If Laparoscopic Power Morcellation Is Unsafe, Why Does the FDA Allow It?

December 21, 2014, 8:00AM. By Gordon Gibb

Washington, DCWhen pharmaceutical and medical device giant Johnson & Johnson (J&J) suspended sales of its Ethicon Laparoscopic Power Morcellation system as a precaution following an FDA safety bulletin and concerns over the inadvertent spread of unknown cancers within a woman’s body, the move has proven more than merely prudent. Caution and concern, over the ensuing months since April have escalated, rather than diminished.

It also gives one pause to wonder about the dark side of minimally invasive laparoscopic surgical techniques that reduce scarring, speed healing and minimize pressure upon hospital resources. For many women, treatments for fibroids involving power morcellation have done more harm than good.

Power morcellation, as the preceding suggests, has until now been a popular, latter-day method of busting fibroids and undertaking other common procedures unique to women - including hysterectomy. Rather than a more invasive procedure involving a much larger incision, surgeons use the power morcellation tool to break up fibroids and other unwanted tissue through a tiny incision. The fragments are then extracted through the incision.

While there is less scarring and faster healing, concern has been growing about the inadvertent spreading of previously undetected cancers. Still others have been besieged with benign tumor growth and other unwanted masses that have required surgical intervention. Various plaintiffs, who have been treated in this fashion for fibroids or laparoscopic power morcellation hysterectomy, are pursuing legal action.

What the FDA says…

For its part, the US Food and Drug Administration (FDA), following the issuance of a safety bulletin this past April, convened an expert panel over the summer. The panelists concluded there is no safe way to use Laparoscopic Power Morcellation - an interesting finding, given the FDA position on most drugs and medical devices that a product is considered “safe,” or “not unsafe” provided the benefits outweigh the risks for the intended indication and patient.

The panel, it has been reported, could not agree however on whether or not power morcellation as a procedure should be recalled. The FDA response to the standoff has been the issuance of a black box warning over the potential for spreading unknown and undetected cancers. There are also new contraindications for the procedure.

Thus, power morcellation has not been recalled. Instead, a black box warning has been issued together with contraindications, and a stance from the FDA that suggests, as above, there is no safe way in which to undertake power morcellation. Put another way, power morcellation is unsafe - but still available through informed consent.

Such cautions and warnings do little to help the thousands of women who have undergone fibroid eradication, hysterectomy or laparoscopic power morcellation myomectomy each year - as many as 500,000 procedures. Estimates are that one in 350 power morcellation patients may have unsuspected sarcoma prior to their procedure.

Women are at risk

If that’s the case, power morcellation can foster the spread of the unknown cancer. And a recent study appears to back this up.

Researchers for Kaiser Permanente, one of the largest health providers in the country, conducted a retrospective review of 3,523 women who underwent laparoscopic hysterectomy between 2001 and 2012. Findings appeared online in the American Journal of Obstetrics & Gynecology (12/11/14) earlier this month. Out of 941 patients who underwent the uterine fibroid treatment involving laparoscopic power morcellation, 10 women - or 1.1 percent of the study participants - were later diagnosed with uterine sarcomas or parasitic myomas. Six of those had uterine sarcoma.

“There was no association between any of the factors analyzed and uterine sarcoma,” the researchers determined. “Uterine sarcoma was found in 0.6 percent of patients who underwent power morcellation but was not found to be significantly associated with any preoperative factors. Patients should be counseled about these complications prior to power morcellation.”

Yet another report, appearing online December 5 in Obstetrics & Gynecology, chronicles the experiences of three women who battled benign uterine disease - including massive tumor growth - following what many now characterize as one of the dangerous medical procedures of our time.

One subject, a 51-year-old mother of two, was found to have developed a 15 centimeter (5.3 inches) abdominal mass that adhered to parts of her ureters, bladder, colon, omentum, left ovary and fallopian tube, all of which had to be resectioned to remove the mass. The patient was found to have suffered abdominal pain, painful urination and pressure on her pelvis.

“Each woman required a laparotomy and extensive, multiorgan resection to clear the disease,” the researchers noted. “Even in the setting of benign conditions, open power morcellation of the uterus may be associated with clinically significant dissemination of uterine disease.”

FDA no longer considers laparoscopic power morcellation as safe

In the spring, when the FDA issued its initial caution and J&J’s Ethicon unit temporarily halted sales and manufacture of its power morcellation device, many hospitals stopped using power morcellation. Still others would only undertake the procedure if an internal bag was used to isolate tissue fragments as a precaution.

Everyone has been waiting for further direction from the FDA, in order to proceed. The FDA - for now - is satisfied with a strong black box warning and contraindications, together with the position that in its view (a view reflected by expert panelists who met in July) power morcellation cannot be undertaken safely.

That said, such treatments for fibroids as power morcellation can proceed, given the addition of the black box warning, provided there is informed consent.

It remains to be seen what impact the FDA’s stance - basically, a measured support and allowance of a procedure the agency feels is no longer safe - will have on pending Laparoscopic Power Morcellation litigation.