I was fine for the first two years. I was healthy and active prior to breast implants. How to Setup a Mentor Breast Implant Serial Number Recall. endstream endobj startxref There is no specific information regarding any diagnoses or symptoms. Link. Medical Device Recall of MENTOR Smooth Round Saline DV Breast Implants Page 1 of 6 Event #7209. For Additional Information Contact. I contacted a plastic surgeon at (b)(6), and scheduled an explant. Hypothyroid, coughing, intolerant to heat and cold, new and persistent viral infections, candida, constant yeast infections. Redness all over my body. Update on the Safety of Silicone Gel-Filled Breast Implants, MemoryShape and MemoryGel Post-Approval Study. Note: If you need help accessing information in different file formats, see All symptoms started on the right side of my body, and were more severe than on the left side of my body. The patient sought treatment from several physicians, who concluded that the implants were responsible for patients condition. Contact the relevant medical authorities who conducted the surgery and request an updated Mentor breast implant recall information. The patient must be given the opportunity to initial and sign the patient decision checklist and it must be signed by the physician implanting the device. I have been unable to return to the job that i loved. This is socially unacceptable because i have to cough and spit all the time trying to get this extremely sticky substance out of my throat. MemoryGel breast implants come in either a textured or smooth surface shell and are available in a wide range of sizes and profiles to fit your body. Both of the implants had holes. Link. I am getting sicker and sicker. Implants robbed me of a year of my life!. I havent even had a cold for at least 2 years or more. Customer Service. I developed raynauds syndrome, and symptoms that look like rheumatoid arthritis, but a rheumatologist tested my blood and it was negative for this condition. The swelling comes and goes. Also, gel fracture is a new phenomenon that has been identified for . Plastic surgeon does not know if or when surgical correction can take place. Check out a few examples of the ways we can assist you with these difficult tasks. Experiencing joint pain, chronic fatigue, brain fog, swollen lymph nodes after mammogram. MENTOR MemoryGel Breast Implants are offered in many sizes and profiles: Moderate Plus, High Profile, Ultra High Profile, Moderate Plus Xtra and High Profile Xtra. a few months later things went downhill fast! Adjunct Study Final Report for Mentor's MemoryGel Silicone GelFilled Breast Implants, 02 November 2012. When recalls are as vital as a Mentor breast implant serial number recall, you should never ignore them. 325 0 obj <>/Filter/FlateDecode/ID[<4FD22ED3B7DCE845A6E6AEF3AE0F309B>]/Index[304 37]/Info 303 0 R/Length 103/Prev 225431/Root 305 0 R/Size 341/Type/XRef/W[1 3 1]>>stream H\Pj0+tlI 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. The rheumatologist took blood tests and results showed i had an autoimmune disease known as scleroderma. By this time, too, i began feeling malaise, and i then was weakened to the point of being unable to walk unaided. After being implanted with silicone breast implants (cohesive gel by mentor) i became incredibly sick and my body started having a six-year downward spiral of auto-immune issues, endocrine issues, and adrenal dysfunction. In the event of an unexpected qualifying deflation of a MENTOR Saline-filled Breast Implant, Mentor will replace the product, free of charge, for the lifetime of the patient. I started having serious difficulty breathing at all times, and especially when laying down at night. Implant provides the natural feel patients desire with increased form stability to shape the breast. Don't let time and effort get in the way of taking advantage of getting what you need or are owed. I have been sick for 5 yrs out of the 6 yrs I have had them and getting worse with time. Link. This past year has been the worst so far and i just explanted without replacing the implants because i am 100% certain they have been poisoning me and i am disgusted how the medical industry does not take these type of complaints seriously. Shoulder and neck pain, pain under my rt rib. Link. I have seen 10 doctors over the past 3 years and i have been able to manage, but most of my symptoms remain at large. Choose whether you want a refund, repair, or replacement. Here are all the ongoing symptoms: migraines, anxiety, fatigue, temperature intolerance, sensitivity to smells, burning pain in breasts, inflammation in breasts, weakness, chronic back pain, whole body dryness, pigment discoloration, blurred vision, word retrieval, concentration, and rapid weight gain. I had the implants removed at the end of 2015. 6. Focus Group Study: This study used 35 women to evaluate how patients understood the safety and labeling brochures. So, i had the surgery to replace them and it was an absolute breeze! No tear or rupture was noted over the years so doctors did not know was diagnosed with lupus in 2015 and have been on thousands of dollars worth of medication the whole time. Finally, the FDA released updated information on the status of breast implant manufacturer post-approval studies. Mentor MemoryGel (Premarket application number: P030053) (Approved November 2006) Description and Detailed Information Links: Mentor's MemoryGel Silicone-Filled Breast Implants have a. endstream endobj 310 0 obj <>stream Two major issues, deformity and a rare autoimmune disease seen in much older adults. I am ashamed of the mentor company because of the old and new medical research the proves these implants ar highly toxic. Believe my silicone breast implant was ruptured after a mammogram. I have learned that the mentor