Here, Alenka Brzulja, Worldwide President of Mentor Worldwide LLC at Johnson & Johnson MedTech, discusses the development and FDA approval of MemoryGel™ Enhance Breast Implants. Designed for breast reconstruction patients needing larger volume options, the implants mark a major advancement in breast aesthetics. Brzulja highlights the product’s driving force, insights from the ATHENA study, and plans for its U.S. launch in mid-2025.
Plastic Surgery Practice: What was the driving force behind developing the MemoryGel Enhance Breast Implants, particularly the focus on larger volume options?
Alenka Brzulja: Simply put, an unmet patient need. The development of MemoryGel Enhance reflects our unwavering commitment to meaningful innovation, bringing a product to market that addresses the diverse needs of breast reconstruction patients. For years, women with larger cup sizes undergoing breast reconstruction had limited options, as the largest implant available was 800cc—an option that didn’t meet the needs for all body types or reconstruction goals.
MemoryGel Enhance was specifically designed to bridge this gap by offering a line of implants that were larger than 800cc, providing a critical solution for women needing greater volume restoration after a mastectomy. Larger volume implants are essential for delivering the proportional outcomes these patients deserve. We want to support women at every stage of their journey by continually pushing the boundaries of what’s possible in breast aesthetics and reconstruction.
PSP: How do the new implant sizes align with the unmet needs of patients and surgeons in breast reconstruction post-mastectomy?
Brzulja: Breast reconstruction is an inherently personal journey, with every patient bringing her unique anatomy, preferences, and goals. With over 150,000 women in the U.S. undergoing breast reconstruction annually, the demand for diverse solutions continues to grow.
This FDA approval marks a significant advancement in breast reconstruction options for women with larger cup sizes and a step toward equitable healthcare, ensuring that all women, regardless of body size or racial background, have access to high-quality reconstruction options. Minority women, particularly those with higher BMIs or larger body frames, face significant barriers to accessing appropriate breast reconstruction options, including the availability of larger implants. The lack of suitable implant options means many of these women either forego reconstruction or receive suboptimal results, leading to significant disparities in post-mastectomy care.
PSP: Could you elaborate on the insights gained from the ATHENA study and how they influenced the development and approval process for these implants?
Brzulja: The ATHENA study has been pivotal in shaping our understanding of patient outcomes in breast reconstruction. This prospective, multicenter, ongoing 10-year study has enrolled 400 women who underwent primary or revision reconstruction, providing us with invaluable data on safety, effectiveness, and patient satisfaction with these larger-volume implants. The FDA approval was supported by three-year data, which demonstrated that MemoryGel Enhance larger-volume silicone breast implants are safe, effective, and a viable option for patients with larger breasts who request postmastectomy, implant-based reconstruction.
Introducing MemoryGel Enhance to the market underscores the importance of incorporating feedback from patients and surgeons and leveraging real-world insights to deliver solutions that address their needs. By prioritizing inclusivity and meaningful innovation, we aim to support comprehensive care and ensure all breast reconstruction patients, regardless of race or body type, have access to the highest standard of care.
PSP: How does Mentor plan to address the concerns and considerations of patients and surgeons regarding the safety of larger implants?
Brzulja: Nothing is more important to us than the health and safety of the patients who choose our products. We adhere to the highest standards of safety. Every product we make undergoes rigorous testing, and the process never stops. MemoryGel™ Enhance Implants have been thoroughly tested and are backed by robust clinical data from the ATHENA study. For larger implants, we’ve incorporated advanced materials and engineering techniques to ensure structural integrity and durability while maintaining a natural feel.
Additionally, we prioritize education and transparency, providing surgeons with comprehensive resources and training to support informed decision-making. This ensures patient safety and well-being remain a top priority throughout the process. We’re proud of the long-standing safety of our implants and the respect we’ve earned from the breast aesthetics community worldwide for our high standards and leadership.
PSP: What steps is Mentor taking to ensure surgeons are equipped to use these new implants effectively, considering their unique size and features?
Brzulja: We understand how crucial it is for plastic surgeons to be fully equipped and familiar with our new implants, particularly given their unique sizes and features. To that end, we have implemented several robust initiatives to ensure surgeons are prepared to use our products safely and effectively:
- Required Device Training: Before placing an order for MemoryGel™ Enhance products, surgeons must complete comprehensive device training. This ensures they are knowledgeable about the specific features and functionalities of the implants.
- Peer-to-Peer Training from ATHENA Study Surgeons: We leverage the expertise of surgeons from the ATHENA study to provide valuable insights and guidance. These peer-to-peer training opportunities allow surgeons to learn from their colleagues’ experiences and techniques.
- HCP Surgical Pearls and Best Practices: We provide healthcare professionals with a collection of surgical pearls and best practices that highlight effective techniques and considerations specific to our implants.
- Surgical Videos and Commentary: To further support learning, we offer surgical videos showcasing real procedures with commentary from expert surgeons. These videos provide practical tips and insights to enhance surgical outcomes.
- Product Catalog with Dimensions: Our comprehensive product catalog includes detailed dimensions for each implant, serving as a resource for surgeons to make decisions that best suit their patients’ unique anatomies.
Through these professional education initiatives, we are committed to equipping surgeons with the knowledge and confidence to use MemoryGel Enhance Implants successfully. We believe continuous education and support are essential to achieving the highest standards of patient care and surgical excellence.
PSP: What are the anticipated challenges in launching these implants in the U.S. market in mid-2025, and how is Mentor preparing to address them?
Brzulja: Bringing innovative products like MemoryGel Enhance to market involves ensuring seamless manufacturing, distribution, and preparation to meet demand. Our manufacturing teams are ramping up production to ensure a reliable supply and timely delivery in mid-2025. Equally important is supporting surgeons through education and training to ensure they have the tools and knowledge to use our new MemoryGel™ Enhance Implants successfully.
PSP: How does this innovation fit into Mentor’s broader strategy for advancing breast aesthetics and reconstruction within Johnson & Johnson MedTech?
Brzulja: The launch of MemoryGel Enhance Breast Implants represents a pivotal step in our mission to shape the future of breast aesthetics and reconstruction, while exemplifying Johnson & Johnson MedTech’s purpose to transform medical intervention. Together, we are dedicated to driving breakthrough innovation that addresses unmet needs, reimagines health, and empowers everyone to live their best life. This innovation highlights our commitment to delivering smarter, more personalized solutions that improve patient outcomes, elevate surgical possibilities, and transform care for women worldwide with unique reconstruction needs.
