A look at the clinical need behind the MemoryGel Enhance launch—and how it’s expanding reconstructive options for patients with larger volume requirements.
For years, women undergoing breast reconstruction after mastectomy have faced a significant limitation: the lack of implant options for those with larger frames or more extensive tissue loss. With implant sizes previously capped at 800 cc, many patients were forced to compromise on aesthetic outcomes or forgo reconstruction altogether. Addressing this critical gap in care, Johnson & Johnson MedTech has launched the MENTOR MemoryGel Enhance Breast Implants, FDA-approved for primary or revision reconstruction and available in sizes ranging from 930 cc to 1445 cc. The new implants aim to provide more personalized and inclusive options for post-mastectomy patients, supporting improved symmetry, satisfaction, and surgical outcomes.
Plastic Surgery Practice spoke to Mark Migliori, MD, FACS, a board-certified plastic surgeon and ATHENA Study investigator who performed the first case using MemoryGel Enhance. Here, he shares his clinical insights and experience with this new implant. With nearly 30 years in aesthetic and reconstructive breast surgery, Migliori discusses how these implants are expanding reconstructive possibilities for patients who were previously underserved.
Plastic Surgery Practice: You performed the first MemoryGel Enhance Breast Implant case—can you walk us through the key clinical considerations that went into patient selection and surgical planning for that procedure?
Mark Migliori, MD, FACS: Interestingly, the first patient enrolled in the study had her mastectomy before The Athena Study of the MemoryGel Enhance implant had been proposed. The patient had a 1300-1400 gram breast and wanted to keep a full size but was willing to be smaller than her preoperative size. She had a bilateral mastectomy with immediate tissue expander reconstruction in a full muscular pocket without ADM. This was a textured 550 cc CPX expander.
We had set the expectation based on the limitations of then-available implant sizes. She expanded initially up to 750 cc and I informed her that I did not have implants available with volumes greater than 800 cc. She felt under-sized but was considering second stage reconstruction with a compromise of size. This was approximately a year prior to the start of the study.
I had received word that J&J MedTech was considering initiating a study of larger sized implants. I presented this to the patient and she was willing to wait for her second stage reconstruction so she could participate in the study. She felt it was important to be able to have the larger size implant. We knowingly used her expander in an off-label way and expanded her up to 1000 cc. She waited 9 months to enroll in the study. In May 2016, a second stage reconstruction was performed with 930 cc implants. She has been followed for 9 years through the study and has maintained her result with high satisfaction and no evidence of rupture or adverse event.
This case highlights several points. I almost always recommend a staged expander reconstruction because it gives the patient the opportunity to experiment with size interactively and incrementally. This patient was able to determine that the size limitation of the standard 800 cc implant was not satisfactory for her reconstruction. Previously, she would have had to compromise due to limited implant options.
It also illustrates the motivation of a patient to reach her goals with her willingness to wait many months to be enrolled in the study. Finally, the off-label use of the expander illustrated the important concept of controlling the pocket to achieve a durable result. I had chosen a 550 cc expander for this patient because the base width of her breast was best matched to this device. Although expanding to a larger volume allowed for more projection, I did not want to have excessive lateral expansion. That proved to be important in allowing the implant to remain in good position without inferior or lateral slippage throughout 9 years of follow up.
When I now evaluate a patient at the initial consultation, I have confidence that I can achieve larger sizes. I still use the base width of the breast as the primary determinant of the expander choice, and I do not hesitate to overexpand past the nominal fill volumes. It was several years into the study before a CPX expander designed to reach the sizes of the MemoryGel Enhance implants became available. Many of the early patients had expanders with nominal volumes significantly lower than their final expansions. Larger expanders are now available, and we can better predict those patients for whom this size implant may be necessary. As in this case, however, I will continue to expand to these volumes even with a smaller expander if the soft tissue durability allows for successful expansion.
PSP: How do these larger implants address the unmet needs you’ve seen in your own reconstruction patient population?
