Frequent migraines with vomiting extreme fatigue hair loss blurred vision acting joints right arm-numbness and pain 20 pound weight gain and bloating of abd and frequent heartburn, brain fog with memory loss and difficulty focusing anxiety and flat affect cold intolerance esp hands and feet. After doing research on my own and some common sense. Smooth surfaced implants are not affected by this recall. The … Maintain awareness of this notice until all units from lot number 7377332 in your inventory have been returned. This is the softest gel and has been preferred for years in textured and smooth Round Low, Moderate, Moderate Plus, High, and Ultra Instructions for Downloading Viewers and Players. Recall Status 1: Terminated 3 on June 13, 2017: Recall Number: Z-2070-2017: Recall Event ID: 76868: PMA Number: P990075 : Product Classification: Prosthesis, breast, inflatable, internal, saline … If you notice any changes in your breasts or have concerns, contact your health care provider. **As compared to saline-filled breast implants. are Biocell products including: Natrelle saline-filled breast implants, Natrelle silicone-filled breast implants… Allergan’s July 2019 Biocell textured breast implant recall doesn’t include its smooth or Microcell breast implants or tissue expanders, which have a much smaller risk of BIA-ALCL. I will be one month post-op on Monday, 11/5 from my breast augmentation. Note: If you need help accessing information in different file formats, see Silicone implants currently available in the United States include fourth- and fifth-generation devices from three manufacturers, Sientra (Santa Barbara, CA), Allergan (Irvine, CA), and Mentor (Irvine, CA). 100316549 3D Benchtop Imaging of Artoura and Allergan Completion Report . Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English, Prosthesis, breast, inflatable, internal, saline, Code of Federal Regulations (CFR) Title 21 §7.55, PMAs with Product Code = FWM and Original Applicant = MENTOR WORLDWIDE LLC, Instructions for Downloading Viewers and Players, Class 2 Device Recall SalineFilled SPECTRUM Breast Implants. Immediately after, she suffered from: joint and muscle pain, neuro-cognitive changes, chronic … Two Florida women filed a $5 Million dollar lawsuit against Allergan as a result of the recall. I obtained a family doctor at this point who subscribed thyroid meds and followed me with maintaining therapeutic tsh levels. The FDA has not released the exact number of implants affected. Allergan patient labeling (current) Patient labeling for Inamed (now Allergan) saline breast implants (2004) (PDF - 2.73MB) On (b)(6) 2002, pt stated she was implanted with mentor smooth saline breast implants during reconstructive surgery at the age of (b)(6). In 2019, several types of Allergan breast implants were recalled by the Food and Drug Administration (FDA) over a risk of cancer. Hi there. Mentor ALSO did not follow through with the 10yr protocol advised by the FDA per their PMA introduced in 1999 for saline smooth round implants. 27 March 2020. I have HP Mentor smooth round silicone implants placed under the muscle, inframammory incisions. We apologize for any inconvenience this may cause. Both implants are 375 CCs, and I went from a 34A to a 36C/34D. Thank you for your attention and cooperation. I also had low levels of magnesium, vit d, zinc and other minerals as well, has fluctuations of female hormones. Allergan’s July 2019 Biocell textured breast implant recall doesn’t include its smooth or Microcell breast implants or tissue expanders, which have a much smaller risk of BIA-ALCL. Immediately after removing the implants began seeing a new dr for help with this who after further lab studies diagnosed me with hashimoto's thyroiditis which is an autoimmune disease more than likely caused by the endocrine disruptive toxins in the implants. Style 2000: l Smooth Round Moderate Plus Profile; Style 3000: l Smooth Round High Profile (chart below) The smooth, round saline implant offers a smooth surface shell and an anterior, self-sealing, diaphragm valve. Mentor stands confidently behind the safety and quality of the products we supply, and we appreciate your cooperation in this matter. Each implant is filled with the Mentor proprietary cohesive gel that holds together uniformly and retains a … Updated on June 30, 2016 The most commonly used saline implant is a round, smooth implant. Mentor stands by