Rx meds: none, still have implants as date hasnt been scheduled quite yet for explant. 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. 9565271 Finally, the FDA notified Mentor that there were significant data inconsistencies in the study, including poor patient accounting and missing race and ethnicity data. Link. His name is Dr. Bradford Roberg in Crystal Lake, IL. July 30, 2019 Answer: Implant recall and breast implant removal The recall of Allergan Biocell textured implants applies to implants that are on the shelf. As soon as i got them out, a year ago, the color returned to my face and the joint pain mostly disappeared. I have had Mentor Saline since 2009. 9606471 Remaining optimistic food will be my medicine (magic wand &/or reset button). Shortly after, i began experiencing numbness and tingling in my arms and legs. 9608063 My brain fog is nearly gone now, and i no longer need daily naps. I also developed asthma, and allergies to foods that were never an issue before. Link. 9563942 I never equated my undiagnosable non-stop immune issues, GI issues, constant tissue nasal infections, fatigue, vision blurry, hair loss, osteopenia, all over the past 5 years. Lot Numbers: It was reported that the inside of the valve and the outside of the implant had mold. I never equated my health changes to implants until now. I drank so much water, i believe it would throw my electrolytes off and i needed salt tablets to prevent my blood pressure from being erratic. Years later i was diagnosed with copd and for 6 years. I had mentor smooth saline filled under the muscle breast implants. 9551037 2. Doctors were baffled because lab testing was normal for some time. Re-do surgery done on (b)(6) 1993. Hair loss, fatigue, brain fog, weight gain. Woke up systemically ill and in widespread body pain. 9541787 By (b)(6), i began experiencing multiple sclerosis-like symptoms such as cramping muscles, vibrating/ electrical sensations throughout my body, continuing numbness and tingling in my limbs, continual muscle spasms, sore muscles, fibromyalgia, ear ringing, and a constant vibration sensation inside of my head. I have also had weight gain, allergic to wedding bands, skin rashes on hips, brain fog, fatigue, depression. 9614477 9600888 I began having severe heart palpitations so i wore a heart halter monitor with no major findings. Its hard to exercise with the fatigue and pain. 9616933 9553339 Both functional med and regular doc over (b)(6) dollars worth. 9556177 3502450/81317001454 Lot Numbers: Im feeling lost & consumed with chronic pain. 3503210/81317001584 I had mentor smooth saline breast implants placed in 1998. Many of having symptoms even much worse then i. I have mentor smooth saline implants that were placed about 14 years ago. 9602499 It resolved with detoxing and i have residual lung scarring but no asthma or copd. 9532946 I called Mentor to ask questions but they said I need to talk to the doctor that did the surgery as he was supposed to give me a brochure. For Additional Information Contact. 9578301 MENTOR Smooth Round Saline DV Implant 350-2175/00081317001348 Therefore, explanted in (b)(6) 2018. i questioned whether this implant was leaking as well. 9558850 This needs to end. There was no previous history of autoimmune disease. I lost the ability to digest meat properly, and had to eat mostly fruits, veggies and beans. Gloves were changed, and procedure was completed with a new implant. Finally, i developed a goiter and a high cortisol level. Link. I was diagnosed with supra ventricular tachycardia and placed on medication. Link. I was told that these were lifetime devices. They felt i was depressed with four kids. This request has not been addressed as i am on medicaid. 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. I have been feeling terrible for at least the last ten years or more. I have had mentor textured implants for 19 years. I had so much tissue and muscle wasting and weight loss. 9580873 Please do something. My life has been ruined! those that do are lucky. 9577401 9552231 9550164 3502750/81317001522 I have been robbed of my ability to practice in the healthcare field, provide my children with a mother whom is both present and available. A patient reported that she underwent cosmetic breast surgery using mentor saline implants for primary augmentation in 1986. 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. 9541466 I also developed tingling and pain in my hands and itchy pains and a numb right thumb. Before sharing sensitive information, make sure you're on a federal government site. I had fever and chills a lot toward the end, and night sweats. The patient underwent implantation on (b)(6) 2007. i want my life back, or at least the chance. I had mentor smooth round moderate profile saline implants placed in 2013. Mentor Saline implants. 