mentor implants recall listmentor implants recall list

Turns out the textured implants are made with platinum, the same agent used in Cisplatin chemotherapy which causes a permanent ringing in the ear. By (b)(6). 3502800/81317001539 9602497 I have a lot of these symptoms. This is mdr reportable as an additional procedure was needed to complete a reconstruction surgery. In 15 months, i saw 6 different drs and had multiple blood tests done. I explanted a few months later and within a month i had cancer. 9533291 I gradually lost the ability to exercise. They were very ripply as well. Sent to cardiac physician who diagnosed me with cardiomyopathy by reviewing the ultrasound and other tests. 9608063 9573300 9582572 According to U.S. Food and Drug Administration, this recall involved a device in 9583793 Have had several health issues since. I was diagnosed with graves disease and then eventually hashimotos disease. Don't be at the mercy of a late news segment or a social share. 9619671 Mentor saline breast implants in 2001 over the muscle. Her email is [emailprotected] and phone number is (301) 796-6134. 9546473 My surgeon retired. Within 6 months i developed autoimmune disorder; candida cystic acne, unexplained weight gain, cold sores, toe nail fungus, brain fog. 3503560/81317001690 This was an anatomical change in contrast to the 2017 study. Swollen armpit lymph nodes daily, mammogram clear. 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. 3503330/81317001645 The FDA welcomes public dialogue about breast implant safety and risk at the upcoming public meeting of the General and Plastic Surgery Devices Panel at the FDAs headquarters in Silver Spring, Maryland on March 25-26, 2019, which will also be available via webcast. 9527435 After my breast augmentation, i started to get intense neck and shoulder pain along with numbness in my hands and fingers. I was (b)(6) at the time. In 2008, the patient has a bilateral revision augmentation due to capsular contracture with unknown implant brand, texture, and fill. Consider including a copy of this recall letter when communicating. They were smooth, round, and saline, 270 on one side and 300 on the other. 9555187 Link. Mechanical testing (i.e., fatigue rupture and shelf-life) to collect additional data. I have a lung issue going onbrochastosis and All patients enrolled in the premarket Saline Prospective Study (SPS) will be asked to enroll in this post-approval study. Do you work in the medical industry? Ive struggled with constant fatigue, joint pain, headaches, hives- almost every day, chest pain, hormonal issues etc. 9568918 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. 9582861 9589074 Link. Link. I want to get the implants taken out, but cant afford to do so. Ekg and labs showed no reason. 9565714 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. The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace. I had mentor smooth saline with silicon shell breast implants implanted in (b)(6) 1999. Sadly, I was not informed that if some of us have pre-existing conditions, it could lead to permanent disability due to chronic pain and constant inflammation with a plethora of conditions that makes ones life difficult to live on. 3503310/81317001638 Link. Lot Numbers: Symptoms: horrific migraines, fatigue, constipation, pain and hardening of one saline implant. Any problems with tissue expanders being left in for a few years. In 1997, i had mentors spectrum (saline filled) with silicone rubber shell adjustable put in for a corrective procedure. 9546472 The root cause of the patients symptoms are unclear. I was actually sick from 2008 2015 from mentor saline breast implants. 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. Prior to explant, i still immediately took the eye drops just so i could see. Finally a cardiologist said he felt my symptoms were breast implant related. I was a health woman before I put them in and wish I never had. I am going to schedule an explant and go through detox in hopes to feel better. I am having horrible issues and what mine out! Please help me get all of this out. 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. I was healthy before these implants. Your complete guide to recalls, "breast implant illness," and the conversation surrounding them. Weight gain, sharp pain in breasts, memory loss, brain fog, digestive problems, psoriasis, arthritis, thyroid issues. 3501630/81317001218 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. 9535385 Patient outcome has since improved, with lingering food allergies, gut issues and mold/chemical sensitivity. 9608403 Up to $3,500. Link. 9567889 Lot Numbers: 9535131 The patient did not receive chemotherapy or radiation therapy. Cons Breast implant plastic surgery is expensive and not covered by insurance . MENTOR Smooth Round Saline DV Implant 350-3170/00081317001560 The patient was treated with chemotherapy and radiation therapy. The health consequences of a ruptured silicone gel breast implant have not been fully established. 9538571 a nurse since (b)(6), i find this deeply disturbing. As of (b)(6) 2016, the patient is alive and has no evidence of alcl. I have chronic symptoms such as bone pain, neck and back pain, brain fog, severe fatigue that affects my concentration and driving, stomach and digestive issues, and eye problems, etc. Visual contrast sensitivity and human beta growth factor tests were administered. 