New Breast Implant Closes the Reconstruction Gap for 1 in 7 Women After Breast Cancer Surgery

Irvine, Calif. – May 13, 2025 – Johnson & Johnson MedTech, a global leader in breast aesthetics and reconstruction¹, today announced the U.S. launch of MENTOR™ MemoryGel™ Enhance Breast Implants, filling a critical gap in comprehensive breast cancer care for women who have undergone a mastectomy.

Designed for primary or revision reconstruction following a mastectomy, the FDA-approved MENTOR™ MemoryGel™ Enhance Breast Implants are the first and only implant line developed specifically for women with larger breasts, offering sizes from 930 cc to 1445 cc and giving surgeons the ability to deliver more personalized outcomes without compromising aesthetic results. The implants address the needs of approximately 15% of post-mastectomy patients who previously lacked access to appropriately sized implants for reconstruction.²

“Johnson & Johnson MedTech is delivering on our promise to make breast reconstruction more inclusive, supportive, and empowering for every woman,” said Alenka Brzulja, Worldwide President, Aesthetics & Reconstruction, Johnson & Johnson MedTech. “Too many women have been left without options that helped them achieve their desired outcomes. The availability of MemoryGel™ Enhance Implants brings us closer to addressing this gap – because every woman deserves access to reconstruction options that reflect her body and her goals.”

Offering choice for patients post-mastectomy
With breast cancer rates continuing to rise across the U.S., more than 246,000 women undergo a mastectomy each year as part of breast cancer treatment or prevention³. Breast reconstruction offers these women the option to rebuild their breasts after surgery using implants, restoring both form and volume. Without a size-appropriate implant, patients may face symmetry issues, suboptimal aesthetic outcomes, or the need for additional surgeries to achieve their desired results.⁴ Until now, the largest implant available was 800 cc, making it difficult for patients with larger body frames or extensive tissue removal to achieve proportional results and leading to lower reconstruction rates.⁴

MemoryGel™ Enhance Implants offer the same trusted proprietary gel formulation, softness, and shape retention* as the existing MENTOR™ portfolio and are now available in larger sizes with an expanded range of base widths, projections, and volumes to better meet the reconstruction needs of more patients. The MENTOR™ Enhance Product Family includes MemoryGel™ Enhance Implants, CPX™4 Plus Enhance Breast Tissue Expanders and MemoryGel™ Enhance Breast Implant Sizers, designed to work together to support a complete reconstruction experience.

“Despite being a standard part of post-mastectomy care, reconstruction options have not kept pace with the diverse needs of today’s patient population,” said Mark Migliori, M.D., FACS*, board-certified plastic surgeon in Edina, Minnesota, who performed the first procedure with the new implant. “For patients who require a larger-volume implant than what was previously available, they now have an option that helps them to become whole again.”

MENTOR™ MemoryGel™ Enhance Breast Implants were approved by the U.S. FDA for primary and revision reconstruction in November 2024. Three-year data from the Athena Study – the largest multicenter, prospective 10-year clinical trial of breast implants for reconstruction – demonstrated the safety and efficacy of larger implants, including 96% overall patient satisfaction, low complication rates, and significant improvements in physical, psychosocial, and sexual well-being.⁵

* Dr. Migliori is a consultant for Mentor Worldwide LLC but was not compensated for this procedure or his opinions in this press release

WARNING:

• Breast implants are not considered lifetime devices. The longer people have them, the greater the chances are that they will develop complications, some of which will require more surgery.
• Breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphona (BIA-ALCL). This cancer occurs more commonly in patients with textured breast implants than smooth implants, although rates are not well defined. Some patients have died from BIA-ALCL.
• Patients receiving breast implants have reported a variety of systemic symptoms such as joint pain, muscle aches, confusion, chronic fatigue, autoimmune diseases and others. Individual patient risk for developing these symptoms has not been well established. Some patients report complete resolution of symptoms when the implants are removed without replacement.

Caution: US law restricts this device to sale by or on the order of a physician.

The sale and distribution of Mentor Breast Implant Devices are restricted to users and/or user facilities that provide information to patients about the risks and benefits of the device prior to its use in the form and manner specified in approved labeling to be provided by Mentor Worldwide LLC.

Important Safety Information:

The MENTOR™ MemoryGel™ Enhance Breast Implants are indicated for breast reconstruction. Breast implant surgery should not be performed in women:
• With active infection anywhere in their body
• With existing cancer or pre-cancer of their breasts who have not received adequate treatment for those conditions
• Who are currently pregnant or nursing
Safety and effectiveness have not been established in patients with autoimmune diseases (for example lupus and scleroderma), a weakened immune system, conditions that interfere with wound healing and blood clotting, or reduced blood supply to breast tissue. Patients with a diagnosis of depression, or other mental health disorders, should wait until resolution or stabilization of these conditions prior to undergoing breast implantation surgery.

