Moving testimony about prolonged suffering and painful deaths caused by cancer that was spread during surgery performed with laparoscopic power morcellators may persuade the FDA to ban use of the surgical tool. The manufacturer, a division of Johnson & Johnson, has already recalled the device and the FDA has issued a warning that discourages doctors from using it. Some surgeons are refusing to heed the warning, potentially placing women at risk during hysterectomies and other procedures to remove uterine fibroids.
Why Surgeons Use Power Morcellators
At some point in their lives, most women develop uterine fibroids. They often produce no symptoms, but they can cause pain, prolonged menstruation, and excessive urination. Removing the uterus (hysterectomy) or the fibroids (myomectomy) is a surgical remedy that relieves women of those symptoms.
The laparoscopic power morcellator is a device that surgeons use to break up uterine tissue into pieces that can be extracted through a small incision. Compared to traditional surgical procedures, the minimally invasive surgery allows patients to recover more quickly and with less scarring.
The Risk of Morcellation
Despite its benefits, studies have concluded that using a power morcellator can cause hidden cancers to spread. Relying on a study published in a prominent medical journal, the Food and Drug Administration concluded that 1 in 350 women undergoing hysterectomy or myomectomy for presumed benign uterine fibroids have undetected cancers of the uterus. The power morcellator spreads those cancers within the abdomen and pelvis, shortening the lives of affected women and leading to agonizing deaths.
Elderly women and women who have a history of uterine cancer have the greatest risk of undetected cancer of the uterus. Physicians warn, however, that no reliable test exists to determine whether a patient who is contemplating gynecological surgery has cancerous cells that may be spread by morcellation. All women are therefore potentially at risk when power morcellators are used as a surgical tool.
The company that manufactures power morcellators initially responded to growing concerns about the safety of morcellation by implementing a moratorium on the sale of its product. As evidence of the risks of morcellation continued to mount, the company announced a recall of the product.
The FDA has not yet banned the sale of power morcellators for gynecological surgery. It may do so after further study or it may take other action, such as requiring doctors to warn patients of the risks associated with use of the product. The FDA may also require power morcellators to be sold with a warning, although product labeling may be insufficient to deter doctors from using a device that makes surgery easier to perform.
Pending further study, including hearings before an advisory panel of experts, the FDA is discouraging surgeons from using power morcellators to perform hysterectomies or myomectomies. The FDA strongly recommends that surgeons not use power morcellators whenever uterine cancer is known or suspected. The FDA also encourages doctors to review the risks of morcellation with patients and to explore alternative surgical procedures that are less likely to spread hidden cancers.
Some Surgeons Continue To Use Power Morcellators
Notwithstanding the product recall and the FDA warning, some surgeons continue to employ power morcellators when they perform hysterectomies and myomectomies. The Wall Street Journal reports that some doctors think the practice of medicine is none of the government’s business. One doctor, for example, has patients sign a disclosure that states the risk of hidden cancers is between 1 in 300 and 1 in 1,000, but admits that he undermines the disclosure by telling patients he does not believe those numbers are correct.
The FDA regulates medical products but it has no power to regulate the practice of medicine. One surgeon told the Wall Street Journal that doctors who disregard the FDA’s warning are playing Russian roulette with their patients’ lives.
What You Should Do If You Are Considering Gynecological Surgery
If a hysterectomy or myomectomy has been recommended for you, the FDA suggests that you consider other treatment options. In some cases, surgery is the best resolution of the problem. If an effective treatment alternative is available that would help you avoid surgery, you should give it serious consideration.
If you decide to undergo gynecological surgery, the FDA recommends that you ask your surgeon whether he or she intends to use a power morcellator. Have a frank discussion with your surgeon about the choice he or she is making to disregard the product recall and the FDA warning. Ask about traditional surgical procedures that do not involve morcellation. Whether or not you are satisfied with your surgeon’s explanation, get a second opinion from a physician who is not affiliated with your surgeon.
What You Should Do If You Had Gynecological Surgery
If you had a hysterectomy or myomectomy, tissues that were removed from your uterus were probably examined to determine whether they contained cancerous cells. If you did not receive the result of that test, ask for it. If the test was not performed, ask that it be conducted.
We hope that you are not the victim of a cancer that was spread by power morcellation. If you experienced that tragic result because a surgeon ignored FDA warnings, you may be entitled to compensation for pain and suffering and for the years of life you are likely to lose. Money will not replace those years but it will help you meet your medical expenses and live in relative comfort while giving you at least a small measure of justice.
The attorneys at Advocate Law Group have decades of experience handling product liability and personal injury claims. We work with leading product liability firms nationwide to help our clients obtain results. Contact us for a free case evaluation.