mentor implants recall list
In (b)(6) 2018, i came across a website about breast implant illness. Lot Numbers: 9558851 I couldnt pick a date as i have been sick from my mentor saline implants since 2014. The customer requested that no further contact be initiated by mentor for more information. 9617820 Mentor saline breast implants in 2001 over the muscle. its an infection. I should not be sick like i am. 9610034 9578300 I found great difficulty concentrating and working fast as i became easily fatigued, but was still working. 9552231 At this point, though, i really just want to feel healthy again and get these toxic bags out!. No additional procedure was required, and no adverse event resulted from this incident. 3501660/81317001270 9531108 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. I started to experience a change in right breast? 9567250 My surgeon passed suddenly in 2003. I have fallen and injured my cervical spine two times requiring surgery with hardware for stabilization. Explanted (b)(6). 9565271 Link. 9610033 my first ones were removed via the area incision and now i have an incision in the inframammary location. I have been to a multitude of doctors, none of which have been able to treat the problem. Implanted with mentor textured implants in 1996. I was depressed, no one knew what was wrong. So much pain and terribly weird sensations, sensitivities and i was only (b)(6). MENTOR Smooth Round Saline DV Implant 350-2175/00081317001348 My primary care physician cannot come up with any findings related to my overall health except that the fact my body is being compromised by breast implants that were deemed safe. I had them removed (b)(6) 2017 and have experienced major healing. The same device may have different names in different countries. Rashes and sensitivities to any lotions, perfumes. I was diagnosed with ibs in 2012 and started experiencing generalized muscle pain and increased fatigue. In 15 months, i saw 6 different drs and had multiple blood tests done. 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. Link. 9555187 But since the surgery i feel like my lymph nodes are constantly swollen and keep struggling to fight off infections and colds. Blurred vision and overall exhaustion. Bruising on body, brain fog, joint muscle chronic pain, body swollen, use walker or cane. Had my surgery in (b)(6). My body ached on a daily basis. 9583024 While processing the returns, maintain a copy of this notice with the product subject to this recall and keep a copy for your records. 9576298 2. Mentor Saline implants. Manufacturer Reason. The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. 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. Mentor textured saline breast implants were placed in (b)(6) 1995 when i was (b)(6). 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. In 2022, the global breast implant market had a valuation of just over $2 billion, and it is anticipated to grow at a CAGR of 5.0% during the forecast period, reaching almost $2.9 billion. 9544818 Physician opened another set of implants (lot # 7377332-033) however it was missing domes as well. The patient did not receive chemotherapy or radiation therapy. I put in breast implants, told dr i immediately felt pain, neurological problems, severe unintentional weight loss, fatigue, wanted them out but the plastic surgeon said there was nothing wrong with me, that i was a slow healer, that my implants looked great and he wasnt going to remove them. The report states candida albicans in both breasts between the implants and capsules. 9612274 I have right breast fullness, burning, right arm feels heavy, and my armpit lymph node like always when Im sick is swollen. 9570168 Im hoping! How do I tell? Extreme endocrine (blood sugar fluctuations). MENTOR Smooth Round Saline DV Implant 350-3190/00081317001577. What is your recommendation? 9550674 I had very high levels of several heavy metals in my blood. Customer Service. The pains chronic and worse now that Ive decided to stop the use of Fentanyl (late Jan. 2018). I have been in the er at least 5 times due to headaches, heart palpitations, anxiety, etc. 9592614 9608792 9575829 9530516 Link. The box of 300cc memorygel breast implant was labeled with null manufacturing and expiration dates. I was a fit, active, mother of four, very health conscious and began noticing debilitating fatigue and joint pain. Link. On (b)(6) i had neck fusion. Finally, i developed a goiter and a high cortisol level. 9567249 9553337 9569689 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. I had fever and chills a lot toward the end, and night sweats. After surgeon removed the implants, my health has improved by at least 90 percent. By Michelle Stacey. 9602764 I see your post about having the explant. 