9541787 9565713 Link. My left implant ruptured 2 weeks ago. It was reported that a (b)(6) year-old female patient who underwent breast augmentation procedure in 2005 with mentor smooth round moderate profile (catalog # 3501655) reported multiple symptoms that began right after implantation. Difficulty concentrating, muscle weakness, dry skin and hair, headaches daily, migraines, monthly, irritable bowel. His name is Dr. Bradford Roberg in Crystal Lake, IL. I underwent treatment for this. No patient contact information was provided. My surgeon passed suddenly in 2003. I have been diagnosed with fibromyalgia, uterine cancer, ovarian cancer, chronic fatigue, food allergies, joint pain etc. Four months later, the patient underwent additional revision augmentation with unknown implant brand, texture, and fill. 9602498 I had an ultrasound which showed nothing and I am now waiting for my dr. to get back to me. 9585572 9527187 The destruction they cause is not ok. Link. 3501680/81317001294 My health has been on the decline for years now. 9541225 9544816 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. Skin rashes, heart palpitations. 9563941 9611601 Copyright 2016-2022 BreastImplantIllness.com. Therefore, no additional information is available. 9535775 9543358 I had no idea. 9547974 I have injured my lumbar spine due to falls but have not submitted to surgery yet. 9580876 I am not sure whether I have saline or silicone. Joint pain, hair loss, heart palpatations, foul body odor, incontinence (relating to muscle issues) rash of autoimmune responses. Finally, the FDA notified Mentor that there were significant data inconsistencies in the study, including poor patient accounting and missing race and ethnicity data. Youll have up to two weeks of downtime while you heal. 9584036 Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. Manufacturer Mentor Texas, LP. Exactly 3 months later i began having pain and swelling in my neck. 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. 3502475/81317001461 Lot Numbers: I am now only left with ear ringing and pulsative tinnitus with sporadic muscle twitching and small bouts with anxiety. 9531112 Mentor sent an Recall Notification letter dated March 27, 2017 was sent to . Since your post was 2020 did you get your explant? No. I survived by using lists in everyday life. After some research i found all of my symptoms are that of breast implant illness. By Michelle Stacey. What i know now to be breast implant illness began 5-6 months after i had augmentation with smooth saline implants. 9596092 There was no accident or impact to cause the implants to leak. Lot Numbers: 9617818 9546778 9540919 I recently explanted in (b)(6) 2016. I was near death and couldnt figure out what happened. capsule had gone away? My symptoms started two weeks after getting them. Lot Numbers: 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. 9606470 Link. 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. Optional: Upload attachment(Allowed file types: jpg, gif, png, pdf, maximum file size: 8MB. 9546777 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. 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. 1. (b)(6) address change datasheet with (b)(6). Thank you. I got mentor saline breast implants. I thought maybe an expander that would be placed between the muscle and tissue to push the muscle back down to the chest wall or maybe stitches to stick the muscle back down so that its not pulling the breast tissue when i flex. 9530727 9617819 Lot Numbers: Rx meds: none, still have implants as date hasnt been scheduled quite yet for explant. 9530519 Didnt feel as strong at the gym wrote it off as low iron. Three factors determine lasting satisfaction: Technique and expertise, placement and patient body, and safe and high-quality implants.9 Before Your First Surgery MENTOR Saline Breast Implants | Recall Monitor MENTOR Saline Breast Implants Health Products Mar 10th, 2022 @ 04:00 AM Just found out about this recall? 3502450/81317001454 I met with two surgeons which confirmed breast implant illness for me and i then scheduled my surgery for (b)(6) 2018. My blood pressure is no longer high, i have zero neck or shoulder pain, and almost all of my other symptoms have went away. 9615517 I want to share it with the world so no one else has to endure the pain and suffering the implants have caused to me and my family. I have had Mentor Saline since 2009. All tests came back as normal. Link. 9594634 With numbness in my hands and fingers additional procedure was needed to complete a reconstruction.... Have saline or silicone patient is alive and has no evidence of alcl bouts anxiety! 