company product was approved but was supposed to complete a 10 year study that has now been cancelled. endstream endobj 311 0 obj <>stream 10. No further information was obtained. Link. 39: I have hot and cold sensitivities. I was able to return to a mostly normal life, although the symptoms never went away. No money and insurance will not cover? Link. **1 y* One weekend in early 2014, i took a severe turn for the worse. In (b)(6) 2014, both ruptured implants, damaged lymph nodes, affected chest muscle, and surrounding tissue (to my chest wall) were removed during a 7 hour surgery. Developed anxiety and uncontrolled vaso-vagal responses. I have constant infections. I am tired all the time despite excellent diet and plenty of exercise. Patient also had delayed wound healing, infection, lymphadenopathy on the left side. Could barely walk. I started seeking help starting with my gyn doctor who diagnosed hypothyroid at my yearly visit. Link. There is original labeling (at the time the FDA approved the implant) and current labeling that is updated with post approval study information and to adequately communicate the risks. My body couldnt sweat couldnt get rid of toxins. Brain fog, dizzy, memory loss, nausea, seizures, blurred vision. So many women are sick and get better after explant. Weekly b12 injections. (Unknown if it is Mentor saline or silicone). Rx meds: i guess i will list all that are prescribed many i have not able to take because sadly i cannot afford them anymore. * In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. I had follow-ups with my surgeon and everything seemed to be fine but the symptoms continue to become worse and more frequent. It was reported that a (b)(6) female patient with history of breast prosthesis implantations was diagnosed with left breast cancer. I went to the er, where they werent sure what was wrong and gave me antibiotics, which had no effect. The FDA issued final guidance, Breast Implants - Certain Labeling Recommendations to Improve Patient Communication in September 2020. 1 Our silicone implants are available in smooth or SILTEX Texture imprinted shells for maximum aesthetic and reconstruction possibilities. 350-2250. Scroll down for a list of symptoms women have reported to the FDA and for reports of mastectomy and reconstruction cases, fungus, body parts removed, manufacturer issues, BIA-ALCL, other cancers, and pre and post approval study follow-up. Not even a year later i am so ill and in pain i need three surgeries which will not reverse all thats happened. Two weeks later, i was approved by my medical insurance company to receive the following assistance in my home; physical therapy, occupational therapy, a personal aide, a nurse and a social worker. The recall came after the FDA released data in 2019. 350-2325. Link. I only left the house for doctor appointments. 10. Patient took advil, various muscle relaxants, heat and other remedies. Ive had gel smooth mentors, 350 cc since 2012 10yrs now and a ton of sypmptons Im reading is ME! Swollen hands, tingling in the hands and arms when i bend my joints. 2. 350-1660, SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT W/DIAPHRAGM VALVE, 350-2200 Have had blood tests where discovered i had thyroid issues and then found out i had hashimoto. In 2012 while leaning over the side of tub, i heard a pop, experienced a sharp shooting pain that went straight thru my left breast. I just explained and am getting my health back. To be able to walk and have energy again, and hopefully for the arthritis symptoms to diminish. I was also diagnosed with lower back osteoarthritis and in (b)(6) with fibro. Link. They admitted me and performed exploratory surgery, found I had a ruptured right fallopian tube, which they removed. But since the surgery i feel like my lymph nodes are constantly swollen and keep struggling to fight off infections and colds. hXmo7+br@/M`I8]pqa#yb;7`FERH=:Z+3)5Ii-2ZLyA I immediately felt relief in my joints and muscles as soon as they were removed. Toxic shock symptoms, corrective tissue disease, vision issues, headaches, nose bleeds, recurring pneumonia. I got breast implants in (b)(6) 2011 within weeks i began feeling aches, pains, fevers, chills, racing heart, hair falling out. Mris of brain to check for memory related causes were inconclusive. DoNotPay can assist you with a simple, easy-to-use process in one place. Less than 6 months after having these implants, i started to develop multiple symptoms. A sponsors failure to comply with any post-approval requirement may be grounds for withdrawing approval. FDA. This somewhat lessened some of my symptoms but i still felt sick like i was dying slowly. Bilateral breast pain from breast implants. Link. Ive been to the doctor many times complaining about the lymph gland being swollen and getting dismissed repeatedly, i could really use to use some advice or support. Additional xrays and a great deal of blood work to determine arthritis issues which seem to be taking over my body (was diagnosed as rheumatoid arthritis, but medications have not helped reduce the issues it causes. Spent a lot of money only to learn my implants made me sick i was diagnosed with fibromyalgia and hashimotos along with just guesses of what could be wrong. I have this implant, I had it 4/2017. Site of lymphoma: right side. . Posting Date. Since that day ive suffered the following abnormal weight gain, chronic fatigue, brain fog, diagnosed thrush, lack of energy, dry eyes, lack of concentration, dizziness, inflammation, dry skin and hair, estrogen imbalance. The FDA had required this study to be done for 10 years, according to guidelines of the Approval Order in 2006, but the Final Reportwas submitted in year 6 of the study in 2012. 