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The 10-Year GLOW Study
At Mentor, we’re guided by patient safety and science and we work closely with the FDA to continually monitor the performance of our breast implant products. That’s why we’re sponsoring a 10-year post-approval study, and we need your help to collect important data on the long-term performance of both our MemoryShape® and MemoryGel® Breast Implants.
Enrollment in the MemoryShape® Breast Implants Group is Open
If you’re interested in participating in this study, click here to locate and contact a study site near you.
It’s important to know that the cost of the surgery and implants are not covered by the study.
Patients will receive the MENTOR® Enhanced Warranty at no cost and will receive compensation for every annual study questionnaire that is completed. Those who complete questionnaires throughout the 10-year study will receive additional compensation.
We appreciate your commitment to this study and your dedication to ensuring there are safe implant options for women now and in the future.
If you’re considering enrollment, or you’re already enrolled, we’re grateful that your commitment will allow others to find and achieve their glow in the future.
Remember, as a study participant, your personal health information will be kept confidential in accordance with the disclosures you have provided in the study informed consent. Please contact your surgeon to request any of your personal data from your participation in the trial.
Our Commitment to Safety
Nothing is more important to Mentor than the health and satisfaction of the patients who choose our breast implants. We adhere to the highest standards of quality, and the safety and clinical performance of MENTOR® Breast Implants is being continually studied. Our products are sold around the world because of our persisting commitment to providing objective clinical information about breast implant safety to help drive an informed choice and give women results they seek.
We’re proud of the long-standing safety of our implants and, in turn, offer one of the best warranty programs in the industry.1-4
Additionally, each Mentor product undergoes a stringent inspection and rigorous testing to ensure quality and performance. Our process is robust for every product we make—and the process never stops. We closely monitor the clinical performance of MENTOR® Breast Implants through clinical studies, registries and post-market surveillance activities. And we’re constantly evaluating ingredients and materials, and implementing manufacturing innovation based on the latest research and feedback.
Please visit BreastImplantsbyMentor.com for more information on our safety and standards.
Our Commitment to Supporting Breast Implant Surveillance
Glow study investigators are strongly encouraged to submit data to two breast implant registries created and supported in collaboration by the Plastic Surgery Foundation and the FDA.
The National Breast Implant Registry (NBIR) collects clinical, procedural and outcomes data at the time of operation and any subsequent reoperations for all US patients receiving breast implants.
The Patient Registry and Outcomes for breast Implants and anaplastic large cell Lymphoma (ALCL) etiology and Epidemiology (PROFILE) collects retrospective and prospective data on confirmed cases of primary ALCL (including localized or systemic disease, and of any anatomic site and ALCL cell phenotype) in women with breast implants.
1. Mentor Warranty. https://www.breastimplantsbymentor.com/implant-warranties/#MemoryShape-warranty
2. Allergan Warranty. http://www.natrellesurgeon.com/Content/assets/Natrelle_Warranty%20Brochure_DFU. Accessed 04/12/2018.
Sientra Product replacement policy and warranty. http://www.sientra.com/Content/pdfs/Warranty_Terms_And_Conditions.pdf. Accessed 04/12/2018.
3. Sientra CapCon Warranty. http://www.sientra.com/Content/pdfs/CapCon_Care_Program_Terms_ and_Conditions.pdf. Accessed 04/12/2018.
4. Sientra mailing to US Plastic Surgeons