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Mentor Important Safety Information & Latest Updates
Mentor Important Safety Information & Latest Updates
At Mentor, we are committed to ensuring every woman has a full understanding of both benefits and risks before deciding to undergo surgery for breast implants. The important safety information you and your patients should discuss prior-to surgery are available in the digital brochures and pamphlets below.
In addition to what is included in the documents, it’s important that you know the following safety updates:
- Patients who undergo breast implant surgery with connective tissue diseases (CTD) may experience an increased risk of wound dehiscence, infection and bleeding (likely due to their ongoing medical management) that may require further treatment.
- Some patients with breast implants have reported experiences of neurological and/or rheumatological diseases. Mentor is currently collecting data to further understand these potential risks and their possible association with breast implants.
Based on information reported to global regulatory agencies and found in medical literature, an association has been identified between breast implants and the development of anaplastic large cell lymphoma (ALCL), a type of non-Hodgkin’s lymphoma. Women with breast implants have a very small but increased risk of developing Breast Implant Associated ALCL (BIA-ALCL) in the fluid or scar capsule adjacent to the implant, with documented potential for local, regional, and distant spread of the cancer with mortality reported in rare cases. BIA-ALCL has been reported globally in patients with an implant history that includes Mentor’s and other manufacturers’ breast implants with various surface properties, styles, and shapes. Most of the cases in the literature reports describe a history of the use of textured implants. Several journal articles explore the risk factors for BIA-ALCL, including the varied methods used to create surface texture of the implant and the role of biofilm in causing disease, among others.
You should consider the possibility of BIA-ALCL when a patient presents with a late onset seroma (at least 1 year and on average 7 to 10 years following implantation), breast mass adjacent to the implant capsule or lymphadenopathy. Work-up of delayed enlargement of a previously implanted breast includes an ultrasound or MRI to look for the presence of seroma or lymphoma, Diagnosis starts at presentation, with needle aspiration of as much of the fluid as possible (minimum 50 mL), using ultrasound for implant displacement and protection. A suspicious mass requires needle or open tissue biopsy. Specimens should be sent for cell morphology by cytology, CD30 immunohistochemistry and ALK (anaplastic lymphoma kinase), and flow cytometry for evaluation, quantification, and characterization of T cells within the specimen. Hematopathology consultation at a tertiary cancer center is strongly encouraged to establish or exclude a diagnosis of BIA-ALCL. Once the diagnosis of BIA-ALCL has been established, physicians are strongly encouraged to consult with a multidisciplinary team including oncologists, pathologists, surgical oncologists, and plastic surgeons. The United States National Comprehensive Cancer Network (NCCN) guidelines for treatment of established BIA ALCL includes the removal of the implant and the entire surrounding implant capsule in addition to associated masses and lymph node involvement.
FDA provides additional information regarding questions and answers for BIA-ALCL, please visit:http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm
Please note for latest diagnostic and treatment options refer The National Comprehensive Cancer Network (NCCN) guidelines
We will continue to share the most up-to-date safety information on this website and recommend you check in periodically to ensure you have the latest safety information available.
Disclaimer: The links beyond this webpage may contain promotional materials, that in countries where direct promotional advertising is not allowed is addressed only to Health Care Professionals (HCPs).
Links to Digital Brochures and Pamphlets
Gel Breast Implants (Applicable to Round Gel and CPG):
Product Insert Data Sheet Multi-Lang Insert (EN, DE, FR, PT EU, PT Brazil, ES EU, IT, NL, SV, DA, PL, EL, TR, RU, ZH, KO, TH)
100069598 | Rev:7 (156001-04)
IFU Multi-Lang Outsert (NO, FI, ET, LT, LV, CS, SK, SL, HU, RO, BG, UK, HR, SR, SQ, MK)
100079298 Rev:7 (156002-05)
CPX™4 Breast Tissue Expander:
- CPX™4 OUS textured (Eastern Europe IFU)
- CPX™4 OUS Textured (English IFU)
- CPX™4 OUS Textured (Western Europe)
Becker Expander/Breast Implants:
IFU Multi-Lang (EN, DE, FR, PT EU, PT Brazil, ES EU, ES Mexico, IT, NL, SV, DA, PL, EL, TR, RU, JA, ZH)
10069597 Rev 5 (156000-03)
IFU Multi-Lang Outsert (NO, CS, HU, SL, SK, RO, LT, LV, ET, FI, UA, BG, HR, SR)
100069603 Rev 5 (156005-03)
IFU Multi-Lang Insert (EN, DE, FR, IT, ES, ES Mexico, PT EU, PT Brazil, NL, SE, DK, NO, GR, CZ, HU, PL, SK, SI, RO, LT, LV, JP, KR, TH, CN, TR, BG, EE, FI, RU, UA, HR, RS)
1000696624 Rev 5 (159798-01)
Additional Patient Information:
GEL-FILLED BREAST IMPLANT SURGERY "Making an Informed Decision" Patient Brochure (EN, DE, FR, ES, IT, PT, DA, SV, EL, NO, PL, CS, HU, LV, LT, RO, SK, ET, BG, FI, IS, SL, NL, HR, SR)
100069444 Rev 4 (10647-03)
MentorPromise Protection Plan: