Couple That Fought to Ban Medical Procedure After Wife's Cancer Looks Back at Year of Changes

Major Blue Cross/Blue Shield plan will no longer cover procedure.

August 7, 2014, 4:23 AM

— -- After nearly a year of campaigning to ban a procedure favored by the medical community and dealing with his wife's life-threatening cancer diagnosis, Dr. Hooman Noorchashm said he finally feels his family is on solid ground again.

"We think we’ve landed on our feet. It’s been a whirlwind for almost the past year now," Noorchashm told ABC News.

Noorchashm, a cardio-thoracic surgeon, and his wife Dr. Amy Reed, a certified-anesthesiologist, spearheaded a campaign last fall to ban the practice of using laparoscopic power morcellation in the removal of uterine fibroids or the uterus due to possible cancer risks.

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The couple has first-hand knowledge of how devastating the procedure can be after Reed underwent the surgery last October to remove uterine fibroids. According to the couple and confirmed by Brigham and Women's Hospital, as Reed underwent the procedure—where the fibroids are broken up and removed through small incisions-- an undetected virulent cancer called leiomyosarcoma hidden in the fibroids was ground up along with the fibroids as they were removed.

As the device ground up fibroids for removal, it may have also spread the cancer throughout her abdomen.

Noorchashm told ABC News he was shocked and angry after hearing in detail how the procedure spread the undetected cancer.

"Within minutes of hearing of my wife's diagnosis. I just knew this was wrong," Noorchashm said of the procedure.

At the time of Reed's surgery, it was unclear what the likelihood a person undergoing the procedure would have undetected cancer.

A 2012 study published in the Public Library of Science found that in 1,091 morcellation procedures performed at Brigham and Women's Hospital over five years, only one woman was found to have leiomyosarcoma, the same virulent undetected cancer as Reed's.

Within weeks, Noorchashm was talking to other doctors and asking to get more information about these kinds of procedures and reaching out to other women who experienced something similar. He and Reed started a petition to get the U.S. Food and Drug Administration to ban the procedure.

Within months, two Boston hospitals, Massachusetts General Hospital and Brigham and Women’s Hospital (where Noorchashm was employed and Reed was treated), agreed to first review the procedures and then limit occasions when the procedures would be used.

But Noorchashm wanted a more permanent answer. He temporarily stopped working 90 hours a week as a surgeon at Brigham and Women’s Hospital in Boston and started applying that time to supporting his wife during her treatment and working to get the procedure banned.

"I basically used the same intensity I brought to work and focused it on this," said Noorchashm. "What you're seeing here is a large volume of time and non-stop sustained [work] in order to make a change."

In the months after Noorchashm and Reed started their petition, at least two medical articles were published in the Journal of American Medical Association questioning the safety of the procedure.

A study publish in July in the Journal of the American Medical Association by Columbia University researchers revealed that undetected uterine cancers were found in 27 per 10,000 women at the time of the procedure.

Last April, the couple had a major breakthrough after the FDA recommended doctors stop performing the procedure due to possible cancer risks. The FDA found that 1 in 350 women were at risk of having a type of uterine cancer, called uterine sarcoma, spread throughout the abdomen if they undergo the procedure.

In a statement sent to ABC News last April, the FDA acknowledged that Noorchashm brought the issue to their attention last December.

"After further discussion, we involved staff from across the agency to look into the issue further," the FDA told ABC News in a statement.

Despite the FDA caution, the American College of Obstetricians and Gynecologists released a statement in May that “minimally invasive surgery, including gynecologic power morcellation, continues to be an option for some patients undergoing hysterectomy or myomectomy."

The ACOG said that preoperative consults should be used to advise patients about their options and that further studies were required in the development of detecting uterine cancers before morcellation procedures.

Despite the ACOG findings, in recent weeks the procedure has become more and more marginalized after a major supplier withdrew devices for the procedure and a Blue Cross/Blue Shield insurance plan announced they would no longer cover the procedure due to potential cancer risks.

Late last month Ethicon, the Johnson and Johnson division that makes three device models used in these procedures, announced it is voluntarily withdrawing all of its power morcellation devices from the market.

According to an FDA spokesman, there are approximately 24 devices for laparoscopic tissue morcellators that have been approved by the FDA. The Johnson and Johnson withdrawal covers three devices on the market

"The risk-benefit assessment associated with the use of these devices in hysterectomy and myomectomy procedures for removing fibroids remains uncertain," Johnson and Johnson said in a statement. "Due to this continued uncertainty, Ethicon believes that a market withdrawal of Ethicon morcellation devices is the appropriate course of action at this time."

Noorchashm and Reed have not filed any lawsuit against either Ethicon or Brigham and Women’s hospital. The couple said they are focused instead on stopping the procedure altogether.

However, Ethicon’s morcellators are the subject of three lawsuits filed earlier this year against the company. In one case against Ethicon was dismissed after lawyers determined that a different manufacturer made the device used in the procedure. Ethicon has said they do not comment on litigation. According to an Ethicon spokesman, the cases are still pending.

The lawsuits were not a factor in withdrawing the devices, according to an Ethicon spokesman.

This week the Blue Cross/Blue Shield High Mark plan available to residents of Delaware, Pennsylvania, and West Virginia, announced it would no longer cover power morcellation for uterine procedures due to the possible risks.

For Noorchashm and Reed, both 41, the biggest news of the past year was not one published in a headline. Instead it was the news that after surgery and six rounds of chemotherapy Reed was found to have no evidence of disease.

In recent weeks the couple moved with their six children, aged 1 to 12, to Philadelphia, where their extended family lives and where Noorchashm will start at job at Thomas Jefferson University Hospitals later this summer.

Reed is likely to go back to work at some point in the next few weeks.

As the couple start to get back to their normal lives, Noorchashm said the last year has left a mark on how he practices medicine. He and Reed are still planning on working as advocates in different aspects of the field. And Noorchashm said he wants to change the way the FDA approves devices such as the morcellation devices.

Earlier this summer the couple were asked to talk at panel convened by the FDA to review the procedure.

In his day-to-day work, Noorchashm said he now puts himself in his patient’s shoes more often and doesn’t write off patients who seem disgruntled about something minor.

"Do I want that to happen to me or my loved one?" Noorchashm said of his new attitude. "[If] I wouldn’t want to be in that position, I'm not going to do that."

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