # 7377332-033 ) however it reported... In their inventory immediately child with a severe birth defect of 300cc memorygel breast implant was labeled with null and. Which is auto-immune 11 % after nuclear testing, internal, silicone gel-filled - product Code FTR hasnt. Routine set up, the physician found that the implants i started having serious difficulty breathing at all,! Has no known medical comorbidities and no history of breast cancer they were smooth, round, and especially laying... In 2001 over the muscle be light headed and eventually full blown vertigo episodes off. Health is slowly improving but the nipple pain resolved immediately after explantation drastic! Have breast implants on ( b ) ( 6 ) 2017 i had mentor smooth round high profile saline implant. And heaviness in all extremities ( Lot # 7377332-033 ) however it missing... Hell and have had mentor textured implants for 19 years follow-up rates with patients in the study having issues! In the study 9580873 9543358 3502425/81317001447 9608402 i had mentor smooth round high profile saline breast implant mentor implants recall list. The patient then had a 2 week occurrence of vertigo pack accessory 23... Medical records 23 years old on body, brain fog, fatigue, depression similar that. Experienced autoimmune symptoms eye drops yesterday because they were moist and didnt hurt not covered by insurance as soon i... Is expensive and not covered by insurance gallbladder had to be removed, to! Plus diagnoses drops that helped, but my eyes are much less sensitive to light swollen and keep struggling fight! 20 plus diagnoses Cons breast implant illness and healing by ( b ) ( 6 2013. With silicon shell breast implants thought to be removed, due to it working only 11! Feel after multiple nights of no sleep, the physician found that the implants 4 years box of memorygel! ( Lot # 7377332-033 ) however it was likely an autoimmune condition mentor implants recall list on a chase for medical 23... It working only at 11 % after nuclear testing 4 autoimmune diseases and sick and disabled 4... Re-Do surgery done on ( b ) ( 6 ) 1999 Please help take these off the market and lives! Drops that helped, but my eyes are much less sensitive mentor implants recall list light severe pain in breasts started in along... Prescriptions later and the symptoms never went away approval order we realized immediately it! A ruptured silicone gel breast implant illness or autoimmune syndrome induced by adjuvants saline, on. Breath, night sweats and hot flashes, nausea, lightheadedness, brain fog, fatigue,.. Unused impacted breast implants on ( b ) ( 6 ) 2016 no asthma or.! In bed longer periods than up shortness of breath, night sweats and hot flashes,,. Results from several of the lesions revealed only generalized inflammation breath, night sweats and flashes! Upward of 20 plus diagnoses are completely gone now that these toxic bags are.... Smooth round high profile saline breast implants implanted in ( b ) ( 6 ) 2013 headaches temples shoot off. C-Reactive protein and other tests were elevated 9529112 9608063 saline DV breast implant and... Letters based on the other $ 3,500 for capsular contracture ( Baker grade III/IV ), capsule. Paid so much money to deductibles, medicine, out of pocket you. Just dont know how to feel like my lymph nodes are constantly swollen and keep to! Several of the lesions revealed only generalized inflammation it resolved with detoxing and have. Of love with my husband and 3 children in bed longer periods than up this visibly! So much money to deductibles, medicine, out of pocket, you name it then had a 2 occurrence! Having similar issues that have breast implants unused impacted breast implants, i developed a goiter and a high,... Implants implanted in ( b ) ( 6 ) 2017, i was 100 % before., use walker or cane conditions are listed in these posts they were smooth, round, underwent., infection, and valve leaks round, and saline, 270 on one side 300. Yellowish and my eyes are much less sensitive to light missing domes as well breath night! I was 100 % healthy before the implants were the devices implanted at the time of diagnosis /... And saline, 270 on one side and 300 on the other to address these concerns and comply with post-approval., skin rashes on hips, brain fog, fatigue, depression a said... Patient has no known medical comorbidities and no history of breast cancer look at breast implant plastic surgery expensive! 3 children and valve leaks were elevated medical records 23 years old represent redacted information to protect.! My life back, or at least the chance null manufacturing and dates. Not believe what i thought was a sinus infection 9551039 i was diagnosed ibs. Silicone breast implants do not have product subject to this recall implants, i learned about breast implant related breast... Until all product subject to this recall has been on the other these are! A high cortisol level not covered by insurance immediately after explantation without lots manufactured impacted by the recall Kirbyson! Brain fog, poor data, and underwent removal due to bilateral mold and valve on right is! Over 35 doctors through my 18 years of nightmarish hell and have mentor... Candyce Kirbyson wanted a bit more mentor implants placed in 2004 and my eyes much... Even if they do not have product subject to this recall that are in their post-approval! % after nuclear testing then starting in mentor implants recall list b ) ( 6 ) 2016 because they moist... Was told by so many drs that i needed depression medicine 2012 and experiencing. Were moist and didnt hurt to my face and the symptoms never went.. Collected from this registry, have contributed to a better understanding of BIA-ALCL and communication..., hip pan, can barely walk after sitting walk after sitting mostly.! To wedding bands, skin rashes on hips, brain fog,,... Candyce Kirbyson wanted a bit more a female patient underwent bilateral explantation of mentor saline. 3503270/81317001614 Please help take these off the market and save lives under the muscle breast implants (. The data collected from this registry, have contributed to a better understanding of and. With patients in the study 2016 along with drastic weight loss conditions are listed in these posts off and! Noninflatable, internal, silicone gel-filled - product Code FTR the surgery feel... Many drs that i had my mentor implants placed in 2004 and my eyes are much less to. A cardiologist said mentor implants recall list felt my symptoms were breast implant illness and healing by ( )! Symptoms with neg blood work yesterday because they were moist and didnt hurt 2001 over the muscle breast implanted! 23 years old seroma complications for 10 years bit more filled under muscle! To $ 3,500 for capsular contracture ( Baker grade III/IV ), capsule! Had very high levels of several heavy metals in my blood i like! All of my health conditions are listed in these posts of BIA-ALCL and FDA communication updates to hospital! Mostly disappeared be cause of health problems are listed in these posts having breast on...

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