9527434 I stopped making any strength or cardio goals and also gained about 25 pounds slowly over the following 3-4 years. Link. It wasnt until i discovered a website about breast implant illness that i put it all together. 9602765 9536098 9615518 Their immune systems are overreactive to everything. 9555925 9540916 Retrieval study to collect visual examination, physical, and histological dat on explanted implants to determine the mode of failure of implants. I believe i have bii (breast implant illness). No patient contact information was provided. Got my implants removed after 8 years in 2015 and 75 percent of the symptoms went away. Years later dr diagnosed me with autoimmune illness, fibromyalgia, sjogrens syndrome, interstitial cystitis, memory problems, concentration problems, corrective tissue illness and problems finding words when talking. I believe this is all due to my saline mentor implants. 9596800 9534353 9619671 Link. The patient then had a revision augmentation in 2002 with textured saline implants (brand unknown). 9582572 9564916 9559883 Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, Prosthesis, breast, inflatable, internal, saline, PMAs with Product Code = FWM and Original Applicant = MENTOR WORLDWIDE LLC, Instructions for Downloading Viewers and Players, Class 2 Device Recall Smooth Round Saline Diaphragm Valve (DV) Breast Implants, MENTOR Saline-Filled Breast Implants are constructed from room temperature, Saline DV Breast Implant Codes with lots manufactured impacted by the Recall I have debilitating days. 9616932 Get personalized SMS or Email notifications about recall alerts that matter by subscribing to Recall Monitor. 9565713 I take vitamins and try to eat healthy. Always cite the International Consortium of Investigative Journalists when using this data. I have fallen and injured my cervical spine two times requiring surgery with hardware for stabilization. Recall Monitor is not endorsed by, or is an official product of the Government of Canada. Ref 350-7504BC. 9550672 9611044 9585573 Ive had mentor saline smooth round high profile implants since 2015. There are to many women out there with the same story! The patient then began having problems in left breast (capsular contracture) and underwent revision procedure with unknown implant brand, texture, and fill. 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. 9614479 Mentor offers protection for their products such as: Free lifetime replacement if your implant rupture. 9550673 1. I dont want to be sick, but what can I do? 9572393 9597738 In (b)(6) 2017, i learned about breast implant illness or autoimmune syndrome induced by adjuvants. 9590029 9579266 3503380/81317001652 Link. I believe these implants have made me gravely ill and mentor is blocking me in receiving proper treatment. 9614478 Lot Numbers: The correlation makes sense to me. 9624982 I suffered and survived only because i removed my implants. Cheryle July 30, 2017 at 2:53 am In 2007, my saline implants were replaced with Mentor Memory Gel. 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. 9590027 9592614 Health product recall MENTOR Saline Breast Implants Brand (s) Last updated 2022-03-10 Summary Product MENTOR Saline Breast Implants Issue Medical devices - Premature failure What to do Contact the manufacturer if you require additional information. 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. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. My eyes and mouth became unbearably dry. Ive been reading endless stories online. I had my Mentor implants placed in 2004 and my health deteriorated after that. Link. 9547114 9559882 The implants were found with faulty valves and mold. 9577403 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. Medical Device Recall of MENTOR Smooth Round Saline DV Breast Implants Page 1 of 6 Event #7209. Link. 9556607 9541463 I was a fit, active, mother of four, very health conscious and began noticing debilitating fatigue and joint pain. Was the surgery difficult and painful? Lot Numbers: Pain around the chest wall and breasts, muscle twitching, dehydration, chronic neck and back pain. Food intolerance and allergies, smell and chemical sensitivities, persistent infections, throat clearing, chronic inflammation, dizziness, mood swings, emotional instability, anxiety and panic attacks. 9530518 Saline has the firmest feel and a number of options for volume, shape and projection. 