Robotic Mastectomy in US: Starts, Draws Fire, Stops

Potential 'Disaster' or Evolutionary 'Next Step'?

Nick Mulcahy

February 07, 2019

Robotic mastectomy for invasive breast cancer was performed for the first time in the United States last year, but the move toward this surgical approach ground to a halt soon afterward.

The first such operation was performed in September 2018 by Stephen Chagares, MD, at the Monmouth County Medical Center in Long Branch, New Jersey.

Chagares "docked" the robot well off to the side of the breast. The resulting incision left a scar hidden under the armpit. The robotic nipple-sparing mastectomy involved total removal of breast tissue, followed immediately by implant placement.

The patient, Yvonne Zucco, was very satisfied, according to an article published in October in the Asbury Park Press.

"I don't even look like I had anything done," said Zucco, aged 56.

"To be able to wake from surgery, look down, not see any visible scars and have my nipples and areolas intact with implants in is amazing," she said in a press release about the surgery.

"Robotic mastectomy, with immediate reconstruction, opens the door to a new era of mastectomy and a new outlook for patients who are candidates," commented Chagares.

However, robotic mastectomy was soon stopped by the community-based center, which "decided to suspend the procedure until further review."

Months later, there has been no change in policy at Monmouth Medical Center since it issued its brief original statement, a spokesperson told Medscape Medical News this week.

What happened?

The answer appears to be that Hooman Noorchashm, MD, PhD, a Philadelphia-based surgeon turned patient advocate, became involved and raised questions about the safety and appropriateness of using the da Vinci robot (Intuitive Surgical Inc), which is not approved for mastectomy.

"Certainly, [robotic mastectomy] is not ready for prime time or widespread application in community hospital settings in the United States," Noorchashm commented in an email to journalists about the procedure and the case at Monmouth Medical Center.

However, this past week, Noorchashm upped his rhetoric, telling Medscape Medical News that the robotic mastectomy scenario in North Jersey — and events unfolding elsewhere — have the potential makings of the beginning of a public health "disaster."

The former cardiothoracic surgeon at Brigham and Women's Hospital in Boston believes he has a feel for such disasters, after his wife, Amy Reed, MD, died of uterine cancer in 2017 following a laparoscopic hysterectomy performed with a power morcellator that resulted in the upstaging of an undetected gynecologic cancer. The tool, which is regulated as a 510K device, was used for 20 years, during which time no randomized controlled trial was ever conducted that compared the safety and efficacy of the device with that of the standard of care, traditional hysterectomy. However, thanks to efforts by the couple, these devices now carry a warning label stating that they should not be used for most women who undergo hysterectomy or myomectomy for uterine fibroids.

"The reason why I am focused on robotic mastectomy is because I think there is a parallel [with hysterectomy via power morcellator] of selling cosmesis and convenience to women for a surgical operation," he said during an interview.

The US Food and Drug Administration (FDA) has a history of being lax in its oversight of 510K devices, which include the power morcellator and the da Vinci robot, he said. These devices can replace established standards of care without "proper evidence," he added.

It all comes down to trying to get a large specimen out of a small incision. Dr Hooman Noorchashm

Moreover, minimally invasive cancer surgery is not necessarily superior, he said, pointing to recent results showing that the treatment of cervical cancer with laparoscopic hysterectomy, which has long been touted as involving less morbididity than traditional hysterectomy, resulted in lower survival.

Why Is Robotic Mastectomy Worrisome?

Why is robotic surgery for breast cancer — and not for other cancers — such a great worry to Noorchashm? "It all comes down to trying to get a large specimen out of a small incision," he answered.

Traditional open mastectomy optimally results in the en bloc removal of a tumor — in one whole piece — to avoid fragmenting the cancerous tissue and possibly leaving residual disease behind. These events are associated with a higher risk for recurrence and treatment failure, he explained.

Noorchashm believes — but has no evidence — that robotic mastectomy may be especially susceptible to tissue fragmentation precisely because it uses a small incision, which is "a major selling point," he said.

However, New Jersey surgeon Chagares told the Philadelphia Inquirer in December that he believes the robot "does not pose a greater risk of fragmenting the tumor." The procedure is "the same technical mastectomy as I have been performing for 24 years, just using a scope for more accurate and magnified visualization," he said.

Patient advocate Noorchashm disagrees, saying the robot "radically changes the operation."

Critics and supporters agree that the robotic procedure takes longer and costs more, and there are as yet no long-term results.

The surgery was initially spearheaded by surgeons in Europe. It is currently the subject of a randomized trial in Italy, in which traditional mastectomy is the control arm. It is also being studied in a single-arm clinical trial in France.

In the United States, robotic mastectomy has not yet been studied in a clinical trial. However, investigators at the University of Texas MD Anderson Cancer Center in Houston told Medscape Medical News that they are planning to initiate a clinical trial "to study minimally invasive surgery for mastectomies in a select group of patients." Appropriate FDA clearances will be obtained prior to initiation, they said.

