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If you notice any changes in your breasts or have concerns, contact your health care provider. Maintain awareness of this notice until all units from lot number 7377332 in your inventory have been returned. If you've lost your breast implant ID card, don't panic. What to do if you have a recalled implant. The most common complications with MemoryShape® Implants for breast reconstruction include reoperation for any reason, implant removal with or without replacement, and capsular contracture. The device could be moved by the MRI causing pain or displacement, potentially resulting in a revision surgery. Lot numbers: All lots (for complete listing of all styles, see the FDA Safety Communication) 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. 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. IMPLANT MENTOR. 2 1 Our commitment to you: the highest standard of quality, proven safe and effective clinical outcomes and differentiated service, everyday. Visa® MasterCard® American Express® Discover® You will receive an email verifying your enrollment in the ConfidencePlus® Premier warranty. In addition to the lot number, a unique serial number is also associated with each breast implant. Your medical device card will have all the information you need as to what type of breast implants you have. Many women, however, do not know what types of breast implants they have. Another Way Implant Serial Numbers Have Been Useful. Silicone gel filled breast implants manufactured by Poly Implant Prothese (PIP). Unlike round breast implants, MENTOR ® MemoryShape ® Breast Implants are teardrop shaped, meaning they are thinner at the top and gently slope to a fuller projection point near the implant’s bottom to mimic the silhouette of a natural breast. The recalled breast implants represent less than 5 percent of implants sold in the United States. 88115480. Implant patient registry. Enter Serial Number: Results. For example: 123456 or A123456 Verify UPN/Model Number and Serial or Lot Number. If you notice any changes in your breasts or have concerns, contact your health care provider. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months. 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. Patients with breast implants should confirm whether they have one of the implants or tissue expanders listed on Allergan’s recall announcement. call for free consultation (866) 746-9163. It should also have important information such as the date of your surgery, your physician’s name, the breast implant size and the final fill volume of your implants (if you chose saline). 2018-09-13. STERILE 102929-001 Rev. 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. In the event of a Qualifying Rupture (loss of shell integrity), Mentor will provide replacement of a MENTOR® Product in the same style as the originally implanted product free of charge for the lifetime of the patient. Word Mark. Put this card in a safe place, such as your wallet or a file full of important documents at home. C LAB100054097v3 Effective December 2013 Serial Number. MENTOR is committed to supporting and partnering with you and we provide you the It may have been years since they received the implants. You can request these records from the surgeon's office and/or the surgical facility. breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), even if a doctor has not diagnosed you with cancer, BIA-ALCL | Breast Implant-Associated Anaplastic Large Cell Lymphoma, Removing Recalled Allergan Breast Implants and Financial Help, Cancer Risks With Different Types of Breast Implants. Mark Drawing. The lot number reflects the batch of breast implants (including the filling material) produced at a certain time. The most common complications with MemoryShape® Implants for breast augmentation include reoperation for any reason, implant removal with or without replacement, and ptosis. Mentor saline breast implants in 2001 – over the muscle. 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. Every two years after to detect silent rupture the FDA does not recommend patients symptoms. Fda has not released the exact number of implants affected, it has 2 codes on it ( one each. Six months a Medtronic CRHF device breasts or have concerns, contact health! Identification card that should be kept with you at all times the registry will receive the same type of implants! 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