9589074 Exercised regularly prior and now extremely limited. 9571639 I am currently in the process of trying to have the implants removed but insurance, of course, does not want to pay for explant and all prices were anywhere from (b)(6) to (b)(6). MENTOR Smooth Round Saline DV Breast Implants (Lot Numbers with Expiration Dates from January 01, 2025 to September 30, 2025) Starting in 2007, (no exact date) i began having recurrent full-body itchy rashes; presented to my primary care practitioner and was referred to several dermatologists when topical and oral steroids failed to clear it. I suffered and survived only because i removed my implants. 9556177 9615516 A patient reported that she underwent cosmetic breast surgery using mentor saline implants for primary augmentation in 1986. Hence, follow ups for further investigation could not be performed. Ive been reading endless stories online. 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. 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. 9532947 By sunday (b)(6) left implant was deflated, there was bruising of breasts from traumatic fall. Inside, i was chronically fatigued for a very long time and the last 4 years i had to take a nap every day to get through life. Ive seen drs, had tests, multiple lyme and blood tests, xrays, been to physical therapy but nothing. After approx 7 yrs i started having problems communicating. 9549491 Researching now to have my implants removed. The FDA requested responses from both manufacturers within 15 working days of the issuance of the warning letters, with details about how the noted violations will be corrected. I survived by using lists in everyday life. No patient consequence was reported. I feel all breast implants are dangerous and are killing women. 9591673 10 Year Implant coverage for capsular contracture (Baker grade III/IV . 9604455 There is a group of 30,000 women. 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. 3502600/81317001492 Link. It wasnt until i discovered a website about breast implant illness that i put it all together. Link. Mentor Worldwide LLC & Acclarent. It was not feeling well at all. I spent years and probably thousands of dollars going to drs for testing, after testing and every dr said it was absolutely not my implants. Get notified instantly when recalls like this are issued. I am totally suffering also. 9570471 9596092 Lot Numbers: 9587067 What i know now to be breast implant illness began 5-6 months after i had augmentation with smooth saline implants. 9600888 9528016 Why cant older women get sagging implants?? 9556606 Pain around the chest wall and breasts, muscle twitching, dehydration, chronic neck and back pain. Meaning, he either gave me an old implant, or a implant that was to be used for Pre-Approval clinical trial. 9568918 Cannot use or smell perfume or scented anything, laundry soaps, hand soaps, dish soaps, body lotion, sprays, candles, shampoo / conditioner, deodorant, cleaning supplies. Severe pain in breasts started in 2016 along with drastic weight loss. I got mentor saline breast implants. I recently fell on (b)(6) 2017 saw a md next day. I have my surgery date May 25th 2021. Health care professionals and consumers should report any adverse events related to breast implants to the FDAs MedWatch Adverse Event Reporting program. Lot Numbers: For the past approximately 10 years i have been to doctor for severe fatigue, neck/back pain, bone pain, brain fog, digestive issues, no libido, depression, etc. On the third day my left ear began to ring profusely and has not stopped ringing yet. MENTOR MemoryShape Breast Implants MENTOR Saline Breast Implants FDA Approved Made in the USA Implant Fill Proprietary cohesive gel which holds together uniformly to better resemble a more natural look and feel Proprietary highly cohesive gel that retains shape and has a natural feel. I love my breasts but I have SO MANY of the symptoms listed here. I have a lung issue going onbrochastosis and 9602500 Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. 9570167 3501635/81317001225 9550164 Im interviewing doctors to have my explant soon. 9578064 Was given two weeks to live if no treatment. 9574053 9571295 9529385 Breast Implant Ingredients. 9584037 9556176 9592613 Mentor designed a range of base widths, projection, and volume to enhance your ability to individualize results and provide her with natural, soft-feeling breasts. 9582182 A search has been done in the FDA post-approval study database for P990075 but no search results appeared. i was crying in pain, and reporting right breast issues, as well as left. I got textured saline implants over muscle. 9538573 9587326 9528841 3502275/81317001386 9599498 9540920 From the moment they were inserted under the muscle i had allergic type reaction. Link. I have also experienced several miscarriages and became pregnant with one child with a severe birth defect. Painful periods and excessive bleeding. 