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. capsule had gone away? Bruising on body, brain fog, joint muscle chronic pain, body swollen, use walker or cane. 9550165 I have fallen and injured my cervical spine two times requiring surgery with hardware for stabilization. I eventually closed my business as i could no longer teach fitness classes. This needs to end. 9568918 My aerobic capacity diminished and recovery from my own personal workouts was long. Was given 20 percent chance of survival if treated but i had no choice but to go through a stem cell transplant, given a 20 percent chance of surviving transplant, or i would only live a few months after remission. 9557442 9608063 I feel all breast implants are dangerous and are killing women. URGENT: FIELD SAFETY NOTICE . 9531110 By 2004 i found it impossible to work at all, i was only (b)(6). 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. 9569690 Over the past 20 year time span, I have had all over body psoriasis, chronic migraines, joint aches, left shoulder blade pain, hypothyroidism requiring meds, sinus issues, dry mouth, throat clearing, optic neuritis in my right eye, IBS, pulmonary sarcoidosis, and thumb numbness. Link. Link. 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. 9569688 9569246 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. Lot Numbers: Currently, the manufacturer reported a follow-up rate of 61 percent, which is below the target follow-up rate. I am desperately trying to get funds together to have them removed. I had a right ruptured mentor breast implant that was removed and replaced on (b)(6) 2002. 9538081 My skin was aging rapidly the last year, and now that the implants are out, the age spots have lightened and i have been complemented on my glowing skin again. Link. 9552230 My gut lining was very damaged from the heavy metals in the lining of the implants. 9546175 I underwent treatment for this. 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. 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. 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. 9582571 I am two weeks out from surgery and i am healing every day. Now i contacted mentor a few days ago to speak with mr. (b)(4), as i had previously asked who would help me cover the new surgeons expenses, only to find mr (b)(4) was unavailable and the new supervisor couldnt locate me like mr. (b)(4) had been able to. Link. I ultimately explanted in (b)(6) of 2016. 9615516 Link. 9563940 3502250/81317001379 Lot Numbers: Testing was done immediately as well as steroid treatment and then other immune modulating drugs. One year later, i started to have all kinds of injections and then started getting dizzy ended up bedridden for a year. 9544818 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. 9612274 Lot Numbers: Fda confirms all are bad, then recall any implants and make mentor, dow corning, allergan, etc pay for full explanation of all implants, including capsule and repair damage done to womens bodies. The same device may have different names in different countries. Especially the last year. Also, the valves in the implants were faulty and had mold in them when they were removed in (b)(6) 2016. 9564916 9616495 Patient was under general anesthesia for 4 hours (from 7:46am to 12:06pm). Among many symptoms that make me feel like im dying a slow death. Link. After approx 7 yrs i started having problems communicating. They are getting better? I could not get a deep breath. Trying to figure out what to do. For 10 years my body battled the toxins, biofilm, heavy metals from the implants and finally gave out trying. I know it was the implants pushing on my chest, probably due to the capsular contraction. This is outrageous! I was actually sick from 2008 2015 from mentor saline breast implants. 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!!!! I had the mentor saline implants 14 years ago. 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. 9550164 Link. Link. 9541226 I was depressed, no one knew what was wrong. I was healthy, more than healthy. 9577403 3. 9553111 I ran my own fitness business, i began having heart palpitations and tightness in my chest. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and fax/email to Sedgwick at 888-912-7086 or mentor7209@sedgwick.com within 3 business days. Link. 9541783 9563942 9611602 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. You can access this data free of charge via Recall Monitor, or through the Healthy Canadians website. My youngest adult son of three children told me there are many women reporting these issues. Please do something. 9587326 9529875 My problem, I found all the paperwork my ex-husband gave me, even the Mentor warranty sheet. 9570470 I was (b)(6) at the time. I continue to work, but have such horrible brain fog that it worries me. For instance, FDA staff have coordinated with the American Society of Plastic Surgeons and the Plastic Surgeons Foundation to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (BIA-ALCL) Etiology and Epidemiology (PROFILE), which collects real world data regarding patients who have a confirmed diagnosis of BIA-ALCL. My eyes and mouth became unbearably dry. 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. I recently explanted in (b)(6) 2016. Now i read that every symptom could be related to implants. I then began having issues with female health, cysts during ovulation, fibrous dense breast tissue that eventually also led to cysts. 9591673 Hence, follow ups for further investigation could not be performed. Always cite the International Consortium of Investigative Journalists when using this data. 9540916 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. Woke up systemically ill and in widespread body pain. Link. Link. Lot Numbers: Left implant had evidence of blackish fluid within the implant. 9612275 The patient then began having problems in left breast (capsular contracture) and underwent revision procedure with unknown implant brand, texture, and fill. Sientras failure to address these concerns and comply with its post-approval study requirements is a violation of the firms pre-market approval order. Mentor offers protection for their products such as: Free lifetime replacement if your implant rupture. i want my life back, or at least the chance. 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). A lower risk of complication is rupture. 9525967 There should be some kind of warning about the dangers of breast implants. I take vitamins and try to eat healthy. I was in bed longer periods than up. my breast implants due to cancer? 9614480 9629166 The FDA needs to know what is going on. FDA Documents: Approval Date: May 10th, 2000 Medical Device Recall Search On monday (b)(6) 2017, i went to (b)(6). 9608404 Mold toxicity was suspected, so the patient underwent bilateral explantation on (b)(6) 2015. Mentor Texas LP. I tried to register with MENTOR online, but they do not acknowledge my serial number or information even though I have proof they are in my body. The FDA remains committed to thoughtful, scientific, transparent, public dialogue concerning breast implant safety and effectiveness. 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. Optional: Upload attachment(Allowed file types: jpg, gif, png, pdf, maximum file size: 8MB. 9582184 They were hard as a rock from the beginning and extremely uncomfortable throughout and especially toward the end. 9555187 9559143 Implantation of the MENTORBreast Implants, as well as any subsequent procedures, must be in accordance with current Mentor Product literature and accepted plastic surgical procedures by appropriately qualified licensed physicians for product to qualify for replacement under the Mentor Product Replacement Policy. Mentor textured saline breast implants were placed in (b)(6) 1995 when i was (b)(6). In 2008, the patient has a bilateral revision augmentation due to capsular contracture with unknown implant brand, texture, and fill. 800-235-5731. Severe pain in breasts started in 2016 along with drastic weight loss. I believe the bodys eventual reaction to the implants aged me prematurely. Lot Numbers: 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. I wanted to know how many women had been diagnosed with lymphoma. No contact information was provided in mw report, therefore no further information has been made available. This is event was reported via # mw5023558. 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. However the delay caused a potential risk to the patient. Extreme fatigue, sinus pain and achy. Frequent urination, numbness/tingling sensations in upper and lower limbs, cold and discolored limbs, hands and feet, general chest discomfort, shortness of breath, pain and/or burning sensation around implant and/or underarm, liver and kidney dysfunction, cramping, toxic shock symptoms, anxiety, depression and panic attacks, leaky gut, ibs and sibo symptoms of or diagnosis of fibromyalgia, symptoms of or diagnosis of lyme disease, symptoms of or diagnosis of auto-immune diseases such as; raynauds syndrome. MENTOR Smooth Round Saline DV Implant 350-3170/00081317001560 9563940 3502250/81317001379 lot Numbers: Left implant had evidence of blackish fluid within the implant for 4 hours from. 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