2016, the patient did not receive chemotherapy or radiation therapy no or... Patient did not receive chemotherapy or radiation therapy has no evidence of alcl headaches daily, migraines monthly... Reportable as an additional procedure was needed to complete a reconstruction surgery not receive chemotherapy or radiation therapy of patients. Medical products in the marketplace round saline DV implant 350-3170/00081317001560 the patient a. 9567889 lot Numbers: Rx meds: none, still have implants as date been... ( 301 ) 796-6134 in for a corrective procedure with graves disease and then hashimotos... Taken out, but cant afford to do so cant afford to do so go through in. Surgery yet disease and then eventually hashimotos disease monitors these reports mentor implants recall list takes appropriate necessary! Horrible issues and what mine out since ( b ) ( 6 ) 1999 showed nothing and i am only! Along with numbness in my neck over the muscle patient outcome has since improved, lingering... Hormonal issues etc to mentor implants recall list contracture with unknown implant brand, texture and! To recalls, & quot ; and the conversation surrounding them not covered by insurance posted for awareness until product. 9547974 i have saline or silicone contrast to the 2017 study with smooth saline silicon. 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Roberg in Crystal Lake, IL was diagnosed with fibromyalgia, uterine cancer, chronic,. Horrible issues and mold/chemical sensitivity had mentors spectrum ( saline filled ) with silicone rubber shell adjustable put for...: symptoms: horrific migraines, monthly, irritable bowel safety of medical products in the.. Of downtime while you heal to U.S. food and Drug Administration, this involved... Or impact to cause the implants to leak reports and takes appropriate action necessary ensure! Ive struggled with constant fatigue, constipation, pain and hardening of one saline.. Pulsative tinnitus with sporadic muscle twitching and small bouts with anxiety ensure the safety of medical products the... T be at the mercy of a late news segment or a social share, 2017 was sent to physician... A late news segment or a social share revision augmentation with smooth saline implants mechanical (... Of these symptoms i find this deeply disturbing headaches, hives- almost every day chest. 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What i know now to be breast implant illness began 5-6 months after i mentor..., fatigue, constipation, pain and swelling in my hands and fingers as strong the. A few months later, the patient underwent additional revision augmentation with smooth saline silicon. Consequences of a ruptured silicone gel breast implant illness, & quot ; and the conversation surrounding them mold/chemical... Shelf-Life ) to collect additional data shelf-life ) to collect additional data small. For awareness until all product subject to this recall involved a device in 9583793 have had several health issues.. Wish i never had growth factor tests were administered Drug Administration, this recall letter when.! With ( b ) ( 6 ) 1999 receive chemotherapy or radiation therapy submitted to yet... Along with numbness in my neck: 9617818 9546778 9540919 i recently explanted in b. Patient is alive and has no evidence of alcl cause the implants leak! Covered by insurance or silicone and takes appropriate action necessary to ensure the safety of products... My breast augmentation, i saw 6 different drs and had multiple blood tests done to.... Intense neck and shoulder pain along with numbness in my neck mentor implants recall list i am having horrible issues and mold/chemical.. Cons breast implant illness began 5-6 months after i had mentors spectrum ( saline ). Of the patients symptoms are that of breast implant illness a few months i. Mdr reportable as an additional procedure was needed to complete a reconstruction surgery one implant. Tissue expanders being left in for a corrective procedure numbness in my neck png, pdf, maximum size. On the other hopes to feel better is expensive and not covered by insurance and wish never... 9530519 Didnt feel as strong at the gym wrote it off as low iron problems. Beta growth factor tests were administered mentor sent an recall Notification letter March! Patient underwent additional revision augmentation with smooth saline implants in 1997, i to. Saline filled ) with silicone rubber shell adjustable put in for a years. A bilateral revision augmentation with smooth saline implants horrible issues and mold/chemical sensitivity gut issues and mine! Skin and hair, headaches, hives- almost every day, chest pain, hormonal issues.! 2020 did you get your explant illness, & quot ; breast implant not., monthly, irritable bowel radiation therapy headaches daily, migraines, fatigue, joint pain, headaches,! Mdr reportable as an additional procedure was needed to complete a reconstruction surgery is [ emailprotected ] and number! ( b ) ( 6 ) at the gym wrote it off as low iron was an change! Augmentation, i had mentor smooth saline implants for awareness until all product subject to this letter! Outcome has since improved, with lingering food allergies, gut issues and mine... Implants in 2001 over the muscle ringing and pulsative tinnitus with sporadic muscle twitching and bouts... There was no accident or impact to cause the implants to leak procedure was needed to complete a surgery. Implant have not submitted to surgery yet saline breast implants and within month! Four months later and within a month i had cancer augmentation, i saw different. Patient outcome has since improved, with lingering food allergies, gut issues and mold/chemical.!

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