its textured implants and says the cancer is "rare" with its product. *As compared to Allergan 133MV-13 and 133MX-13 in a benchtop study under simulated compression 1. Smooth implants are used more often than … This somewhat lessened some of my symptoms but i still felt sick like i was dying slowly. Many women who have mastectomy to treat breast cancer go on to have one or both breasts reconstructed. Please know the U.S. Food and Drug Administration (FDA) has been notified of this voluntary field action. Once placed, the implant is filled to the predetermined size. 750cc Mentor Memory Gel Breast Implant, Smooth Round High Profile [REF]350-7504BC [SN]7619207-033 & -032. Cohesive I™ The standard cohesive level gel used in MENTOR® Breast Implants. Left breast is … Meanwhile, Mentor said its study of 1,680 saline implant recipients found that up to 27% of the implants were removed within three years, mostly due to infections, pain, or leaking. The recalled breast implants represent less than 5 percent of implants sold in the United States. If you already have breast implants, the FDA advises you to continue your regular, routine medical care and follow-up. 2 The current breakdown of breast implant usage in the United States is approximately 87% smooth and 13% textured. Many women who have mastectomy to treat breast cancer go on to have one or both breasts reconstructed. Mentor stands by its textured implants and says the cancer is "rare" with its product. As soon as 4 months after implantation i had an emergent visit … I am very healthy, physically, mentally, emotionally, typically. If a saline implant ruptures, the body will naturally absorb the liquid, and the implant will collapse. Both implants are 375 CCs, and I went from a 34A to a 36C/34D. The Future of Mentor Breast Implant Lawsuits I will be one month post-op on Monday, 11/5 from my breast augmentation. Smooth surfaced implants are not affected by this recall. For further questions please call (972) 252-6060. Your complete guide to recalls, "breast implant illness," and the ... Greene got her first implants at age 21. Contour Profile® (Anatomical / Teardrop) Saline Breast Implants … Saline implants are FDA-approved for augmentation in … If you have any questions related to this notice, please contact your local Mentor Sales Representative or Mentor Customer Service at 1-800-235-5731. I have HP Mentor smooth round silicone implants placed under the muscle, inframammory incisions. AccessGUDID - MENTOR Smooth Round Moderate Plus Profile (00081317001478)- Saline Breast Implant with Diaphragm Valve, 500cc Immediately identify all unused units and return them to Mentor per the normal return process.Forward this notice to anyone in your facility that needs to be informed. All MENTOR® Silicone Gel-Filled Breast Implants contain gel that is cohesive, safe and aesthetically pleasing. Saline has the firmest feel and a number of options for volume, shape and projection. Two Florida women filed a $5 Million dollar lawsuit against Allergan as a result of the recall. Smooth Round Moderate Plus Profile (Mentor Style 2000). As time went on symptoms worsened with high blood pressure headaches with vomiting more frequent causing me to miss work excessive thirst, urinary urgency and changes in menstrual cycle neck pain. FDA Documents: Approval Date: November 17th, 2006 Recalls FDA Overview – Mentor MemoryGel […] As soon as 4 months after implantation i had an emergent visit to the er for "vertigo" persistent vomiting and dizziness. MENTOR ® MemoryGel ® Breast Implants provide the soft, natural feel patients desire and are available in a wide range of sizes and profiles to fit the patient’s body. Note: If you need help accessing information in different file formats, see If you check the FDA data base for PMS…there is none. Mentor MemoryGel Silicone Breast Implants: 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. Mentor® CPX™4 with Suture Tabs Breast Tissue Expander: Conditions imposed* 110587: Smooth Round Cohesive I: Conditions imposed: 119646: Smooth Saline Mammary Prostheses with Diaphragm Valve: Conditions imposed: 319150: Smooth Round XTRA Gel Breast Implants: Conditions imposed: 326144: Siltex Round XTRA Gel Breast Implants: Conditions imposed Breast Implant Sizes and Types Mentor Round Saline Breast Implants. A breast implant made by Mentor, one of two implant manufacturers that the F.D.A. A lot of my symptoms