Migliori: The patients with larger frames or larger breasts have been underserved until now. The prior limitations were such that plastic surgeons had to inform patients that it was technically impossible to create breast sizes greater than 800 cc and patients had to compromise their expectations. While it is still paramount to educate patients about realistic expectations regarding breast reconstruction, we have now functionally extended our ability to adequately reconstruct mastectomy patients desiring a larger breast.
PSP: What should your colleagues know about incorporating these implants into their reconstruction offering—both from a surgical technique and practice workflow perspective?
Migliori: Effective implant base reconstruction requires meticulous planning and execution to achieve satisfactory and predictable results. This is true for all sizes of breasts and implants. The use of Memory Gel Enhance implants requires the same precision. Pocket control is paramount. In most instances, a staged expander approach in the immediate setting allows for more accurate control of the pocket positioning. In a revision reconstruction, I have a low threshold to go back to an expander to regain that control in a patient with an inadequate result.
The weight of these larger implants is such that it will amplify any problems with pocket placement, particularly along the inframammary fold and lateral margin. Although smaller sized implant reconstructions have these same considerations, the larger implant demands even more meticulous execution.
PSP: Can you discuss how the implant’s expanded size range impacts your ability to achieve symmetry and proportion in patients with larger body frames or significant tissue loss?
Migliori: Having the experience and knowledge of the MemoryGel Enhance devices, I feel much more confident in the initial consultation providing a realistic expectation of the results that can now be attained for patients desiring larger breasts.
PSP: How does the gel consistency and handling of the MemoryGel Enhance compare to the existing MemoryGel portfolio in the OR?
Migliori: Memory Gel Enhance implants are the extension of the Ultra High profile MemoryGel line. They have the same cohesiveness and textural qualities, and are designed to control base diameter and maximize projection. Insertion requires a proportionately larger incision; the average incision size is between 9 cm and 10 cm. The weight of the implant requires firm handling. Moreover, the same care during insertion and closure is necessary as with all implants.
PSP: What clinical benefits have you observed or expect to see in terms of patient outcomes and satisfaction with these larger volume implants?
Migliori: Patient satisfaction is high in the Athena study. This is a population that often has had to accept compromise in many aspects of their health care. The ability to provide an effective and durable reconstruction in this population has expanded our ability to provide an important quality of life procedure to this patient population undergoing mastectomy. The Ultra High Profile allows for optimal projection and definition while minimizing lateral spread.
PSP: Are there specific challenges or limitations surgeons should be aware of when using these larger implants in primary or revision reconstruction?
Migliori: Co-morbidities are common in this population of patients. Patient safety is the primary concern. The technical aspects of the mastectomy can be challenging in these patients. If there is concern for soft tissue quality following mastectomy or if there are concerns for operative complications at the time of mastectomy, it is wise to consider delayed reconstruction to allow for improved control of soft tissue durability.
If pocket control has not been achieved in a previous reconstruction, a revision may require return to an expander to regain that control. Meticulous attention to detail at the expander phase ensures a more predictable result at the second stage. The availability of single use sizers at the time of second stage is also an important technical advance that allows intraoperative assessment of pocket characteristics and final result. Having multiple sizes at the time of implant placement provides flexibility when faced with unexpected intraoperative assessments.
I believe the most predictable results are obtained with a partial subpectoral expander/implant placement using an ADM sling. This has allowed for accurate positioning of the inframammary fold and lateral fold. It also prevents symmastia and reduces the late soft tissue ptosis of a prepectoral placement. The larger implant weight will exert significant forces on the skin envelope with a prepectoral placement. If there is any concern for the thickness of the mastectomy flaps, prepectoral placement should be reconsidered.
PSP: Based on your participation in the ATHENA study, how do the clinical outcomes—including complication rates and patient satisfaction—compare to smaller volume implants or other reconstructive options?
Migliori: Clinical outcomes, complications, rates of reoperation, and patient satisfaction mirror the results of published data for smaller implant-based reconstructions. Over 95% of patients indicated that they would have this surgery again and surgeons indicated 98% satisfaction with the results in primary reconstruction and 96% in revision reconstruction. The prospective Athena Study of the MemoryGel Enhance implant line has shown these devices to be safe and effective in reconstruction of the larger breast.
