Robotic-Assisted Mastectomy Has Potential, but Is a Cautionary Tale

“The main point of using these port management systems is to move the robotic arms as far away from the patient’s chest as possible to allow for more working space of the robotic arms,” said Ko Un “Clara” Park, MD, FACS.

The use of a robot to assist during a mastectomy can lead to less invasive or less destructive surgeries, such as nipple-sparring mastectomy, but its not without caution. The presentations of various techniques, as well as current updates and future directions, were presented by Ko Un “Clara” Park, MD, FACS, during the 41st Annual Miami Breast Cancer Conference® hosted by Physician’s Education Resource^® (PER).

However, Park, an associate surgeon in the Division of Breast Surgery and director of research of the Breast Surgery Network Sites at Brigham and Women’s Hospital noted that nipple-sparring surgery may cause various challenges for surgeons, and she highlighted FDA warnings regarding using robot-assisted surgery for nipple-sparring mastectomy.

Nipple-sparing Mastectomy

During nipple-sparing mastectomy, the nipple and areola are preserved with a hidden scar and a more natural appearance of the breast.^1,2 Additionally, this can benefit the patient psychologically and emotionally, as well as show improved satisfaction.

However, while this procedure can be effective for the patient, there are many technical challenges that the surgeon must overcome. Park noted that a mastectomy is essentially a “dark tunnel” in which the skin flap is dissected. Because of the high muscle activity of the anterior deltoid, patients may experience pain after surgery.

Additionally, there are ergonomic challenges for the surgeons associated with conducting this surgery. She cited a study by Bartnicka et al, where a surgeon is found to be standing at a 90-degree angle trying to complete the procedure.³ Coupled with multiple surgeries like this per day, clinicians can face an impact on their quality of life.

The use of a robot would allow for a surgeon to sit comfortably, and use the robotic arms to reduce tremors, which in turn allows for better ergonomics.⁴ The robot also boasts a 3D camera that can allow for magnification, light, and increased range of motion on the instrument tip.

There have been a few different groups in Europe that have looked at the use of nipple-sparing surgery and compared it with robotic-assisted use. These studies began in 2013, and Park noted there is nearly a 10-year difference since this approach began to be studied. Currently, it’s not widely being used because of device safety and the regulation from the FDA.

FDA Recommendation on Robotic-Assisted Surgery

In February 2019, the FDA released guidance for robotic-assisted surgeries in the women’s health space, specifically that of mastectomies.⁵ At the time of the release, the FDA had not granted marketing authorization for the use of robotic-assisted surgery for patients with mastectomy. It cited multiple clinical trials that had reported poor outcomes for patients who underwent this procedure. It is recommended that patients and providers discuss the benefits, risks, and any alternative procedures involved with this surgery before deciding.

“In order to answer the question on oncologic safety of robotic nipple-sparing mastectomy, we used residual breast tissue after the operation,” Park said regarding a study she led looking at residual breast tissue after nipple-sparing surgery.⁶

Park and her colleagues completed 5 cadaveric robot-assisted nipple-sparing mastectomies. Of the 70 biopsies that occurred, residual breast tissue was observed in 11 biopsies, with the most common site of residual breast tissue being the nipple-areolar complex. The study found that robotic-assisted nipple-sparing mastectomy can be effective and leave behind minimal residual breast tissue.

She also cited a recent study by Park et al, regarding the surgical safety of robotic and conventional nipple-sparing mastectomy followed by immediate breast reconstruction vs conventional nipple-sparing mastectomy.⁷ Most important was the nipple necrosis rate of 2.2% for those who underwent the robotic surgery compared with 7.8% for those who underwent conventional measures (P = .002).

Transitioning to discussing port management systems that are commercially available, Park mentioned the use of a single port system, which utilized a single incision for a patient with ductal carcinoma in situ.⁸ The patient did not experience any major complications aside from skin burns on the right breast.

