40-27 Harvard Physician Whose Cancer Was Spread Through Morcellation Seeks to Revamp FDA Regulation of Medical Devices 2

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Harvard Physician Whose Cancer Was Spread Through Morcellation Seeks to Revamp FDA Regulation of Medical Devices

On The Principles of Surgery

Noorchashm attributes his wife’s complication in part to deficits in the gynecologists’ surgical training.

“Gynecologists as a whole are not trained in general surgery at all, and they thought that it’s okay to morcellate,” Noorchashm said. “Really, no other surgical specialty does this. Some urologists here and there morcellate things, but as a systemic practice, it’s nowhere practiced like gynecologists do it.

“In fact, general surgeons and oncologic surgeons never do it for this reason—because there’s concern that cancer would spread. But these guys have systematized it as a routine, and they think it’s okay.

“And the reason for that is because they don’t get any training in the fundamental principles of general surgery. During their residency, they take no time to do general surgical training, which is different from all other surgeons, who spend, at least, a minimum of a year doing general surgery training.

“The next thing is I think they are not looking at it correctly, meaning, they were looking at it as a one in 10,000 to 20,000 event, and they were saying, ‘Oh, that’s acceptable, I guess.’ I don’t think that’s acceptable anyway.

“Who’s going to pick who that one in 10,000 is going to be? And that is why oncologic surgeons and thoracic surgeons never do that.

“They were looking at the wrong denominator—it should be the subset of women with symptomatic fibroids, not the general population.”

MD Anderson’s Brown said risk cannot be eliminated, regardless of surgical procedure.

“I think that every area of surgery and every area of patient care is unique,” Brown said. “There are, however, lower-risk procedures than others. The issue centers around comparative risk in the population of women who are candidates for surgery that could include morcellation.”

It’s unfair to compare gynecologists with oncologists and other surgeons, BWH’s Bertagnolli said.

“It is very unfortunate to label a field in a negative way over an issue such as this,” she said. “Instead, we should emphasize more inter-disciplinary education. In a case such as this one, close communication between the oncology and general gynecology communities is a key requirement for reducing morbidity and deaths due to uterine sarcomas.”

Sugarbaker, from MedStar Washington Hospital Center, said oncologists generally do not deal with specimens as large as fibroids.

“Some of these things are as big as a woman’s head—they’re gigantic,” Sugarbaker said. “I’ve removed fibroids that weigh 10 pounds. But I’m seeing this woman who had power morcellation a year ago. They didn’t even make the diagnosis of sarcoma.

“The pathologist looked at the morcellated specimens that were removed and no sarcoma was detected, until she got a recurrency. There’s no doubt that it was spread by power morcellation—100 percent. She’s now got a 12 cm mass in the right lower quadrant. This thing has grown quite rapidly over the course of a year and a half.

“Then and only then did they make a diagnosis, and that’s because the fibroid was 99 percent benign, but they cut through the small focus of malignancy. And even though the pathologist didn’t see it when he examined the specimen, the sarcoma grew out 18 months later. Now I’m going to have a big surgery to try and get rid of it, and there’ll be large nodules and a lot of small nodules.

“From my perspective, if indeed there is a disaster—a fibroid gets morcellated and it has a sarcoma in it—that patient needs immediate referral to a peritoneal surface oncology treatment center, and there are 20 or so of them around the country. That doesn’t mean they’re not going to develop disease in their lungs, but I think we can prevent a small volume of the disease from growing out on their peritoneal surfaces.”

Morcellation is not an option in general surgery, said Kaiser, a thoracic surgeon at Temple University.

“The safest thing is not to do it; again, I am not a gynecologist, I don’t do this,” Kaiser said. “But I can tell you, in general surgery and in chest surgery, we would never morcellate. We do everything we can to remove specimens intact. It goes against surgical principles to chop something up inside a body cavity.

“I think that if a surgeon is going to do it, there needs to be fully informed consent. The woman needs to know there is a small chance they could be spreading cancer. And if they agree to that, they can go ahead and do it, recognizing what the risks are. But I think, from a policy standpoint, the safest thing is, don’t do it. Surgical principles are surgical principles, no matter what the specialty is.”

“On the other hand, there clearly are some differences. We also, in the non-GYN world, there are not a whole lot of indications to do debulking type procedures, which they have been very successful at in ovarian cancer. There are very few other procedures where we do any sort of debulking procedure.”

The Risk-Benefit Debate

Nearly half of minimally invasive hysterectomies, and over 80 percent of myomectomies are performed robotically and laparoscopically.

“This is a very lucrative practice,” Noorchashm said. “The procedure itself bills $30,000 to $50,000, depending on the center. I can tell you that when a patient gets discharged on the same day, she doesn’t have all the liability risks that they incur by keeping a patient in the hospital for a day or two because of an open operation.

“That’s probably in terms of both liability as well as costs that are probably left as a margin for the hospital and the doctor.”

Gynecologists say the procedure shouldn’t be eliminated.

“I think the AAGL has taken a very careful stance on this issue, making sure that we put together all of the appropriate information and very meticulously analyze this for the benefit of our patients,” Brown said. “We convened a 12-member task force of people who got together, face to face, reviewed every piece of literature and data that we have regarding tissue extraction and uterine morcellation, specifically with regard to power morcellation in order to synthesize all of those data, and really review risks and benefits for patients in various circumstances.

