Updated March 18, 2013, at 2:15 p.m. with a correction.
A group of surgeons over the weekend issued a public letter chiding American College of Obstetricians & Gynecologists president Dr. James Breeden over an editorial highlighting cost concerns and a perceived lack of evidence behind the hype around robot-assisted procedures.
"We see a failure in ACOG’s ability to embrace the education of minimally invasive surgery," the doctors wrote. "Robotic surgery is an enabling technology that has transformed our ability to operate in a more efficient, controlled surgical field and master complex anatomical environments. It has allowed us to extend a level of quality surgical care to our patients that is exceptionally more diverse and complete than was ever possible with traditional methods of surgery."
The letter came in response to Breeden’s letter, published last week by ACOG, which called into question the cost-to-benefit ratio for expensive robot-assisted surgical procedures.
"While there may be some advantages to the use of robotics in complex hysterectomies, especially for cancer operations that require extensive surgery and removal of lymph nodes, studies have shown that adding this expensive technology for routine surgical care does not improve patient outcomes," Breeden wrote. "Consequently, there is no good data proving that robotic hysterectomy is even as good as – let alone better – than existing, and far less costly, minimally invasive alternatives."
Robots in the operating room are generally connected with lower recovery times, but the technology often requires expensive instruments, and the systems themselves come with a heavy price tag. Breeden’s letter was not the 1st to call out the technology for its extra expense and perceived lack of sufficient clinical evidence.* Some doctors and rival device makers have criticized the lack of sufficient clinical data directly comparing robot-assisted surgery to other minimally invasive procedures.
The coalition of doctors defending robot-assisted surgery called Breeden out for "the lack of evidence" that they claimed underpinned the ACOG letter. Breeden compared robot-assisted surgery to other minimally invasive procedures, but the coalition claimed that most physicians can’t offer such approaches to their patients.
Breeden’s comments, the coalition said, addressed cost concerns that hadn’t properly been studied and failed to consider the indirect costs, such as extended hospital stays and time away from work, associated with traditional procedures. Robotic systems have "enabled minimally invasive surgery for nearly every 1 of our patients, and >100,000 more women were offered a minimally invasive hysterectomy in 2012 as compared to 2005 as a direct result of the robotic platform," according to the letter.
Breeden’s letter helped spur another in a string of sell-offs for Intuitive Surgical’s shares, but it’s conclusions were very similar to those published earlier in the Journal of the American Medical Assn. That report questioned the value of robot-assisted hysterectomy in terms of the increased cost and the benefit to patients.
"Because both laparoscopic and robotic-assisted hysterectomy are associated with low complication rates, it is unclear what benefits robotically assisted hysterectomy offers," according to the February report. "When the innovation being advertised is of questionable advantage, direct-to-consumer promotion may only fuel unnecessary utilization."
The coalition of doctors took exception to indications that the rise of robot-assisted surgery was due in any way to "deceptive marketing practices," calling the notion an affront to physicians and their informed clinical opinions.
The group concluded by asking ACOG to "reflect upon your statement and reconsider an opinion based on incomplete data," calling on other minimally invasive physicians to help shore up the holes in research surrounding robot-assisted surgery.
"In the light of the recent flurry of negative news based on the early experience with robotic surgery, we robotic surgeons are now compelled to collaborate and produce outcomes research to document the benefits we are seeing clinically and to comprehensively evaluate the "cost" of this technology," according to the letter.
Neither Breeden’s letter nor the response mentioned Intuitive Surgical by name, but the company is generally perceived as the face of robot-assisted surgery. Intuitive Surgical’s da Vinci system has a corner on much of the market, including minimally invasive hysterectomies and prostatectomies.
The medical device company has had a run of bad luck lately as a few stark headlines dragged shares down more than 20% over the course of this month. ISRG shares dropped 11% in 1 day on February 28 on news that the FDA was conducting a survey of da Vinci robot users, asking for details about an apparent rise in complications associated with the device and seeking tips on best use and training.
Intuitive Surgical later explained that what appeared to be a rise in da Vinci complication rates was actually a reflection of new reporting practices rather than a change in product performance.
"In September 2012, Intuitive Surgical revised its [Medical Device Reports] practices, resulting in increased reports of device malfunction MDRs, the vast majority of which were related to instruments and not to systems," the company said. "None of these device malfunction MDRs involved reportable injuries or deaths."
Analysts at Goldman Sachs also came to the defense of the company, maintaining a "buy" rating on ISRG shares and projecting an end to the nosedive that dragged the stock price down nearly 20% since the end of February. ISRG shares opened at $573.44 on February 28, but sank to $509.89 by the end of the day on news of the FDA probe. Shares have bounced up and down over the course of the month, closing at $459.44 on Friday, March 16.
The physician defense and the positive analyst outlook may have helped turn the tide. Shares gain 4.4% today and were trading at $479.40 as of about 11:40 a.m. EST.
The plunge, while bad news for current shareholders, may be an opportunity for new investors.
"ISRG is extremely oversold and represents an incredible buying opportunity," according to StockTalks at SeekingAlpha.com. "The recent sell-off is due to fear, and when the truth behind these fears is realized, the stock will undoubtedly rise."
*Correction: This article mistakenly stated that the da Vinci surgical system’s instruments are designed for 1-time use. Most are usable 10 times prior to replacement, according to the company.