To understand the broader impact of this launch and how it reflects Johnson & Johnson MedTech’s long-term strategy to improve access and inclusivity in breast reconstruction, Plastic Surgery Practice spoke with Alenka Brzulja, worldwide president of aesthetics & reconstruction at J&J MedTech. Brzulja offers insights into the development process behind the MemoryGel Enhance Breast Implants, the findings of the ATHENA Study, and the company’s initiatives to support plastic surgeons in integrating this innovation into clinical practice.
PSP: What drove J&J MedTech to develop the MemoryGel Enhance Implants, and how did patient and surgeon feedback shape this product?
Alenka Brzulja: With over 246,000 women undergoing mastectomies each year in the United States, J&J MedTech identified a critical gap in reconstruction options—especially for the 15% of patients who lacked access to appropriately sized implants. The previous size limit of 800 cc made it difficult for many women to achieve the outcomes they deserved from breast reconstruction post-mastectomy. Feedback from both patients and surgeons highlighted the need for larger, more inclusive implant options. In response, J&J MedTech developed MENTOR MemoryGel Enhance Breast Implants, supported by findings from the ATHENA Study, which demonstrated the safety, effectiveness, and high satisfaction rates of larger implants, along with meaningful improvements in patient well-being.
PSP: How does this launch align with J&J MedTech’s broader mission to improve access and inclusivity in breast reconstruction?
Brzulja: The launch of the MENTOR MemoryGel Enhance Breast Implants reflects J&J MedTech’s commitment to improving access and inclusivity in breast reconstruction by expanding its comprehensive and diverse product portfolio. This innovation enables surgeons to offer more personalized options tailored to individual patient needs and underscores the company’s dedication to standing behind all women. By putting patient needs at the center of product development, we continue to deliver meaningful innovation and broaden access to breast reconstruction solutions for every woman.
PSP: What are the key findings from the ATHENA study that surgeons should be aware of when considering these implants for their practice?
Brzulja: The ATHENA Study—the largest multicenter, prospective 10-year trial of breast implants in women with larger breasts—demonstrated that MENTOR MemoryGel Enhance Breast Implants are safe, effective, and well-suited for postmastectomy reconstruction. Key findings from the three-year results were:
- 96% overall patient satisfaction (95% for primary reconstruction, 97% for revision).
- Significant improvements in Breast-Q scores across all domains: satisfaction with breasts, psychosocial, physical, and sexual well-being.
- Acceptable complication rates, comparable to those of regular-sized implants, even in patients with larger breasts and higher BMI.
- For unilateral reconstructions, larger implants helped achieve better symmetry with the unaffected breast
PSP: How is J&J MedTech supporting plastic surgeons in integrating this solution—through training, resources, or patient education tools?
Brzulja: To support surgeons in successfully using MENTOR MemoryGel Enhance Breast Implants, we’ve developed a robust suite of educational resources. This includes our OnPoint seminar series—featuring interactive learning sessions, live Q&As, and peer-to-peer training led by expert faculty and ATHENA Study investigators. Surgeons also benefit from required device training, surgical videos with expert commentary, surgical pearls and best practices, and a detailed product catalog with implant dimensions. Additionally, our extensively trained representatives provide hands-on support in the field. Our goal is to equip surgeons with the knowledge, confidence, and ongoing support needed to make informed decisions and deliver the best outcomes for their patients.
PSP: Looking ahead, how do you see this product changing the landscape of post-mastectomy care and influencing reconstruction rates among underserved patient populations?
Brzulja: The launch of MENTOR MemoryGel Enhance Breast Implants has the potential to significantly improve post-mastectomy care by addressing a long-standing gap in reconstruction options for women with larger breast sizes or extensive tissue removal. As the first and only implants designed specifically for these patients, they provide access to proportionately sized options that were previously unavailable, helping reduce aesthetic compromises and the need for additional surgeries. By expanding the range of sizes, base widths, and volumes—while maintaining the trusted quality of the existing J&J MedTech product portfolio—this innovation supports more inclusive, personalized care. Ultimately, it may help increase reconstruction rates among underserved populations who have historically lacked access to appropriate implant solutions. PSP
Photo: Johnson & Johnson MedTech