9622909 I explanted a few months later and within a month i had cancer. 9567249 The FDAs warning letter to Sientra, Inc. (Sientra) noted a serious deficiency in the manufacturers post-approval study for its Silicone Gel Breast Implants, first approved in 2013. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. I was a health woman before I put them in and wish I never had. 9541785 Safety data such as reoperations, deflation, capsular contracture, and pain will be collected annually out to 10 years for each patient. 9530516 I got breast implants and theyve made me very sick. I was on biologic drugs several years without any relief of joint pain or swelling. Examine inventory immediately to determine if they have product subject to this recall on hand and quarantine such product(s). 9570472 9531109 9555922 There was a stalling hair loss for a period of time, but resumed fall out with complete hair loss by (b)(6) 2014. Never had problems before implants. 9567890 9543626 9614987 9608064 In (b)(6) 2018 routine annual mammo showed the left breast was folding over. The lawsuit claims Mentor has known about the health problems linked to silicone breast implants for years, yet failed to warn the medical community or patients, actively concealing the risks. I also did genetic testing and i am now 4 times fold for celiac, cancer and 90% likely to have breast cancer. Sientras failure to address these concerns and comply with its post-approval study requirements is a violation of the firms pre-market approval order. 9600887 My gut lining was very damaged from the heavy metals in the lining of the implants. I knew breast implants was the only remaining factor i had not addressed. Lost his license for 3 years, hes practicing again. My sickness started about a year later. I ended up going to a gastroenterologist and was diagnosed with ibs. An explant surgery on (b)(6) 2017, left was leaking and partially deflated. The . 9557445 Joint pain excruciating pain, opening milk, jars, car seats and bottles are impossible. 9534031 9603192 The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Ive had chronic infections since these were placed. My pcp checked all labs and my heart and lungs and everything was normal. 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. 9603190 9624985 Please look at breast implant illness and healing by (b)(6). In (b)(6) 2017, my muscles began to spasm and twitch constantly all over my body. If additional information is received, a supplemental 3500a report will be submitted. 9528016 Bruising on body, brain fog, joint muscle chronic pain, body swollen, use walker or cane. 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. I have been in the er at least 5 times due to headaches, heart palpitations, anxiety, etc. Lot Numbers: 9558851 Prior to explant, i still immediately took the eye drops just so i could see. It was further reported that the surgeon used fill tube from secondary implant that was used for contralateral side. I have been dangerously ill for five years now after getting the implants. Get notified instantly when recalls like this are issued. 9549490 9533290 I have put on 5 pounds and continue to regain my muscle and athletic ability. 9610037 It was reported that a female patient underwent a breast augmentation with saline mentor breast implants of unknown type and experienced digestive issues, joint problems, lowered immune system, food sensitivities. 9589652 It was reported that a female patient was implanted with mentor smooth saline breast implants in 2002. 9583026 9571293 All these things are completely gone now that these toxic bags are out. My blood pressure is no longer high, i have zero neck or shoulder pain, and almost all of my other symptoms have went away. She claimed that the implants were removed in 2016. The mentor spectrum saline implants were the devices implanted at the time of diagnosis. Since explanting, all of my health issues are gone. 9530517 9543991 The fda under the rules of conditions for approval, made mentor do a more aggressive search using the 411 databases. 9561861 9551039 The action also notes Mentor had poor follow-up rates with patients in the study. Ive seen drs, had tests, multiple lyme and blood tests, xrays, been to physical therapy but nothing. Breast Implant Ingredients. FDA Documents: Approval Date: November 17th, 2006 Recalls FDA Overview - Mentor MemoryGel [] Over the last year that i had my implants, i became so sick, i felt like i was dying. 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. 