“And at this point, based on those data, the AAGL has not recommended elimination of power morcellation as a procedure, but instead suggest that it be individually considered.

“The procedure itself—hysterectomy—is of course very common. The issue with large fibroids is also very common. When we are looking at risks and benefits of different procedures, it is a very difficult set of risks and benefits to balance.

“We are looking at the possible rare, very adverse event of an undetected leiomyosarcoma, compared with the potential adverse events compared to minimally invasive surgery. That’s why this isn’t an easy answer.

“What you may recognize is that what we are talking about here is a huge number of women that need to undergo a hysterectomy for uterine fibroids and essentially about 77 percent of women that undergo a hysterectomy have some evidence of fibroids in their specimen. The numbers we are talking about, 600,000 women a year, and 77 percent of those have some fibroids. It’s a large denominator of women we are looking at.”

BWH’s Bertagnolli concurs that the data are insufficient for a risk-benefit assessment.

“Unfortunately, an accurate understanding of the risk is just not possible with the data we have,” she said. “I agree with those figures, anywhere from 1 in 350 to 1 in 1,000; we just don’t know. In my mind, even one woman is too many; of course, we never want to see this happen.”

Gynecologists should instead focus on the fact that power morcellation can be avoided, Noorchashm said.

“Morcellation is totally avoidable, and its victims unidentifiable pre-operatively,” he said. “Therefore, the death it imposes is not accidental. It is systematic and victimizes the minority subset of women with occult or missed uterine cancers.”

There are safe alternatives that do not involve morcellation of potentially malignant tissue, Kaiser said.

“I think [the argument that power morcellation lowers risk and has more benefits than open surgery] is a specious argument,” Kaiser said. “We did open surgery for an awful lot of years, and if you do a laparoscopic approach and the last thing you have to do is make a little larger incision in order to do this thing, you haven’t put any kind of spreader in there, it’s highly likely that the patient isn’t going to have that much additional pain.

“It can be removed through the vagina as well, if you have done a total hysterectomy, because you have got to close the vaginal cuff so, now if the specimen is too big, then it’s difficult to remove it that way, you can make a larger incision.

“It comes down to fully informed consent. If a woman is told, ‘Look, we are going to chop this thing up to save any sort of incision, there is a chance we could be chopping up a tumor, in which case it would put you at very high risk of spreading your cancer through the peritoneal cavity.’

“I don’t think all that many women would say, ‘Yeah go ahead and do that.’”

Informed consent does not protect the patient, Noorchashm said.

“How does informed consent about the mortality risk protect the patient from the spread of an occult or missed uterine cancers via morcellation? It doesn’t!” he said. “It’s at best a feeble attempt at medically and legally protecting an industry and, at worst, ethical negligence on the part of doctors who should know better.”

Reed: Change Will Happen

Several senators have been responsive to Noorchashm’s cause.

“All the U.S. senators are aware of this issue,” he said. “Congress can put pressure on FDA to ban the devices.

“The Senate has a responsibility to set a hearing. The 510(k) deficit is one of the main reasons why my family has fallen to morcellation. The 510k process needs to be revised, and that’s something I’m working on with Sen. Elizabeth Warren’s [D-Mass.] office. And I think the morcellator is only one prominent example of a systemic problem with what the FDA classifies as type 2 devices.”

The FDA hearing July 10 and 11 is an opportunity to discuss potential legislation, Challoner said. A statement he submitted to the agency reads:

“After nearly four decades, at a time of rapidly changing science and technology questions persist about whether the 510(k) process is protecting the public’s health. Unfortunately, the sad saga of the evolution and modification of morcellation devices for gynecologic use under 510(k) clearance adds yet another example to the need to reconsider the safety and public health protection of this process.

“There is great difficulty in detecting many device failures because of our inability to detect, suspect, and report ‘weak’ or rare signals from the clinical environment. That also appears to have contributed to the current issue of morcellation of malignant gynecologic tumors. These incidents should give us pause and urge the FDA once again to begin the conversations the committee recommended in our report.

“The passage of time and the appearance of new information technologies give the opportunity to shorten evaluation times premarket with appropriate engineering and product planning which industry should support.”

Noorchashm and Reed said their goal from the outset was to ban the medical practice and the specific set of devices used to perform it.

“This campaign is not a personal attack,” Noorchashm said. “I believe that this is an industry-wide act of ignorance and a major error in medical judgment. They weren’t aware that there was such a risk, because of how they train. They hadn’t thought about it critically enough and unfortunately an industry evolved around it. But now that they are aware, continuing it in any form constitutes deliberate and prosecutable negligence.”

Common sense will prevail, Reed said to The Cancer Letter.

“I’m optimistic,” she said. “I think it’s human nature to resist change, and I think that’s sort of what we’re encountering.

“As physicians, we do want what’s best for our patients, and I believe that even the gynecologists who are morcellating think that’s best for their patients.

“And it will take time to push them in a direction of change, and maybe not even them, but the generations to come so you can be sure that GYNs in training right now, this is on their plate.

“I think change will happen,” she said.

Noorchashm and Reed will be leaving Harvard Medical School and Boston with their six children, ages one to 12, to be near their extended family in Philadelphia.

Noorchashm will serve as a cardiac surgeon at Thomas Jefferson University Hospital, and Reed is negotiating with another academic medical center.

Tessa Vellek and Will Craft contributed to this story.

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