“The main point of using these port management systems is to move the robotic arms as far away from the patient’s chest as possible to allow for more working space of the robotic arms,” said Park.

Future Directions of Robot-Assisted Surgery

There are many ongoing trials testing the safety of robotic-assisted nipple-sparing surgery. Hewitt et al gave practical guidelines for implementing a robotic breast program in various institutions.⁹ Highlights from this include applying for investigator device exemption approval from the FDA, developing technical expertise, establishing a team, communicating with oversight, and publishing the findings. For example, the Robot-assisted vs. Open Nipple-sparing Mastectomy With Immediate Breast Reconstruction (ROM) trial (NCT05490433) is randomizing 790 patients with stage 0 to IIIA breast cancer to each approach with hopes to determine the clinical importance of successive breast reconstruction.¹⁰ The primary end point is 5-year disease-free survival rate; secondary outcome measures are 5-year rates of overall survival , breast cancer–specific survival, distant recurrence-free survival, locoregional recurrence-ree survival, and nipple recurrence, among others.

To bring this closer to regular practice, Park noted that the first step is to obtain the FDA 510(k) premarket notification, and then continue to the investigational device exemption which allows clinical trials to be conducted. If the indication or use is significantly changed, the FDA requires a new 510(k) approval.

“We have to think of the regulatory requirement of robotics in the United States,” said Park.

References

1. Galimberti V, Morigi C, Bagnardi V, et al. Oncological outcomes of nipple-sparing mastectomy: a single-center experience of 1989 patients. Ann Surg Oncol. 2018;25(13):3849-3857. doi:10.1245/s10434-018-6759-0
2. Smith BL, Tang R, Rai U, et al. Oncologic safety of nipple-sparing mastectomy in women with breast cancer. J Am Coll Surg. 2017;225(3):361-365. doi:10.1016/j.jamcollsurg.2017.06.013
3. Bartnicka J, Piedrabuena A, Portilla R, et al. Ergonomics education in orthopedic surgery. LIFE: International Journal of Health and Life-Sciences. 2017;3(2):194-215. doi:10.20319/lijhls.2017.32.194215
4. Park KU, Lee S, Sarna A, et al. Prospective pilot study protocol evaluating the safety and feasibility of robot-assisted nipple-sparing mastectomy (RNSM). BMJ Open. 2021;11(11):e050173. Published 2021 Nov 15. doi:10.1136/bmjopen-2021-050173
5. FDA In Brief: FDA cautions patients, providers about using robotically-assisted surgical devices for mastectomy and other cancer-related surgeries. News release. FDA. February 28, 2019. Accessed March 11, 2024. https://shorturl.at/guyS9
6. Park KU, Tozbikian GH, Ferry D, et al. Residual breast tissue after robot-assisted nipple sparing mastectomy. Breast. 2021;55:25-29. doi:10.1016/j.breast.2020.11.022
7. Park HS, Lee J, Lai HW, et al. Surgical and oncologic outcomes of robotic and conventional nipple-sparing mastectomy with immediate reconstruction: international multicenter pooled data analysis. Ann Surg Oncol. 2022;29(11):6646-6657. doi:10.1245/s10434-022-11865-x
8. Park HS, Lee J, Lee H, Lee K, Song SY, Toesca A. Development of robotic mastectomy using a single-port surgical robot system. J Breast Cancer. 2020;23(1):107-112. doi:10.4048/jbc.2020.23.e3
9. Hewitt DB, Park KU. Safe technical innovation: development and implementation of a robotic breast operation program. Ann Surg Open. 2022;3(3):e178. doi:10.1097/AS9.0000000000000178
10. Robot-assisted vs. Open Nipple-sparing Mastectomy With Immediate Breast Reconstruction (ROM). ClinicalTrials.gov. Last Updated November 28, 2023. Accessed March 11, 2024. https://classic.clinicaltrials.gov/ct2/show/NCT05490433