A Chicago-based surgeon believes the approach has great promise, including in community settings.

Barry Rosen, MD, a general surgeon at the Illinois Masonic Medical Center, told Medscape Medical News that nipple-sparing mastectomies are a "difficult operation" and that only a small percentage of general surgeons offer it, despite its desirability among patients.

Robotic breast surgery, with its inherent ability to avoid nipple removal, can overcome two obstacles that make the traditional nipple-sparing approach so challenging, said Rosen: "It is designed to put the surgeon's eyes into difficult-to-reach places and does not require forceful countertraction." The latter likely reduces the risk for skin necrosis, he added.

"Ultimately, I believe robotic mastectomy will help patients by opening the door to many more surgeons offering the [nipple-sparing] operation," said Rosen speculatively.

Rosen would prefer a trial setting for the initial usage in the United States.

A Very Different Vision

In 2018, another robotic mastectomy was performed, this time for prophylaxis for a patient who carried the BRCA mutation and was at high risk for breast cancer. The procedure was performed at the Long Island Jewish Medical Center, an academic center in New Hyde Park, New York. It does not appear that any other robotic mastectomies have taken place in the United States.

The procedure is not used for lumpectomies, pointed out Alice Yao, MD, a plastic surgeon who uses the da Vinci device for breast reconstructive surgery at Icahn School of Medicine at Mount Sinai in New York City.

"The incision [with lumpectomy] is already very small, so there is no benefit to the robot," she told Medscape Medical News.

Virtually all of the robotic breast surgeries performed in the United States are for breast reconstruction, not mastectomy, she emphasized.

Those robotic breast reconstructive surgeries are being performed by Yao at Mount Sinai as well as by surgeons at the University of Pennsylvania and MD Anderson.

"In breast reconstruction, the traditional skin incision can be 15 to 45 cm. In the robotic version, it is only 5 to 8 cm. This is a big deal in our field," said Yao, referring to plastic surgery.

Yao is one of only a small number of surgeons in the United States who is trained in robotic breast surgery.

Jesse Selber, MD, a plastic surgeon at MD Anderson who is a pioneer in robotically assisted plastic surgery, is another.

Robotic nipple-sparing mastectomy promises to reduce morbidity and improve cosmetic outcomes even further. Dr Jesse Selber

Selber, who trained Yao, has stated that robotic mastectomy is the future — for a subset of breast cancer patients who qualify. These would include women with smaller breasts.

In an editorial in the January issue of the Annals of Surgical Oncology, Selber writes that the nipple-sparing version of the procedure is the "next step" in the "evolution of minimally invasive breast surgery."

"Mastectomy has come a long way, and robotic nipple-sparing mastectomy promises to reduce morbidity and improve cosmetic outcomes even further," enthuses Selber.

The new approach was first described in 2015 and is "catching on in Europe, where early results have been very promising," he writes.

Selber says that low rates of conversion to open mastectomy and skin necrosis, as well as high patient satisfaction, "characterize early European experience."

Patient advocate Noorchashm knows Selber from the time they shared years ago as surgery residents at the University of Pennsylvania. He read Selber's new editorial and immediately wrote to the Texas-based surgeon.

"The fact that you are touting this procedure without really having any idea as to what the oncological outcomes of this radical change to the standard of care are going to be, is quite frankly shocking to me — especially from a place like MD Anderson," Noorchashm wrote last week in an email shared with Medscape Medical News and other news outlets.

Noorchashm raised the specter of a possible medical disaster with Selber, as he has to some extent in other recent letters to department heads at MD Anderson and to officials at the FDA.

He has not yet heard back from anyone other than the FDA, which acknowledged his communication.

Taiwanese Study

Selber's editorial in the Annals of Surgical Oncology accompanies a small retrospective study from Taiwan. That study involved 23 patients who underwent the robotic mastectomy procedure, followed by immediate breast reconstruction.

The study authors, led by Hung-Wen Lai, MD, PhD, of Changhua Christian Hospital in Taiwan, report that there have been no occurrences of nipple necrosis and no positive margins, and they say that all patients were satisfied with the procedure.

They also comment that the procedure "could be a promising new technique for breast cancer patients indicated for mastectomy."

In an additional comment, Lai summarizes that "women with small-to-medium-sized breasts, node-negative, and tumor located at upper outer quadrant with adequate skin to tumor distance (3 mm) are good candidates."

Notably, he calls for research with long-term follow-up "to confirm the oncologic safety" of the procedure.

Lai's study was funded by the Ministry of Science and Technology of Taiwan. The study authors have disclosed no relevant financial relationships. Selber, Noorchashm, Yao, and Rosen have disclosed no relevant financial relationships.

Ann Surg Oncol. 2019;26:42–52. Abstract, Editorial

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