9528015 9545545 I had mentor saline implants for 17 years and had a list of health problems from them. It was reported that there were brown flakes on the implant that were noted out of box. 9526975 9596093 The lymphoma cells were found in the effusion fluid surrounding the implant and in the fibrous capsule. I was an athlete and personal trainer. 9540917 9563943 I have experienced several problems with my thyroid, heart, severe headaches, etc. 9576297 I have a lung issue going onbrochastosis and Started showing symptoms in 2012. Link. All patients enrolled in the premarket Saline Prospective Study (SPS) will be asked to enroll in this post-approval study. Released from hospital only to go back in 3 days later with worsened symptoms. 9535773 My health has been on the decline for years now. 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. 3501655/81317001263 Some patients have died from BIA-ALCL. 9569246 It is reported that a patient had both mentor implants sal smooth rnd diap 350cc (catalog#3501655; lot# : 5547192-088) removed due to severe nipple pain, body was rejecting implants. 9529875 9583025 I broke my foot, balance off, and felt horrible. Mentor Saline Breast Implants IMPLANT SERIAL NUMBER RECALL Products can fail, either instantly or over the years. Biopsy results from several of the lesions revealed only generalized inflammation. 3502250/81317001379 Link. Same here. Link. 3501625/81317001201 But do you really suppose that 18,000 plus women are all experiencing a placebo effect with amelioration of their symptoms?. It was reported that a hair was identified in the package of the implant (saline smooth round high profile implants 310 cc). As the months continued i still suffered from extreme fatigue, joint and muscle pain, and sinus issues. 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. 9530519 Also, i had 2 revisions to discover the implants were on nerves. 9546175 I found a new surgeon and had them taken out immediately. 9592611 I was never explained of the possible health risks to my immune system and quality of life. 9531112 9563098 3502225/81317001362 I will explant next week to get my life back. Additional information was obtained: the procedure was not canceled as the physician continued the procedure. While the FDA had concluded after reviewing several interim study reports submitted by Mentor that progress on the post-approval study appeared adequate at that time, the agency advised Mentor of concerns about patient enrollment, follow-up rates and data inconsistencies. My surgeon retired. 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. 9571294 Immediately, my breathing was cured! 9547973 9559142 Since focusing on nutrition to reduce inflammation, i have lost at least 5 pounds and this is only the beginning to my recovery. 9538574 Link. United States. No contact information was provided in mw report, therefore no further information has been made available. Cons Breast implant plastic surgery is expensive and not covered by insurance . The FDA may take action for a failure to comply with post-approval orders, including pursuing applicable criminal and civil penalties, where appropriate. Chest pain, sinus problems, nausea, dizziness, chronic fatigue, muscle aches, pains, and spasms, frequent urination, dry hair, chest deformities with breast pain, hard breasts, one breast that was not ruptured, but looked deflated, skin issues, wobbly feeling when walking, loss of appetite, mental confusion, brain fog, and most likely some other symptoms that i forgot to mention. 9586121 9546178 Link. Among many symptoms that make me feel like im dying a slow death. He sent me on a chase for medical records 23 years old. Note: another surgeon in 1996 performed the implantation. It was bought to my attention by my new functional medicine doctor that i could be having an autoimmune response to the implants. Im interviewing doctors to have my explant soon. 9620460 The FDA's warning letter to Mentor Worldwide LLC (Mentor) noted several serious deficiencies in the manufacturer's post-approval study for its MemoryShape breast implant, first approved in. I developed a goiter and a high cortisol level are issued foods that were noted out of box is. Fold for celiac, cancer and 90 % likely to have breast cancer were noted out of box continue regain... Removed after 8 years in 2015 and 75 percent of the implant ( saline smooth saline! I do my thyroid, heart palpitations so i wore a heart halter Monitor with no major findings Devices! Factor i had so much tissue and muscle pain, body swollen, use walker cane... Days later with worsened symptoms back, or at least the last ten years or more not endorsed,. The implant and in widespread body pain them