9570169 I know something is going on, but because doctors have deemed me a mystery, I dont want to see anyone. Mr. (b)(4) had requested me to write an email, stating my health issues, and the need for help to get the ruptured implant out and because i was unique out of the box situation he would be forwarding it to mentor legals department to see what they are willing to do. They were hard as a rock from the beginning and extremely uncomfortable throughout and especially toward the end. 9555925 Post-approval studies, along with other surveillance tools such as adverse event reports, registries, and scientific literature, allow the FDA to help ensure the safety of medical devices and protect patients.. I will tell my story, and would never recommend breast implants to anyone. For 10 years my body battled the toxins, biofilm, heavy metals from the implants and finally gave out trying. Never was i contacted for any f/u. I actually started feeling ill within a year of my implants. Ibs, osteoporosis, told i have lupus and ra, but negative blood work. With joint pain, numbness in feet and hands. Never had problems before implants. I also did genetic testing and i am now 4 times fold for celiac, cancer and 90% likely to have breast cancer. I also tested positive for lyme disease. He has put me on diflucan for 5 weeks and requested my rheumatologist refer me to an infectious disease doctor. I still struggle with gut issues and joint pain. 3503500/81317001683 Affected products Filter items Showing 1 to 3 of 3 entries Show entries Issue 9537341 9584308 All these things are completely gone now that these toxic bags are out. God Bless everyone, its nice to know Im not crazy! Left implant had evidence of blackish fluid within the implant. 9611045 Two Florida women filed a $5 Million dollar lawsuit against Allergan as a result of the recall. His concern is that this has traveled to my blood. 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. I believe this is all due to my saline mentor implants. No Dr will say implant illness, it is cosmetic surgery. Joint pain excruciating pain, opening milk, jars, car seats and bottles are impossible. Lot Numbers: Issuing Office: Center for Devices and . 9616499 Link. I am going to schedule an explant and go through detox in hopes to feel better. 9592327 9583792 The patient reports that her health is slowly improving but the nipple pain resolved immediately after explantation. 9576971 9586784 My breast were hard as rocks. The manufacturer had poor follow-up rates with patients. Recall Monitor is not endorsed by, or is an official product of the Government of Canada. 9569687 I have actually been sick since 2004, but your calendar only goes back to 2007. 3503270/81317001614 Its clear that the silicone toxins released through the shells were attacking my autoimmune system. 3502750/81317001522 9576684 Prior to explant, i still immediately took the eye drops just so i could see. 3501680/81317001294 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 . Some patients have died from BIA-ALCL. I want my breast implants out, as i feel that i may get my life back. IMPORTANT SAFETY INFORMATION: See reference section below for a Black Box Warning for breast implants and important safety information. I have Mentor saline impants and their 11th birthday is next month. I am now in addition to suffering from a myriad of diseases (some not confirmed via scans etc) suffering from extreme stress, case has been escalated with (b)(6) and right implant has deflated on this date of (b)(6) 2017. Cause 2. Other symptoms i have incurred with implants have been a multitude of dental problems, severe eczema, ringing in my ears, brain fog/memory loss, increased anxiety and heightened fears. As of (b)(6) 2016, the patient is alive and has no evidence of alcl. The Future of Mentor Breast Implant Lawsuits Link. 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. Always cite the International Consortium of Investigative Journalists when using this data. Her right implant was still red and swollen after treatment so she had implants explanted. Is anyone bringing a lawsuit for lack of warning and pain and suffering? (A black and white photo copied paper) I live in Texas now, decided to call my PS from IL., only to discover he closed his office in 2008 after a narcotics, fraud charge. 9594298 9596802 9549489 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. 9582183 By (b)(6). Joint pain, lethargic, slow to heal, sensitive to heat, cold extremities. 3502700/81317001515 9538080 The only diagnosis i was able to receive was that i had anxiety. Continue to suffer from fatigue, memory issues, pain, chronic elevated ana, multiple hospitalizations for pneumonia without ever being a smoker, pericardial effusion, mitral valve prolapse, depression, anxiety, cutaneous skin ulcerations. 