FDA-Cleared Single-Port Robotic Nipple-Sparing Mastectomy Performed at Community Hospital for the First Time

A patient at Sutter's Alta Bates Summit Medical Center (搜索)搜索该词条 in Oakland has become the first person in the United States to receive a single-port robotic nipple-sparing mastectomy at a community hospital outside a clinical trial, marking a milestone in the dissemination of a newly FDA-cleared surgical approach that may preserve more sensation than traditional mastectomy.

Vicky Pan, a 46-year-old pharmacist from Moraga, California, underwent the procedure in March 2025 after being diagnosed with triple-negative breast cancer (搜索)搜索该疾病 — an aggressive, fast-moving form of the disease — several months after a clear mammogram. The surgery was performed by Dr. Rita Kwan-Feinberg using the da Vinci single-port (SP) surgical system, which the Food and Drug Administration cleared for nipple-sparing mastectomies in December 2025.

"I'm still me," Pan said upon waking from the double mastectomy, reflecting on a procedure designed to minimize the physical losses she had feared during nine punishing months of chemotherapy that had taken her hair, eyebrows, and eyelashes.

FDA Clearance and Clinical Evidence

The FDA's clearance decision was informed by a randomized trial involving 53 patients that found no difference in short-term safety between the robotic and traditional procedures. Among the 26 patients who underwent robotic surgery, none required conversion to an open procedure, and surgeons achieved clear margins in every case. The FDA document did not draw conclusions about long-term cancer outcomes or preserved sensation.

The single-port approach means the entire operation is conducted through a single incision beneath the armpit. During Pan's operation, Kwan-Feinberg sat at a console and used hand and foot controls to guide the robot's small 3D camera and surgical instruments through an incision beneath each arm.

"Because there's a lot less tissue trauma, there is a lot less pain, there's faster healing and the cosmetic outcome is great," Kwan-Feinberg said. She noted that the camera provides a detailed view of blood vessels, nerves, and "that perfect plane between the breast tissue and the underside of the skin," potentially allowing greater precision in removing cancer and breast tissue.

Sensation Preservation Data

The potential for preserved sensation represents one of the most compelling aspects of the procedure. Dr. Deborah Farr, a University of Texas Southwestern surgeon who helped bring the robotic procedure to the United States, led a four-year study that began in 2020 and involved 20 women. The case series, published in JAMA Surgery in 2024, found that the single-port procedure was safe and feasible. Among patients tested for sensation, researchers reported that 95% of breast-skin sensation and 55% of nipple sensation were preserved after surgery.

"Even if the reconstructed breasts looked fantastic, patients would often feel as if their breasts were numb and detached, similar to how your legs feel after getting an epidural," Farr wrote in a 2025 article about the procedure.

Dr. Laura Dominici, a breast cancer surgeon at Boston's Dana-Farber Cancer Institute and associate professor at Harvard Medical School, noted that the procedure follows a broader trend toward less-invasive mastectomies. "I think probably the most compelling thing that people seem to be talking about is whether it may actually preserve more sensation for a patient, because usually after mastectomy, the skin and the nipples are pretty numb," she said. However, Dominici cautioned against calling the surgery "groundbreaking," citing limited data from "a small group of select patients with select surgeons."

Patient Eligibility and Limitations

Kwan-Feinberg emphasized that the procedure is not suitable for most women with breast cancer. Most patients undergo breast-conserving lumpectomies, while fewer than 30% undergo mastectomies. A still-smaller percentage qualify for nipple-sparing surgery, whether robotic or traditional. Eligibility depends on the size and shape of the natural breast, the location of the nipple-areola complex, and the cancer's proximity to the nipple.

Pan had no known elevated risk factors or family history of breast cancer — a scenario Kwan-Feinberg described as "the most common scenario." When doctors advised mastectomy, Pan chose to have both breasts removed to reduce the likelihood of facing breast cancer again.

Recovery and Outcomes

Pan spent just one night in the hospital, barely needed pain medication, and was left with two paper-clip-length incisions hidden on either side of her chest. Three weeks after surgery, she traveled with her husband and two sons to Monterey. "I hope more women have this option," she said.

Plastic surgeon Dr. David S. Chang placed temporary expanders immediately after Kwan-Feinberg completed the mastectomy. Pan's breast reconstruction is scheduled for December 2025. She is finishing several more rounds of immunotherapy and chemotherapy and hopes to return to work as a medical information pharmacist early next year.

"The sensation remaining in my chest makes a huge difference," Pan said. "I mean it's not 100%, but you know I can still feel my breasts. I can still feel when I have a shirt on."

Technology Adoption

Kwan-Feinberg followed Farr's work in Texas and sought to bring the surgery to Alta Bates Summit after the FDA clearance. Philanthropist Peter Read donated $2 million to purchase the robotic platform, which was named "Carol" in honor of his wife who died of breast cancer.

The da Vinci SP system represents an evolution in robotic-assisted surgery, which has gained widespread acceptance in the United States primarily through multi-port techniques using multiple robotic arms and incisions. The Cleveland Clinic first used the single-port platform in the U.S. in 2018 for urology surgery. Surgeons in Europe and South Korea pioneered its use in breast surgery before Farr and her colleagues began the U.S. clinical trial in 2020.

In the dozen surgeries performed at Alta Bates Summit to date, Chang said the smaller incisions have caused "less trauma overall," noting "there's less disruption of blood supply, and then, as well, less injury from having to retract on the skin."

Pan remains realistic about the possibility that her triple-negative cancer could return and will be closely monitored for the next five years, when recurrence is most likely according to the National Breast Cancer Foundation. "If I have five years left, how do I want to spend my time? Every day is precious," she said.