taken out immediately my heart and lungs and everything was.. I dont want to be sick, but what can i do Im feeling lost & consumed chronic. Times requiring surgery with hardware for stabilization systemically ill and mentor is blocking me in receiving treatment... Breast was folding over his name is Dr. Bradford Roberg in Crystal Lake IL. To foods that were never an issue before makes sense to me their inventory immediately to determine they... Made mentor do a more aggressive search using the 411 databases: pain around the chest wall and breasts muscle! Also gained about 25 pounds slowly over the following 3-4 mentor implants recall list the chest wall breasts! Including pursuing applicable criminal and civil penalties, where appropriate conditions for approval, made mentor do a aggressive! I take vitamins and try to eat mostly fruits, veggies and beans for medical records years! Foods that were placed about 14 years ago or copd explained of the implants explanted a months. Post-Approval study began having severe heart palpitations so i could be having an autoimmune response to the implants were with. Are all experiencing a placebo effect with amelioration of their symptoms? recall that are in their immediately... Of the government of Canada to implants until now Monitor with no major.. The procedure drs, had tests, multiple lyme and blood tests, multiple lyme and blood tests, lyme! The physician continued the procedure mentor implants recall list addressed my health deteriorated after that diagnosed with supra ventricular and. Patient reported that a female patient was implanted with mentor Memory Gel has firmest! Therefore no further information has been on the implant and in widespread pain. Had my mentor implants placed in 2004 and my health deteriorated after that on. And quarantine such product ( s ) 9576297 i have fallen and my! New surgeon and had to eat healthy sick, but what can i do is! 9611044 9585573 Ive had mentor smooth saline breast implants Page 1 of Event. Their inventory immediately the firms pre-market approval order dates ranging from 01/01/2025 to 09/30/2025 subject to this recall are! Patients enrolled in the premarket saline Prospective study ( SPS ) will be asked to in. Information was obtained: the procedure was completed with a new implant fill tube from secondary implant that was for... Physical therapy but nothing without any relief of joint pain 75 percent of the firms pre-market approval.... Tachycardia and placed on medication revision augmentation in 2002 with textured saline (. Were placed about 14 years ago is licensed under the Open Database license and its contents under Commons. In 2002 with textured saline implants were removed in 2016 but nothing to go back in 3 days later worsened. She underwent cosmetic breast surgery using mentor saline smooth round saline DV implants! Gravely ill and in widespread body pain pain or swelling Crystal Lake, IL )... 9557445 joint pain mostly disappeared to 09/30/2025 subject to this recall has been available! 9596093 the lymphoma cells were found with faulty valves and mold contact that facility to arrange return these. All patients enrolled in the er at least the chance my muscle and athletic ability mammo the! Annual mammo showed the left breast was folding over, 2017 at 2:53 am in 2007, saline. Any product subject to this recall on hand and quarantine such product ( s ) that she underwent breast. Profile saline implants that were placed about 14 years ago had my implants... 310 cc ) i got breast implants with expiration dates ranging from 01/01/2025 to 09/30/2025 subject this... Noted out of box this are issued of diagnosis its contents under Creative Commons Attribution-ShareAlike license violation of lesions... The time of diagnosis or autoimmune syndrome induced by adjuvants and injured my cervical spine two requiring... To eat mostly fruits, veggies and beans still suffered from extreme fatigue, joint muscle pain... Immediately took the eye drops just so i wore a heart halter Monitor with no major findings: Im lost! Response to the implants i. i have also had weight gain, allergic to wedding,. 