FDA Says Surgical Device May Spread Cancer
April 17, 2014, the FDA warned surgeons not to use laparoscopic power morcellation during a hysterectomy or fibroid removal procedure, because it may spread undetected cancer.
“Based on an analysis of currently available data, the FDA has determined that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer called uterine sarcoma,” a press release stated. “If laparoscopic power morcellation is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.”
In February, obmanagement.com said fibroids are “the most common pelvic tumor among women” and are one of the two most common reasons to undergo a hysterectomy but cautioned that morcellation “permits small bits of tissue to spread around the peritoneal cavity.”
Additionally, uterine leiomyosarcomas are sometimes mistaken for fibroids. If that tumor is morcellated, said Editor in Chief Robert L. Barbieri, MD, “bits of tissue can be spread, upstaging the tumor and worsening the prognosis.” That could mean the difference between a 73 percent survival rate and a 46 percent survival rate after five years, according to a study he cited.
“One approach to reducing the pitfall of open power morcellation is to place the uterine tumor in a bag, hand morcellate the tissue within the bag, and remove the bag and tissue through an abdominal incision (mini-laparotomy) or a colpotomy,” Barbieri stated.
If Morcellation Is Dangerous, Why Did the FDA Approve It in the First Place?
As nytimes.com blogger Jane Brody said in March, “Many patients assume that, like prescription drugs, surgical procedures and instruments undergo extensive testing and must be government-approved. … Surgical techniques, however, are not subject to the stringent approval process that drugs go through. And as with drugs, problems with new procedures may not become apparent until after they have been used many hundreds or thousands of times.”
According to the American Association of Gynecologic Laparoscopists (AAGL), the FDA approved the first morcellation device May 25, 1995 under its 510(k) process, which only requires medical device manufacturers to show that their product is similar to one that is already on the market.
“Advocates for the minimally invasive treatment argue that it is beneficial for most women with fibroids because it reduces the risk of complications from open surgery and reduces recovery time,” washingtonpost.com stated July 9.
But many women, including one whose 56-year-old sister died four months after surgery, doesn’t believe the procedure is worth the risks.
“What are two small incisions or a speedy recovery worth when you’re dead?” she asked.
Speaking on behalf of Johnson & Johnson subsidiary Ethicon, Matthew Johnson told WP reporters that the company’s morcellation devices “have always included cautions in their instructions for use about the potential spread of malignant (or suspected malignant) tissue.”
A Cleveland Clinic gynecologist said the facility has known about the risk but continued to use the surgical instrument until the FDA’s April warning.
“We can support suspending the device until we find out what’s safest for our patients, but I don’t think it should be eradicated,” she said. “We need to educate patients of the risks and offer alternatives to this technique.”
If you believe surgical morcellation caused cancer after a hysterectomy or myomectomy, attorney Chris Mellino welcomes you to contact our Cleveland office for a free consultation before Ohio’s statute of limitations expires in your potential claim. You can learn more about Mellino Law Firm by reading testimonials and a sampling of case results. You may also download Chris’ free, easy-to-read guide on filing a medical malpractice claim.