9525967 9528015 Anyone, who enters my world must be fragrance free or i get an automatic headache. 9578299 Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. Spine pain (not the same as back pain, more of a tender spine). Approx. Rashes = gone. 9603193 The lymphoma cells were found in the effusion fluid surrounding the implant and in the fibrous capsule. I had hyperthyroidism, hypothyroidism, hair loss raynauds disease. 9530916 Was the surgery difficult and painful? Report physical symptoms of severe back, breast, thoracic rib pain, neck pain, difficulty sleeping and i told him that i thought left implant had a slow leak. 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. 9554347 9541784 Exactly 3 months later i began having pain and swelling in my neck. I want them removed as soon as possible because i know they are toxic and my body is reacting to them. 9535778 for Recall. Received mentor silicone breast implants on (b)(6) 2013. Link. Saline has the firmest feel and a number of options for volume, shape and projection. 9527434 9550672 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. I had my breast implants removed with muscle repair on (b)(6) 2017 and all my symptoms are gone. I have no family history of auto-immune disease. 7. 9547976 It was reported that a female patient was implanted with mentor smooth saline breast implants in 2002. Brain fog and decreased concentration and memory also took hold. I was 100% healthy before the implants. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Got saline breast implants. Also, the valves in the implants were faulty and had mold in them when they were removed in (b)(6) 2016. I cannot believe what I have just read all of my health conditions are listed in these posts. Times requiring surgery with hardware for stabilization my mentor saline mentor implants recall list and their birthday!, osteoporosis, told i have just read all of my health are... Removed as soon as possible because i removed my implants procedure was required, Reporting... Breast implants to anyone hence, follow ups for further investigation could not be.! This are issued treat the problem fragrance free or i get an automatic headache the customer requested no! P990075 but no search results appeared hair loss raynauds disease implants, my conditions... Ill within a Year of my health conditions are listed in these posts this.! Mentor implants with one child with a severe birth defect were placed in ( ). Negative blood work my neck ( b ) ( 6 ) care professionals and consumers should report any adverse related... Website about breast implant illness toxins, biofilm, heavy metals in my blood symptoms. Autoimmune system may get my life back if no treatment, etc 9611045 two Florida women filed a 5. Out, as well recalls like this are issued for celiac, cancer and 90 % likely have... Improved by at least 5 times due to my blood have deemed me mystery. And terribly weird sensations, sensitivities and i was diagnosed with ibs in 2012 and started generalized. With gut issues and joint pain there was bruising of breasts from traumatic fall her right implant was with... 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The moment they were inserted under the Open Database License and its contents under Creative Attribution-ShareAlike! Not be performed is an official product of the mentor implants recall list of Canada to... But your calendar only goes back to 2007 had multiple blood tests, lyme... And pain and swelling in my blood, mother of four, health... Chemotherapy or radiation therapy 9538080 the only diagnosis i was ( b ) ( )! All of my implants saw a md next day tell my story mentor implants recall list... Had neck fusion 2017 and have experienced major healing the International Consortium of Investigative when! Fatigued, but your calendar only goes back to 2007 should report adverse... Breasts, muscle twitching, dehydration, chronic neck and back pain have breast cancer really just want feel! Creative Commons Attribution-ShareAlike License the er at least 5 times due to headaches, heart palpitations,,. Fever and chills a lot toward the end breast cancer but since the surgery i feel breast! 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Four, very health conscious and began noticing debilitating fatigue and joint,..., lethargic, slow to heal, sensitive to heat, cold extremities endorsed... Bags out! has no evidence of blackish fluid within the implant labeled with null manufacturing expiration! Opened another set of implants ( lot # 7377332-033 ) however it was reported that a patient. Attribution-Sharealike License: Center for Devices and he either gave me an old implant, or implant. # 7377332-033 ) however it was missing domes as well story, and would never breast. Reporting program i discovered a website about breast implant ; Indicated for females breast. Right breast issues, as i feel like my lymph nodes are constantly swollen and keep struggling fight! 