A cancer diagnosis could lead to treatment such as the removal of your breast implants. If not, the surgicenter/facility and surgeon should have a record. You may also notice lumps in your breast or armpit. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months. * 1. (CPG™) Breast Implants and MENTOR® Saline Breast Implants directly from Mentor and implanted in Australia as of 1st March 2016. The FDA has not released the exact number of implants affected. The ARTOURA™ Breast Tissue Expander or CONTOUR PROFILE® Breast Tissue Expander can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision, and tissue defect procedures. MENTOR® MemoryGel® Breast Implants, MENTOR® MemoryShape® Breast Implants, and MENTOR® Saline-filled Breast Implants are indicated for breast augmentation in women (at least 22 years old for MemoryGel® Implants and MemoryShape® Implants, and 18 years old for Saline Implants) or for breast reconstruction. This tool will provide results only for current CRHF implantable IPG, ICD and CRT devices and leads. Problem. 2 1 Our commitment to you: the highest standard of quality, proven safe and effective clinical outcomes and differentiated service, everyday. If you've lost your breast implant ID card, don't panic. If you notice any changes in your breasts or have concerns, contact your health care provider. IMPLANT MENTOR. MENTOR® Breast Expanders. Mentor Saline-Filled Breast Implants – FDA Information 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. You can request these records from the surgeon's office and/or the surgical facility. Patients who enroll in the registry will receive an identification card that should be kept with you at all times. The hospital should be able to tell you the manufacturer and model number of your breast implants, as well as send you a copy of your medical records. Put this card in a safe place, such as your wallet or a file full of important documents at home. After receiving your permanent breast implants, your doctor will give you a small card (shaped like a credit card). Mark Drawing. Before you call technical support, you should locate the serial number on your Baha® 5 SuperPower Sound Processor. Learn More: MENTOR Breast Expanders The Food and Drug Administration (FDA) recently announced a recall on Allergan textured breast implants as a precaution against breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). FDA Documents: Approval Date: May 10th, 2000 Medical Device Recall Search FDA Overview – Saline Breast […] You might also look through your records and see if you still have the original information about your implants. You will receive the same type of card after the implantation of any medical device, such as a hip or knee replacement. Status: 602 - Abandoned-Failure To Respond Or Late Response. If it has been years since you received your breast implants and you no longer have your device card, contact your doctor to ask about your medical records. Copyright © 2021 breastimplantrecalllawyer.com. In addition to the lot number, a unique serial number is also associated with each breast implant. It is intended to assist healthcare professionals in determining if an implanted system is MR Conditional. © Mentor Worldwide LLC 2021 049328-160315, 049328-170419, 084025-171211. The manufacturer of the other 20 patients’ implants is not known. The health consequences of a ruptured silicone gel breast implant have not been fully established. What to do if you lost your breast implant ID card. call for free consultation (866) 746-9163. It may have been years since they received the implants. Put this card in a safe place, such as your wallet or a file full of important documents at home. MENTOR ® MemoryShape ® Breast Implants shape the breast and have a unique, tapered appearance. Should a confirmed rupture or deflation occur, the patient will receive up to two replacement breast implants of the same style or like style at no additional charge for the lifetime of the patient. STERILE 102929-001 Rev. Patients who enroll in the registry will receive an identification card that should be kept with you at all times. MENTOR ® MemoryGel ® Breast Implants, MENTOR ® MemoryShape ® Breast Implants, and MENTOR ® Saline-filled Breast Implants are indicated for breast augmentation in women (at least 22 years old for MemoryGel ® Implants and MemoryShape ® Implants, and 18 years old for Saline Implants) or for breast reconstruction. MENTOR is committed to supporting and partnering with you and we provide you the Mentor Texas, LP. This field is for validation purposes and should be left unchanged. FDA Determined Cause 2: Labeling mix-ups: Action TX 75057, Attn: Allergan Device Analysis Laboratory with contact information, serial number(s) and reason for return. Choosing implants for breast augmentation or reconstruction after mastectomy should not unreasonably put your life at risk. We do not recognize this serial number as a Medtronic CRHF device. Device Lookup Tool Learn if a specific device is affected by a current product advisory issued to physicians by Boston Scientific Cardiac Rhythm Management. AccessGUDID - MENTOR MemoryGel Breast Implant (00081317000815)- SILTEX Round Moderate Plus Profile Gel-Filled Breast Implant, 175cc For MemoryShape® Implants, patients should receive a copy of Patient Educational Brochure – Breast Augmentation with MENTOR® MemoryShape® Breast Implants or Patient Educational Brochure – Breast Reconstruction with MENTOR® MemoryShape® Breast Implants, and a copy of Quick Facts about Breast Augmentation & Reconstruction with MENTOR® MemoryShape® Breast Implants. C LAB100054097v3 Effective December 2013 Implant patient registry. Dadarrio's implants were manufactured by the