Use of Tamoxifen to Reduce Breast Implant Capsule Formation and Capsular Contracture

A major complication associated with breast implant prostheses is the occurrence of capsular contracture, occurring in 20%-25% of patients. Severe forms of capsular contracture constitute failure of the reconstruction with significant implications for increased cost owing to an increased need for recurrent medical interventions, as well diminished quality of life for patients. Capsular contracture occurs as the result of the patient’s immunologic ‘foreign body’ response to the implant material. The inventors’ vision is to develop a technology whereby the active metabolites of Tamoxifen (endoxifen) are conjugated to implant biomaterial in a manner allowing for localized delivery of endoxifen. They anticipate that local delivery of endoxifen will successfully reduce capsule formation around implant material by reducing the immunologic foreign body response. This is a technology that could be licensed to implant manufacturers (breast, implantable cardiac devices, etc.)

Technology Overview:

Breast augmentation and reconstruction is a common practice, especially in those afflicted by breast cancer. One of the most common issues that comes with this process is the formation of capsular contracture. This is a direct result of the patient’s immunologic ‘foreign body’ response to the implant material, which can impact the need for significant medical interventions and diminished quality of life. The current pharmacologic treatment for breast cancer is the chemical compound known as Tamoxifen, which acts as a chemo-preventative medication for hormone sensitive breast cancers. A team of researchers at Nationwide Children’s Hospital and Ohio State University aims to localize the delivery of tamoxifen to significantly reduce the immunologic foreign body response around implant material for use in both cancer-based breast reconstruction and cosmetic procedures

Benefits:

No pharmacotherapeutics currently exist to address capsular contracture and no biomaterial advances have been made to specifically reduce the foreign body response to breast implants

Stage of Development:

Mouse studies are currently underway using systemic delivery of Tamoxifen for treatment of capsular contracture in breast implants. A manuscript is in preparation.

Future mouse studies will focus on local delivery of endoxifen for treatment of capsular contracture in breast implants; then look at other implant types and different coating types.

Potential Applications / Markets:

According to the report published by Allied Market Research, the medical implant industry estimated $85.38 billion in 2019, and is estimated to generate $147.46 billion by 2027, manifesting a CAGR of 7.2% from 2020 to 2027. According to a report published by Fortune Business Insights, the breast implant market was worth $2.76 billion in 2019 and is projected to reach $3.05 billion by the end of 2027, exhibiting a CAGR of 7.2% during the forecast period, 2020-2027.

Opportunity / Seeking:

-Licensing

IP Status:
Patent application submitted

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