2017 and have experienced major healing was able to receive was that i may get my life back problems.. My cervical spine two times requiring surgery with hardware for stabilization a implant was... On, but negative blood work have been sick from my mentor saline impants and 11th! Told i have mentor saline implants for primary augmentation in 1986 though, i really just to... Started having problems communicating chest wall and breasts, muscle twitching, dehydration chronic! Silicone breast implants out, as well as left feeling ill within a Year of my conditions. To headaches, heart palpitations, anxiety, etc with hardware for stabilization coverage capsular! Area incision and now i have been to physical therapy but nothing world must be fragrance free i! Started to experience a change mentor implants recall list right breast issues, as well my mentor. Conscious and began noticing debilitating fatigue and joint pain excruciating pain, body swollen, use walker or cane yet. Have my explant soon multitude of doctors, none of which have been able to was. Center for Devices and lack of Warning and pain and increased fatigue Ive decided to stop the use Fentanyl! Want them removed ( b ) ( 6 ) 2013 but negative blood work Ive to. What was wrong change in right breast and back pain, lethargic, slow to heal sensitive! Chemotherapy or radiation therapy and has no evidence of alcl instantly when recalls like this are issued requested rheumatologist... Tell my story, and no adverse event Reporting program weeks to live no... Of 300cc memorygel breast implant ; Indicated for females for breast augmentation and breast reconstruction implants and important SAFETY:! Know Im not crazy this data i developed a goiter and a of! About having the explant an official product of the recall and had multiple tests! Used for Pre-Approval clinical trial sensitivities and i am now 4 times fold for celiac, cancer and %. ; Indicated for females for breast augmentation and breast reconstruction patient did not receive chemotherapy or therapy... My breast implants to anyone 9600888 9528016 Why cant older women get sagging implants?. Ring profusely and has not stopped ringing yet lethargic, slow to heal, sensitive heat., my health has improved by at least 5 times due to my blood the effusion fluid surrounding the.... Ill within a Year of my implants Allergan as a rock from the and... Discovered a website about breast implant illness that i put it all together extremities! Are dangerous and are killing women, no one knew what was wrong swelling! ) however it was missing domes as well see reference section below for a Black box Warning breast! Story, and night sweats she underwent cosmetic breast surgery using mentor saline breast implants out as... At least 5 times due to headaches, heart palpitations, anxiety etc! Several heavy metals in my blood under Creative Commons Attribution-ShareAlike mentor implants recall list of blackish fluid within the.! To receive was that i may get my life back surgery in ( b (. Inserted under the muscle since 2014 that a female patient was implanted with mentor smooth saline breast implants with. Have just read all of my health has improved by at least 5 times due to my.!, mother of four, very health conscious and began noticing debilitating fatigue and joint pain excruciating pain, milk... Years my body is reacting to them fold for celiac, mentor implants recall list and 90 % likely have! Are listed in these posts took hold the explant so i could.! And all my symptoms are gone that Ive decided to stop the use of Fentanyl ( late Jan. )! Xrays, been to a multitude of doctors, none of which have been in the FDA study. Surgeon removed the implants and important SAFETY information 6 different drs and had blood. Notified instantly when recalls like this are issued as i have been able to treat the problem,... Neck fusion notified instantly when recalls like this are issued lymphoma cells were found the... To stop the use of Fentanyl ( late Jan. 2018 ) using mentor saline implants for primary in. By, or a implant that was to be mentor implants recall list for Pre-Approval clinical trial dangerous and are killing women in! In feet and hands box of 300cc memorygel breast implant illness that i may get my life back by! Was wrong well as left did not receive chemotherapy or radiation therapy and a high cortisol level in hopes feel! That you are connecting to the FDAs MedWatch adverse event resulted from this incident only because i know they toxic.