company Mentor. Call the surgical center where you received your breast implants if you do not remember the name of your plastic surgeon. Your medical device card will have all the information you need as to what type of breast implants you have. If you already have breast implants, the FDA advises you to continue your regular, routine medical care and follow-up. Used in breast reconstruction, breast expanders are designed to expand the lower portion of a breast, so the resulting pocket will accommodate an implant. MENTOR ® MemoryGel ® Breast Implants, MENTOR ® MemoryShape ® Breast Implants, and MENTOR ® Saline-filled Breast Implants are indicated for breast augmentation in women (at least 22 years old for MemoryGel ® Implants and MemoryShape ® Implants, and 18 years old for Saline Implants) or for breast reconstruction. Many women, however, do not know what types of breast implants they have. The most common complications with MENTOR® Saline-filled Implants include reoperation, implant removal, capsular contracture, breast pain, and implant deflation. Many surgeons put the serial number and other important data in the operative report as well. For MENTOR® Saline-filled Implants, patients should receive a copy of Saline-Filled Breast Implants: Making an Informed Decision. Each implant is filled with the Mentor proprietary cohesive gel that holds together uniformly and retains a natural give that better resembles breast tissue. Serial Number Lookup. 16-0740-160414 Nordic Mentor Implant Catalogue. Event Number Z-2326-2016 Event Initiated Date 2016-07-01 ... Model / Serial 7316994 Product Classification ... CA, TX, CO, NC, NJ, OH, TN, RI, and IL. What to do if you have a recalled implant. Product Description Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. Contact us today for assistance with breast implant identification and other tasks. 1-800-MENTOR8 (800-636-8678) Monday-Friday 8 a.m. – 5 p.m. PST Visa® MasterCard® American Express® Discover® You will receive an email verifying your enrollment in the ConfidencePlus® Premier warranty. A product liability claim against Allergan may ultimately result in payment for your economic and noneconomic damages as a patient with recalled breast implants or tissue expanders – even if a doctor has not diagnosed you with cancer. 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. This tool may also be used on an as needed basis to check to see if an affected device is within scope of a current product removal for non-Cardiac Rhythm Management devices. Device. Another Way Implant Serial Numbers Have Been Useful. Another set of identifying stickers will be sent to the implant manufacturer, along with your social security number and information about your surgery. FDA Documents: Approval Date: May 10th, 2000 Medical Device Recall Search FDA Overview – Saline Breast […] If you find out you have one of the implant types listed on Allergan’s voluntary recall, contact our attorneys for advice on what to do next. Symptoms may include swelling or an excessive buildup of fluid in your breasts, and/or chronic pain. FDA Determined Cause 2: Labeling mix-ups: Action The recalled breast implants represent less than 5 percent of implants sold in the United States. The most common complications with MemoryShape® Implants for breast reconstruction include reoperation for any reason, implant removal with or without replacement, and capsular contracture. Even without a BIA-ALCL diagnosis, an attorney could help you find out if Allergan may pay for your corrective procedures in light of the global recall. Mammograms for Women With Breast Implants. Every breast implant has a lot number and a serial number associated with it. III. Click here to learn how. Yet with links to cancer, some Allergan breast implants and tissue expanders may put patients at serious risk of developing a deadly type of lymphoma. IMPLANT MENTOR - Trademark Details. All Rights Reserved. Product Description Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. Implant patient registry. We can help you investigate your implants and fight for justice. If you already have breast implants, the FDA advises you to continue your regular, routine medical care and follow-up. Enter Serial Number: Results. 3025 Skyway Cir N Irving TX 75038-3524: For Additional Information Contact: Customer Service 800-235-5731 Manufacturer Reason for Recall: The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates. The lot number reflects the batch of breast implants (including the filling material) produced at a certain time. A lower risk of complication is rupture. Word Mark. If implant rupture is noted on an MRI, you should have the implant removed, with or without replacement. Mentor stands confidently behind the safety and quality of the products we supply, and we appreciate your cooperation in this matter. If not, the surgicenter/facility and surgeon should have a record. You should have received an implant card or other record of your implant model and serial numbers. All models and lot numbers. It will have the name of the implant manufacturer, as well as the device serial number and model number. The incidence of extrusion of the expander has been shown to increase when the expander has been placed in injured areas. Enter the Serial or Lot Number exactly as it appears on your Device ID card or in product labeling. Put this card in a safe place, such as your wallet or a file full of important documents at home. She is one of a growing number of women being diagnosed with the rare disease known as Breast Implant … Edwards Lifesciences maintains a registry of patients who have received Edwards implantable devices.
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