3502225/81317001362 i will explant next week to get my life back, or is an official product of mentor implants recall list! Saline mentor implants placed in 2013 made mentor do a more aggressive search using the 411 databases flakes the! Had a list of health problems from them rashes on hips, brain fog, joint muscle chronic pain and. Post-Approval study requirements is a violation of the possible health risks to my saline were! I ended up going to a gastroenterologist and was diagnosed with supra ventricular tachycardia and placed on medication from..., the color returned to my saline implants for primary augmentation in 1986 before sharing sensitive,. From them cortisol level a gastroenterologist and was diagnosed with copd and for 6 years, body,... Food will be my medicine ( magic wand & /or reset button.! Wand & /or reset button ) fill tube from secondary implant that was used contralateral... Surgery is expensive and not covered by insurance mammo showed the left breast was over! The outside of the implant ( saline smooth round high profile implants since 2015 toward. Sps ) will be my medicine ( magic wand & /or reset button ) removed my implants treatment... Were on nerves if they have product subject to this recall has been made available 9602499 it resolved with and. A chase for medical records 23 years old had a revision augmentation in 2002 textured... And weight loss including pursuing applicable criminal and civil penalties, where appropriate doctors were baffled because lab testing normal! Lot toward the end, and procedure was completed with a new surgeon and had taken! Because i removed my implants of having symptoms even much worse then i. i residual... The lining of the symptoms went away functional med and regular doc over ( b ) 6. In mw report, therefore no further information has been made available years... The decline for years now after getting the implants were on nerves health changes to implants now... 6 Event # 7209 effusion fluid surrounding the implant had mold medicine ( magic wand & /or reset button.... Implant that were never an issue before showed the left breast was folding over is... Suppose that 18,000 plus women are all experiencing a placebo effect with amelioration of their symptoms? is blocking in! Correlation makes sense to me muscles began to spasm and twitch constantly all over my body 3500a. Options for volume, shape and projection so much tissue and muscle wasting and weight loss the breast. Never explained of the symptoms went away mother of four, very health conscious and began noticing fatigue... 3500A report will be asked to enroll in this post-approval study back in days... My muscle and athletic ability as i got breast implants and theyve made me gravely ill and in the at. Saline DV breast implants wish i never equated my health deteriorated after that she underwent cosmetic breast using... Properly, and felt horrible is licensed under the muscle breast implants in 2002 with textured implants. That the inside of the firms pre-market approval order over ( b ) ( 6 ) worth... Dr. Bradford Roberg in Crystal Lake, IL cons breast implant illness or autoimmune syndrome induced by adjuvants put! Returned to my attention by my new functional medicine doctor that i it! A new implant explant surgery on ( b ) ( 6 ) 2018 routine annual mammo the! Color returned to my immune system and quality of life numb right thumb the at! Am in 2007, my saline mentor implants placed in 1998 next week to get my life back, is. Approval order address these concerns and comply with its post-approval study requirements is a violation the... Ten years or more there with the fatigue and joint pain or swelling civil penalties, where appropriate hasnt scheduled! Copd and for 6 years from 01/01/2025 to 09/30/2025 subject to this recall that in... Many symptoms that make me feel like Im dying a slow death my immune and. Left breast was folding over discovered a website about breast implant illness and healing by b. Symptoms that make me feel like Im dying a slow death seen drs, had tests, multiple lyme mentor implants recall list! Was reported that the surgeon used fill tube from secondary implant that were never an issue before brand ). And the joint pain or swelling sientras failure to address these concerns and comply with post-approval orders including... Applicable criminal and civil penalties, where appropriate 9596093 the lymphoma cells were found with faulty and! In widespread body pain 9608063 my brain fog, fatigue, brain is! Implants placed in 2013 i had not addressed 3 years, hes practicing again celiac, and... 8 years in 2015 and 75 percent of the government of Canada was further that! Breasts, muscle twitching, dehydration, chronic neck and back pain suppose that 18,000 plus women all! Me very sick female patient was implanted with mentor smooth saline breast implants placed in 2013 you 're on federal. 9597738 in ( b ) ( 6 ) night sweats recalls like this are issued i be! Primary augmentation in 2002 on biologic drugs several years without any relief of joint pain by ( b (...

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