12. Link. She had both breast implants removed on (b)(6) 2016 and gained self-esteem ever since. i no longer had shortness of breath. Approx 7 years ago, i had a breast augmentation done, re-done actually. In 2006, contacted my plastic surgeon and was told fda had approved a silicone implant for breast cancer patients, so i met with a mentor representative that explained the study i would be required to participate in if i chose these specific implants. Shame on the implant companies, shame on the FDA and shame on doctors who dont give you enough information!!!!!! (Unknown if it is Mentor saline or silicone). Link. 350-3330 I had mris to check for issues with neck- diagnosed at first as herniated discs but then as arthritis. April 2013. of Irving Texas initiated a recall of their MemoryGel breast implants on July 01, 2016, due to a labeling mix-up Consignees were notified by mail and a follow-up visit by a sales representative Recall terminated December 9, 2016 Symptoms and Side Effects of Defective Breast Implants I have chronic widespread pain and digestive trouble. Irvine, Calif., (January 13, 2021) - Mentor Worldwide LLC, the number one global brand in breast aesthetics, and part of . endstream endobj 309 0 obj <>stream Learn how. Within 3 hours of the mammogram i felt very ill, and had hives on my torso. This implants are taking my life away . Heart palpitation, swollen and tender lymph nodes in breast area, underarm, throat, burning sensation around breast implant and arm pit, bladder pressure pain. Had breast augmentation in (b)(6) 2013. (Unknown if it is Mentor saline or silicone). These issues impact daily. endstream endobj 312 0 obj <>stream During the last few years, ive had a swollen lymph gland underneath my right arm that repeatedly i was told was benign and nothing to worry about. The patient felt discomfort which she had not previously experienced. I was able to have a visiting nun come once a week also. Link. Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. Pain is intense, particularly in the mornings or after sitting for a while. 200 cc both sides b cup to c cup. I had silicone gel breast implants placed under the muscle. On October 27, 2021, the FDA took several new actions to strengthen breast implant risk communication and help those who are considering breast implants make informed decisions. 2 5 years, she began to suffer from serious health issues, including but not limited to, constant headaches, difficulty with concentration and focusing, constant pain and swelling in left breast, high anxiety, shoulder and neck pain, obsessive compulsive disorder, muscle weakness, symptoms that resembled fibromyalgia, insomnia, memory issues and other symptoms resembling chronic fatigue syndrome. Released from hospital after 5 days. I was in extreme pain, and i began losing my hair. 13. I also had low levels of magnesium, vit d, zinc and other minerals as well, has fluctuations of female hormones. Link. This began to get out of hand this (b)(6) and i began to research to figure out what was going on. Had breast implants put in and have had failing health since. I then began to have swollen fingers, hands and wrists in (b)(6) of the same year, which led to my being diagnosed with carpel tunnel syndrome by a rheumatologist. Link. Link. I am ASAP to get my life back! I had silicone breast implants and had no idea they both got ruptured. I did not smoke, do not use drugs, do not consume alcohol and eat very clean. All rights reserved. I was a 34 B previously. I was given iv cipro for several days. f1NW 340 0 obj <>stream q@8mhD";BN"z\h[-1k90p UpK&uEO`W4]76 $gQsB#ZYWG[1!EMd[O'teY3c[UhgE?_u `6 Link. You should hear back from the company directly with confirmation and how they will issue the refund or replacement. Epidurals and physical therapy for years. After breast cancer reconstruction. Something needs to happen you have dropped the ball on this. After gathering all of the relevant information concerning the Mentor saline implants recall, you can begin to take the first steps in making your claim. Initiating a recall claim for a Mentor implants recall can be a stressful process on top of what is already a stressful situation. Mri report ((b)(6) 2017) cites patient had augmentation revision procedure in 2008 (no further information stated; no information on types or brand of implants used). Implants should be taken off the market, they are so hazardous to our health. If you are tired of researching online for information or are experiencing difficulty reaching the medical organization responsible for your surgery, you can use DoNotPay's Product Recalls service. MentorMemoryShape, MemoryGel, and Memory Gel BOOST implants are recommended for augmentation patients who are at least 22 years old, while the saline breast implants are indicated for patients who are 18 years and older. Difficulty healing (wound etc. ) Cold feet, swollen tongue, sore breast, migraines/throw up, perioral dermitis, weight gain. Since this event involves device sterility and could have led to an adverse event or serious injury, it is considered serious and mdr reportable. The new ones that suppose to be fda approved and safe ones. I feel my breasts are ruined forever now. I have a supportive husband and family and have even resigned from my teaching position to help figure out my medical issues. No harm came to the patient. The patient believes that the discoloration is a fungus growth inside the right device. I was told these implants were inert and safe for implantation and that was clearly not the case for me. I am being treated for this currently. Tell us how you found out about the recall. My medical bills from this are near (b)(6) and its just not right. Do your research ladies, get a $$ loan if you have to, your health is worth it! 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