Power Morcellator FDA Warnings: A Summary

In 2014, the U.S. Food and Drug Administration began investigating the possibility of recalling the power morcellator, a tool that had long been popular with surgeons for minimally-invasive hysterectomies.

The investigation was spurred on by unsettling reports of women contracting advanced uterine cancer shortly after undergoing surgeries employing the device.

The FDA Alarmed by Morcellator Research

After an initial survey of available research regarding power morcellators and cancer-spreading risks, the FDA already saw a need to send out an urgent warning about the use of power morcellators.

Though the FDA has so far has stopped short of a complete recall/ban, the agency also issued a 2nd alert increasing the scope and intensity of its warnings against power morcellation.  These FDA warnings have caused significant fallout in the medical community.

What Did the FDA Warnings Say?

The power morcellator FDA warnings were issued in April 2014 and November 2014.  Both announcements were directed to a varied audience of surgeons, healthcare facility staff and administration, device manufacturers, and patients.  The contents are summarized below.

1st Warning:  Power Morcellator Can Jeopardize “Long-Term Survival”

This warning, sent out in April 2014, stated that the FDA “discourages” using the power morcellators for its leading application —  the treatment of uterine fibroids via laparoscopic hysterectomy or myomectomy.

The rationale behind this warning is twofold:  1)  If a power morcellator is used on cancerous tissue, it can spread cancer throughout the abdomen or pelvis, severely decreasing one’s “likelihood of long-term survival,” and 2) Uterine sarcoma, the type of cancer that morcellators have been reported to spread, cannot be reliably diagnosed prior to surgery.

Especially emphasized was the risk associated with morcellating in cases of suspected malignancy  or on patients possessing a number of risk factors for uterine cancer.   Healthcare professionals were advised to explore alternative treatment plans as well as other surgical methods, and to provide patients with comprehensive information on their options.  Patients were urged to perform research for themselves and to ask questions as well prior to deciding on surgery.

Also, based on its preliminary survey of current research and case studies, the FDA came up with a shocking new estimate of the prevalence of undiagnosed uterine sarcoma in patients seeking surgical treatment for uterine fibroids—1 in 350 women.  This is much higher than the 1 in 10,000 women figure that was commonly quoted prior to the release of this warning.

Panel Discusses Possible FDA Recall

To shed light on the pros and cons of enacting a power morcellator recall, the FDA held a comprehensive panel meeting on July 10 and 11, 2014, which had a diverse set of participants, including surgeons, gynecologists, pathologists, medical researchers, device manufacturers representatives, affected patients and family members of affected patients.

There were individuals on both sides of the debate—those strongly advocating for a power morcellator recall/ban, and those who felt that a complete ban would be a significant loss for patients and doctors.

Follow-Up Warning: FDA Against Morcellators for the “Majority of Women”

The FDA ultimately decided not to recall/ban the devices, but revised its warnings in November 2014 for further emphasis and a wider scope of application.

This follow-up warning was a new type of FDA communication—an Immediately-In-Effect (IIE) guidance, which indicates the urgency and importance of its contents.

In addition to reiterating the points from the April warning, the FDA expanded its advisory regarding the pool of patients considered eligible for power morcellation.

The agency now discouraged the use of the devices in the “majority of women,” suggesting that only a small number of special cases should be considered for power morcellator-aided surgeries.

The FDA also strongly advised manufacturers to include explicit warnings on their product labeling and advertising material, including a prominent “black box” warning.

Also new in this warning was an estimate of undetected uterine leiomyosarcoma in prospective hysterectomy/myomectomy patients –1 in 498 women, still about half of the original 1 in 10,000 risk estimate.

Fallout from the FDA Alerts

Even though the FDA has yet to ban/recall power morcellators completely, the agency’s warnings has  considerable response from influential individuals and entities in the healthcare, legislative, and legal fields.

Recall from Manufacturer Johnson & Johnson

After the FDA warnings surfaced, manufacturing giant Johnson & Johnson stopped distributing its power morcellator models across the globe.

Furthermore, the company later enacted a “voluntary market recall,” requesting that consumers return all previously-purchased morcellator products.

However, these actions did not silence critics or prevent litigation against the company.  Multiple lawsuits have been filed against Johnson & Johnson and other device manufacturers.

Johnson & Johnson even became the subject of an FBI investigation in early 2015, because of possible evidence regarding letters sent to the company mentioning power morcellator risks that may have been ignored.

Hospitals Restrict or Ban Morcellators

By early 2014, some hospitals chose to severely restrict the use of power morcellators unless containment bags were included.

A prominent example is Brigham and Women’s Hospital, where famous activist Amy Reed, who sent the FDA one of the first morcellator reports and still fights for a complete recall, had her morcellator-aided hysterectomy.

After the 2nd FDA warning was issued, a major national hospital chain, HCA Holdings Inc., completely banned the use of power morcellators.

Insurance Companies Exclude Coverage of Morcellator Surgeries

Insurance companies such as Blue Shield of California and Highmark, Inc. responded to the FDA warnings by retracting coverage for surgeries involving power morcellation,

By June 2015, Aetna and Health Care Service Corp, which are among the leading insurance companies in the nation, enacted similar policy changes.

State Legislators Pressure FDA and Push Constitutional Amendments

After meeting with Dr. Amy Reed and her husband Dr. Noorchashm about their tragic experience with power morcellators and their activist efforts, Pennsylvania Representative Mike Fitzpatrick and Senator Robert Casey urged the FDA to take reports of the devices more seriously.

Rep. Fitzpatrick and other lawmakers have pushed for several amendments to the legislative processes concerning “high risk” medical devices such as power morcellators, seeking improvement of approval, monitoring, and tracking laws.

So far, only one of the proposed amendments was passed.  This amendment introduces a system employing electronic health records for closely tracking medical device use.

Manufacturers Accused of Prior Knowledge

Though much public debate and action followed the release of these FDA warnings, a wave of lawsuits have been filed in which the plaintiffs claim that device manufacturers knew about the possible risks of power morcellators long before these alerts were issued.  They hold device manufactures liable for failing to adequately inform the medical community of the dangers inherent in their products.

If you or a loved one may have been harmed by the effects of a power morcellator, contact Monheit Law for a free case evaluation.  We will consider the details of your case and work for you on a contingency-fee basis if you decide to pursue legal action—you pay nothing until a settlement is secured in your favor.