9527436 5. There was no accident or impact to cause the implants to leak. Here is my list of health issues, that began in 2011. I had the mentor saline implants 14 years ago. During routine set up, the physician found that the package of the implant did not contain the dome pack accessory. 9536098 Upon follow-up, it was confirmed by the patient that the symptoms were experienced three months after the implantation and they are slowing going away after the explantation. I had hyperthyroidism, hypothyroidism, hair loss raynauds disease. 9532946 Over the next 6 years i began to experience various symptoms such as daily headaches, insomnia, anxiety, and brain fog that i just wrote off at the time. 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. The FDA needs to know what is going on. Recall Status 1: Terminated 3 on June 13, 2017: Recall Number: Z-2070-2017: . I was diagnosed with graves disease and then eventually hashimotos disease. 9559883 Link. 9619995 They should be remove from all surgeries. 9616499 9555186 9565270 I went on a (b)(6) breast explant group to solicit recommendations for explant surgeons. 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. Manufacturer Issues: It was reported by a physicians office that a mentor smooth round moderate profile saline implant (catalog #3501670, serial # (b)(4)) had an out of box issue. My brain fog is nearly gone now, and i no longer need daily naps. No. 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. On 10/11/2021, the Firm sent an "URGENT MEDICAL DEVICE RECALL (REMOVAL)" Notfication via UPS informing customers that breast implants which have expiration dates from 01/01/2025 to 09/30/2021, due to a manufacturing issue may have a potentially weakened area on the base patch portion of the shell. It was reported that a female patient who underwent primary breast augmentation with mentor smooth round moderate plus profile saline implants (catalog #3502450, (r) serial #(b)(4), (l) serial #(b)(4)) in (b)(6) 2015 underwent bilateral explantation on (b)(6) 2017. Before sharing sensitive information, make sure you're on a federal government site. 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. MENTOR Smooth Round Saline DV Breast Implants (Lot Numbers with Expiration Dates from January 01, 2025 to September 30, 2025) 9534032 9595693 My youngest adult son of three children told me there are many women reporting these issues. I had lime green nipple discharge on the right side and blood coming out the left breast nipple. Mentor Siltex breast implants and anaplastic large cell lymphoma 27 March 2020 Johnson & Johnson Medical New Zealand Ltd is notifying surgeons that these devices carry a risk of breast implant associated-anaplastic large cell lymphoma (BIA-ALCL). 9553111 i no longer had shortness of breath. 3502475/81317001461 So many BII symptoms, this isnt living. Lot Numbers: Unable to work. Link. How will I recover this information? If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. I wish these side effects and possibility for this happening would have been explained to me. 9607487 Who do you recommend remove my implants? Depression, asthma, hard time breathing at times. 9617100 Link. 9546778 My implants were put in in 2008 and were Mentor Saline Implants. 9582573 Eczema on about 50 percent of my body as well. 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. I began to experience anxiety and panic for unknown reasons so i began increasing my b vitamins, but nothing helped. 9573063 Mentor offers protection for their products such as: Free lifetime replacement if your implant rupture. Ibs, osteoporosis, told i have lupus and ra, but negative blood work. Ekg and labs showed no reason. Not to mention people thinking you are imagining all of this. 9558225 9538571 All the plastic surgeon will offer me is a lift on my good breast, which she already reduced in half in 2015 with large lumpectomy. Does anyone have any experience with breast pain? 9586122 9603193 The patient has no history of medical problems. 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. I found a new surgeon and had them taken out immediately. 9540919 9567889 Didnt feel as strong at the gym wrote it off as low iron. 9570470 I will explant next week to get my life back. 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. Link. Lot Numbers: Link. I had testing done on my eyes to see if my oil glands had degraded. 9546176 Despite being in total shock that this male muslim doctor decided to go against my choice of implants, within a few days I began to have major symptoms. Lot Numbers: There is not a recommendation that women who have had these implants placed explant them. I have a lung issue going onbrochastosis and 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. 9616497 4. Testing was done immediately as well as steroid treatment and then other immune modulating drugs. 9535385 3503330/81317001645 Lot Numbers: 3502650/81317001508 This cancer occurs more commonly in patients with textured breast implants than smooth Implants, although rates are not well defined. Link. Premature aging, vision disturbances, digestive issues. I grew up very athletic, so this was like dying. 9614477 9565271 Blurry vision, visual disturbances, bruising takes months to heal, wounds take months to heal. The implants were found with faulty valves and mold. 9614480 I used to work 80 hours a week and raised 4 children alone. I had a right ruptured mentor breast implant that was removed and replaced on (b)(6) 2002. 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. Since then i have had to take coreg cr 20 mg to help my heart. 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 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 was informed that many women are having similar issues that have breast implants. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. 9591673 The addition of prescription eye drops that helped, but my eyes were still red and dry. As a result, the patient had undergone explantation on (b)(6) 2018. Link. Since your post was 2020 did you get your explant? 9563095 9535773 No contact information was provided in mw report, therefore no further information has been made available. 9615896 They opened another implant for the missing items and procedure was completed. 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. I even developed (b)(6) 3 weeks after the surgery under my armpit, which ive never had. Please do something. I had mentor smooth saline filled under the muscle breast implants. 9597481 The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. Link. Within 3 months started having pain. I was on biologic drugs several years without any relief of joint pain or swelling. Im getting worse. I was treated by several different dermatologist with steroids im as well as into the bald patches on my head. The patient reported that her blood is screaming disease and infection. One year later, celiac, other food allergies, biotoxin illness, severe symptoms that were debilitating, digestive issues, leaky gut, chemical sensitivity, light and sound sensitivity. The research person on the phone was very dismissive and said that such records were not kept. I had mentor smooth saline with silicon shell breast implants implanted in (b)(6) 1999. Among many symptoms that make me feel like im dying a slow death. Ive had tests done and never anything found. 9527187 Mechanical testing (i.e., fatigue rupture and shelf-life) to collect additional data. Link. Blurred vision and overall exhaustion. I was tested for a multitude of disease such as lyme, eb, anemia, ms, als, etc. Ive had chronic infections since these were placed. Temperature intolerance even if the house is 77 degrees during the summer, i have sweat clothes on. All rights reserved. 9532947 Mentor sent an Recall Notification letter dated March 27, 2017 was sent to . I was healthy prior to 5 years ago, currently show autoimmune symptoms with neg blood work. my first ones were removed via the area incision and now i have an incision in the inframammary location. its an infection. 9595426 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. Started showing symptoms in 2012. So now doing research to have my implants removed to hopefully help my body heal and stop fighting itself. Some symptoms have already gone away and some have gotten better. 3502400/81317001430 9534031 9564914 By 2004 i found it impossible to work at all, i was only (b)(6). 9597740 It has been 1.5 years. It was reported that a (b)(6) year old female patient who underwent breast prostheses implantation in 2009 with mentor saline smooth round moderate plus profile implants 350cc (catalog # 3502350, lot # 5915659) experienced bilateral discomfort and aching. I did research what i could find previous to getting my implants and found no negative reports at that time. It is despicable. Lot Numbers: Do you think that made a difference in the muscle deformity? It is important that you read and understand these brochures when considering MENTOR Breast Implants.