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. is warning about. are Biocell products including: Natrelle saline-filled breast implants, Natrelle silicone-filled breast implants… It was reported that physician noticed the domes were missing in mentor saline smooth round spectrum implants 575cc implants (lot # 7377332-010) during surgery. Actions Requested 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 … ... rule out smooth implants, ... the recalled implants … Home » Breast Implant Sizes » Mentor MemoryGel (Silicone) Smooth Round High Profile Silicone Breast Implant Sizes MemoryGel® (Silicone) High Profile MemoryGel® Breast Implants utilize Mentor’s proprietary cohesive gel formulation that holds together uniformly, creating a … Left breast is … 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. Unfortunately, so many women (almost 60%) dropped out of the study before the five years were completed, that the information is not reliable. 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. Learn how. 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. Your complete guide to recalls, "breast implant illness," and the ... Greene got her first implants at age 21. Cohesive I™ The standard cohesive level gel used in MENTOR® Breast Implants. The FDA has not released the exact number of implants affected. I have HP Mentor smooth round silicone implants placed under the muscle, inframammory incisions. 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. Mentor conducted a 5-year study on reconstruction patients. Two Florida women filed a $5 Million dollar lawsuit against Allergan as a result of the recall. Please know the U.S. Food and Drug Administration (FDA) has been notified of this voluntary field action. Mentor sent an Recall Notification letter dated March 27, 2017 was sent to consignees (hospitals/doctors) . Over the next 3 years my health steadily declined with unexplained symptoms. On (b)(6) 2002, pt stated she was implanted with mentor smooth saline breast implants during reconstructive surgery at the age of (b)(6). Many women who have mastectomy to treat breast cancer go on to have one or both breasts reconstructed. Both implants are 375 CCs, and I went from a 34A to a 36C/34D. By that time the patient was on the table. Many women who have mastectomy to treat breast cancer go on to have one or both breasts reconstructed. If you check the FDA data base for PMS…there is none. Silicone gel implants are filled with firm silicone gel. **As compared to saline-filled breast implants. Immediately after, she suffered from: joint and muscle pain, neuro-cognitive changes, chronic … In 2019, several types of Allergan breast implants were recalled by the Food and Drug Administration (FDA) over a risk of cancer. On the date listed above, i received breast augmentation with mentor smooth round high profile gel (silicone) implanted ref (b)(4), left lot #6528127, sn # (b)(4) and right lot #5950089, sn # (b)(4). Mentor (a Johnson & Johnson company) offers three different FDA-approved types of breast implants that are used for breast augmentation or breast reconstruction after a mastectomy: MemoryShape, MemoryGel, and saline implants. Structured saline implants also contain salt water, but they also contain an inner structure aimed at making the breast feel more natural. I have good days and bad days and my life has forever been impacted after having these poison bags put in my body. Breast Implant Sizes and Types Mentor Round Saline Breast Implants. Saline has the firmest feel and a number of options for volume, shape and projection. The FDA has not released the exact number of implants affected. This case is still ongoing as of November 2019. 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. 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. If you have sent these units to another facility, forward this notice to that facility. The recalled products are: Allergan Natrelle Saline-Filled Breast Implants (formerly McGhan RTV Saline-Filled Mammary Implant) approved under P990074. In 2019, several types of Allergan breast implants were recalled by the Food and Drug Administration (FDA) over a risk of cancer. 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. This is the softest gel and has been preferred for years in textured and smooth Round Low, Moderate, Moderate Plus, High, and Ultra MENTOR ® MemoryShape ® Breast Implants use a unique cohesive gel that holds together evenly for a smooth, natural silhouette. Mentor stands by its textured implants and says the cancer is "rare" with its product. The recall covers all styles of Allergan’s BIOCELL textured breast implants, including both silicone and saline-filled ones. Siltex® Round Moderate Profile (Style 2600) . I started seeking help starting with my gyn doctor who diagnosed hypothyroid at my yearly visit. MENTOR ® Saline-Filled Breast Implants can also help reduce the number of surgeries by eliminating the need for separate expanders. Thank you for your attention and cooperation. When the fill-tube is removed, the implant will automatically seal itself. 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. *As compared to Allergan 133MV-13 and 133MX-13 in a benchtop study under simulated compression 1. Gel-Filled Breast Implant, Mentor will provide a replacement of a MENTOR ... CPG Implants can help achieve a smooth transition from tissue to implant8 FRONT PAGE FINISHES SHORT 3. 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