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Statement on MarginProbe to the FDA General and Plastic Surgery Devices Panel Advisory Committee

June 21, 2012
Washington, DC

My name is Wayne Shields, and I am president and CEO of the Association of Reproductive Health Professionals. I’m pleased to provide comments today on behalf of ARHP’s board, staff, and 12,000 health professional members.

Background

ARHP is a non-profit medical professional association representing the entire reproductive and sexual health care team, including Obstetrician/Gynecologists and other physicians, advanced practice clinicians, researchers, students, educators, pharmacists, and other professionals in reproductive health.

Our mission is education and we do this by translating evidence-based research and guidelines into practice for frontline clinicians to improve patient care. For nearly fifty years, ARHP has served as the leading source for trusted medical education and information on reproductive and sexual health. ARHP supports the availability of a wide range of safe, effective technologies that can help improve patient care and quality of life. We are also concerned about the high cost of health care and support technologies that are shown to be cost-effective.

ARHP and I have not received any financial support from Dune Medical Devices, the sponsor of the MarginProbe application. 

Statement of Support

ARHP’s leadership recognizes the critically important role that screening and treatment play in the fight against breast cancer. In 2012, almost 227,000 women will be diagnosed with breast cancer, and nearly 40,000 women will die from the disease. ARHP supports the availability of all safe and effective breast cancer treatment options to help reduce the personal and societal toll of breast cancer. This is the reason that I am honored to appear before the Panel today to speak in support of the MarginProbe PMA. 

By improving surgeons’ ability to detect cancerous margins in the first place, we believe that MarginProbe will help to address the variability in reexcision rates and improve the quality of breast conserving surgery. As the clinical trials show, the utilization of MarginProbe helps surgeons to identify more positive margins at the time of surgery, remove additional tissue, and reduce the reoperation rate by half. This real-time detection and removal of cancer in the operating room will save thousands of women from having to endure another lumpectomy procedure.

In addition to MarginProbe’s impressive clinical data which has already been featured today, ARHP’ clinical leadership has reviewed a cost-effectiveness analysis presented at the 2012 European Breast Cancer Conference by professors from the University of California at San Francisco. The UCSF analysis found that intraoperative lumpectomy margin assessment techniques such as MarginProbe are more cost-effective than standard of care post-surgical pathology. The authors conclude that since MarginProbe reduces the reoperation rate, it saves the healthcare system money and improves patients’ quality of life.

ARHP commends this Panel for its work in considering the MarginProbe application, and urges you to recommend approval of this device. Improving breast conserving surgery will be of immense benefit to women, medical professionals, and society at large.

Thank you for the opportunity to present ARHP’s views to you. We look forward to the results of the Panel’s deliberations.

Respectfully submitted,


Wayne C. Shields
ARHP President and CEO