FDA Warns of Uterine Cancer Risk for Hysterectomy, Myomectomy

FDA Warns of Uterine Cancer Risk for Hysterectomy, Myomectomy | Pintas & Mullins Law Firm

Women who undergo hysterectomies or myomectomies using a specific medical device called a power morcellator are at significant risk of developing uterine cancer. The FDA and several news outlets are releasing safety updates to women who are thinking of having these surgeries. Uterine cancer lawyers at Pintas & Mullins Law Firm are currently investigating cases involving power morcellator devices.

The link between uterine cancer and these medical devices was just recently discovered and confirmed by several studies; one of which found that women who underwent surgeries with power morcellators were 20-30% more likely to suffer uterine cancer than those who did not have such surgeries. In response to these findings, the FDA released a Safety Communication on April 17, 2014, and again on November 24, 2014.

The FDA estimates that 1 in every 350 women who undergo a hysterectomy or myomectomy have undetected uterine cancer.

Power Morcellators

These medical devices are used during different types of minimally invasive (laparoscopic) procedures, such as to remove uterine fibroids or the uterus. Power morcellators work by breaking uterine tissue into small pieces or fragments, to make removal easier. When these devices are used in women with uterine fibroids, power morcellators can spread and seed undetected uterine cancer tissue.

What makes this so dangerous is that there is no way to reliably detect cancerous tissue in uterine fibroids. If a power morcellator is used on a woman with undetected cancer, there is a serious risk that the surgery will spread cancer throughout the abdomen and pelvis, significantly worsening her chance of long-term survival.

Because there are many alternative options for women who need a hysterectomy or myomectomy, the FDA is now urging against the use of power morcellators in most women. Johnson & Johnson has pulled three of its power morcellators from global markets, and many top hospitals have banned them.

Uterine Fibroids

Most women develop uterine fibroids at some point, often during pregnancy, and they can range in size from undetectable to bulky masses. Many fibroids do not cause any symptoms and go away on their own, while others cause serious symptoms. Among the most common are:

• Heavy or prolonged menstrual bleeding • Frequent or difficult urination • Pelvic pressure or pain • Constipation 
• Backache or leg pains • Enlarged uterus and abdomen

Many women who need to have their uterus or uterine fibroids removed choose laparoscopic surgeries with power morcellators because they are associated with shorter recover times and less risk of infection. Now that the cancer risks are known, however, doctors need to inform their patients about the risk of spreading undetected cancer.

Cancer experts state that there is a far greater chance of full recovery and survival if surgeons remove the uterus intact, instead of with a morcellator through small incisions. This means a more invasive surgery, but a much better chance of beating uterine cancer. Once cancer spreads, it is far less likely to be cured, and morcellators spread tissue like wildfire.

For too many women, these warnings are too late. Linda Interlichia, who underwent a hysterectomy in 2013, was recently profiled by the Wall Street Journal. Linda was diagnosed with aggressive uterine cancer (leiomyosarcoma) after her surgery, which was performed using a power morcellator. She was never told that her surgery would involve a morcellator.

Eight weeks after her surgery, a doctor found a softball-sized mass of tumors in her pelvis that were not there before her surgery. Cancerous fragments left behind after morcellation had embedded in her abdomen, spreading widely. The hospital where she underwent the surgery has suspended power morcellation. Linda died on Halloween of this year, at age 55. 

Alarmingly, some doctors are still using power morcellators, insisting that the FDA was overreaching and the media attention was sensationalistic. This seems ridiculous, particularly because there are perfectly safe alternatives to power morcellator surgeries, and the cancer risk is so severe and in many cases deadly. The fact is, there is no safe way to offer power morcellation hysterectomies or myomectomies. 1 in 350 women have undetected cancer, and there is no way to test for cancer before the surgery.

Our team of uterine cancer lawyers is currently accepting cases of cancer diagnoses after these types of surgeries. If you or someone you love was diagnosed with uterine or ovarian cancer, contact our firm immediately. You do not have to know for sure if power morcellators were used in your procedure, we investigate that for you so you can focus on getting well. Our consultations are always free and available to concerned parties nationwide.