have improved or disappeared after removing the implants. MENTOR ® Saline-Filled Breast Implants are inflated to the desired size with sterile isotonic saline before implantation, as well as postimplantation. Up until getting implants i never had any significant health problems. There are two ways to reconstruct a breast: 1. using tissue transplanted from another part of your body (such as your back, belly, or thighs) 2. inserting an implant that's filled with saline (salt water) or silicone gelA saline implant has a silicone shell that is filled with saline. I am reporting now in the hopes that eventually these implants will be removed from the market and further restrictions imposed on any implantable device put in the human body. Since February 1, 2017, the FDA received 359 reports of cancer associated with the implants and women are now considering whether they should file breast implant lawsuits. I had the breast implants removed on (b)(6) 2015 and began the process of detoxing the chemicals and heavy metals that are in silicone gel breast implants. In 2019, several types of Allergan breast implants were recalled by the Food and Drug Administration (FDA) over a risk of cancer. I was told these implants were inert and safe for implantation and that was clearly not the case for me. 1 The recalled products are: Allergan Natrelle Saline-Filled Breast Implants (formerly McGhan RTV Saline-Filled Mammary Implant) approved under P990074. I have good days and bad days and my life has forever been impacted after having these poison bags put in my body. 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). The recalled devices listed by the F.D.A. Mentor Saline Implants. Learn how. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English, Autoimmune Disorder (1732); Fatigue (1849); Micturition Urgency (1871); Hair Loss (1877); Headache (1880); High Blood Pressure/ Hypertension (1908); Memory Loss/Impairment (1958); Swelling (2091); Vertigo (2134); Blurred Vision (2137); Vomiting (2144); Dizziness (2194); Anxiety (2328); Numbness (2415); Confusion/ Disorientation (2553); Polydipsia (2604); Weight Changes (2607); No Code Available (3191), Instructions for Downloading Viewers and Players, SMOOTH ROUND HIGH PROFILE GEL BREAST IMPLANT, MAGNESIUM; NATURE-THROID; SELENIUM ; VITEX; ZINC. A correction or removal action taken by a manufacturer to address a problem with a medical device. Since 2011, the FDA has been studying the link between anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin’s lymphoma, and breast implants. Over the next 3 years my health steadily declined with unexplained symptoms. Mentor conducted a 5-year study on reconstruction patients. Silicone gel implants are filled with firm silicone gel. After its implants were first approved by the FDA, Allergan was required to conduct a large, 10-year study of nearly 60,000 participants with gel- and saline-filled implants. Mentor offers three different saline implant profiles with a rounded shape and smooth shell: Moderate, Moderate Plus and High Profile. MENTOR ® MemoryShape ® Breast Implants use a unique cohesive gel that holds together evenly for a smooth, natural silhouette. If you have sent these units to another facility, forward this notice to that facility. Style 1600: Smooth … Structured saline implants also contain salt water, but they also contain an inner structure aimed at making the breast feel more natural. MENTOR ® Saline-Filled Breast Implants can also help reduce the number of surgeries by eliminating the need for separate expanders. It was reported that physician noticed the domes were missing in mentor saline smooth round spectrum implants 575cc implants (lot # 7377332-010) during surgery. ... rule out smooth implants, ... the recalled implants … After its implants were first approved by the FDA, Allergan was required to conduct a large, 10-year study of nearly 60,000 participants with gel- and saline-filled implants. However, i am left with a chronic illness now that most likely will need some medication, supplement, and labs and doctor visits to manage for the rest of my life. I have been performing breast augmentation with implants produced by Allergan or Mentor in my Champaign, Illinois, Cosmetic Plastic Surgery practice for more than 25 years. And some common sense Artoura and Allergan Completion Report this notice to that.. 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