Breast implants are not lifetime devices and breast implantation may not be a one-time surgery. There are risks associated with breast implant surgery. The chance of developing complications increases over time. You may need additional unplanned surgeries on your breasts because of complications or unacceptable cosmetic outcomes. Many of the changes to your breast following implantation are irreversible (cannot be undone) and breast implants may affect your ability to breastfeed, either by reducing or eliminating milk production.

The most common complications for breast reconstruction with MENTOR™ MemoryGel™ Enhance Breast Implants include any reoperation, implant removal with or without replacement, and capsular contracture. A lower risk of complication is rupture. The health consequences of a ruptured silicone gel breast implant have not been fully established. MRI screenings are recommended three years after initial implant surgery and then every two years after to detect silent rupture. Breast implants are also associated with the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), an uncommon type of lymphoma. An individual’s risk of developing BIA-ALCL with MENTOR™ MemoryGel™ Enhance Breast Implants is low based on the incidence of worldwide cases.

Detailed information regarding the risks and benefits associated with MENTOR™ MemoryGel™ Enhance Breast Implants is provided in MemoryGel™ Enhance Breast Implants: Important Information for Reconstruction Patients about MENTOR™ MemoryGel™ Enhance Breast Implants. These brochures are available from your surgeon or visit www.mentorwwllc.com. It is important that you read and understand these brochures when considering MENTOR™ MemoryGel™ Enhance Breast Implants.

CPX4™ Enhance Breast Tissue Expanders are used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision, and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months. CPX4™ Enhance Breast Tissue Expanders contain a magnet within the internal injection domes and are NOT MRI compatible. The device could be moved by the MRI causing pain or displacement, potentially resulting in a revision surgery. DO NOT use the CPX4™ Enhance Breast Tissue Expander in patients that have a previously implanted device such as pacemakers, drug infusion devices, artificial sensing devices, etc. that could be affected by a magnetic field. Mentor has not tested the effects of radiation therapy with CPX4™ Enhance Breast Tissue Expanders devices. The incidence of extrusion of the expander has been shown to increase when the expander has been placed in injured areas: scarred, heavily irradiated or burned tissue, crushed bone areas, where severe surgical reduction of the area has previously been performed; and where steroids are used in the surgical pocket. Detailed information about indications, contraindications, warnings, and precautions associated with the use of CPX4™ Enhance Breast Tissue Expanders is provided in the Instructions for Use (IFU) available online at www.mentorwwllc.com.

About Aesthetics & Reconstruction
At Johnson & Johnson MedTech, we are redefining possibilities in breast aesthetics by delivering a comprehensive portfolio of science-based, evidence-backed solutions designed to help women enhance and restore their confidence and quality of life. As the #1 global brand, we take pride in being a trusted partner in breast augmentation and reconstruction for both consumers and healthcare professionals. In everything we do, we use a patient-first approach that encourages choice and personal empowerment. For more than 40 years, MENTOR™ products have been developed with this very goal in mind. Available in 118 countries, MENTOR™ Breast Implants have been chosen by over 9 million women worldwide.

About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more about our MedTech sector’s global scale and deep expertise in cardiovascular, orthopaedics, surgery and vision solutions at https://thenext.jnjmedtech.com. Follow us at @JNJMedTech and on LinkedIn. Mentor Worldwide LLC is part of Johnson & Johnson MedTech.

Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding MENTOR™ MemoryGel™ Enhance Breast Implants. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Mentor Worldwide LLC, Medical Device Business Services, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Mentor Worldwide LLC, Medical Device Business Services, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

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© Johnson & Johnson and its affiliates. 2025. All rights reserved.

Footnotes
*Based on benchtop testing comparing the MENTOR™ MemoryGel™ Portfolio of Round Breast Implants to the available Allergan® & Sientra® Portfolio of Round Gel Breast Implants for NATRELLE®, SoftTouch & Cohesive and Sientra®, HSC and HSC+.

¹ Mentor Worldwide LLC. GBI Data through Q1 2020 for Implants, Expanders and Sizers.

² Howarth, Ashley & Rodriguez, Abigail & Gargya, Vipul & Lucas, Heather & Mahabir, Raman. (2017). Larger breast implants warranted for post-mastectomy reconstruction. Plastic and Aesthetic Research. 4. 215. 10.20517/2347-9264.2017.80.

³ Breast Implants and Reconstructive Devices | Market Insights | US | 2023

⁴ Barnow A, Canfield T, Liao R, et al. Breast Reconstruction Among Commercially Insured Women With Breast Cancer in the United States. Ann Plast Surg. 2018;81(2):220-227.

⁵ Mentor Worldwide LLC. Three-Year Interim Clinical Study Report. April 2023.