FDA Discourages Common Medical Procedure in Women, Warning About Risk of Spreading Cancer
It's a relatively common medical procedure, but now the FDA is discouraging it, saying it could spread an undetected, deadly form of cancer. Unfortunately some, including a Sacramento woman, have already lost their lives.
"We were very good friends. She was my best friend," says Joanne Jacobson, while looking back at pictures of her sister, Elizabeth.
She says Elizabeth could still be here.
"My sister was collateral damage," said Jacobson.
Elizabeth, a Sacramento lawyer, died less than a year after having a hysterectomy using what's called a power morcellator. It's a laparoscopic tool used to cut up tissue and pull it out in pieces, meant for a more minimally-invasive surgery.
"Had we known, we would have made sure that, you know, that she hadn't had this procedure done," said Jacobson.
Elizabeth came from a medical family, with her dad and two sisters all doctors, but none of them knew the risks posed by the procedure.
The problem, according to the FDA is about one in 350 women who have this kind of surgery have an unsuspected type of uterine cancer.
The FDA now warns that use of the laparoscopic tool, on some cancerous uterine tumors, risks spreading the cancer and decreases a woman's chance of survival.
That's what Jacobson says happened to Elizabeth.
"The hard part was just watching her suffer so horribly," said Jacobson. "She didn't want to give up. She said, 'I don't want, I'm not ready to die.'"
Elizabeth lost her fight January 8th, 2013 at the age of 55. There are others who have suffered a similar fate.
"I don't know why it happened. I don't know why a morcellator had to be used. I am angry, I am sad," said Scott Burkhart.
His family in Pennsylvania is now taking legal action following the death of Burkhart's wife, Donna, which they also blame on the spread of cancer from this type of hysterectomy.
Boston couple Amy Reed and Hooman Noorchashm, both doctors, started a Change.org petition to ban this procedure after Amy had it. She's now battling stage-four cancer.
"I would like to think we are speaking for all the thousands of women who don't know where to turn or are told just like we were told initially, that I am sorry, you have cancer. And that unspoken part of that is do I just go home and die?" said Reed.
Now the FDA has stepped in, and just last month discouraged the use of the device for removing the uterus and fibroids while it reviews exactly how it should be used.
"We are heeding the FDA warning and reassessing our entire practice based on the new warnings that are out there," said Dr. Behy Nejad, an OB/GYN with UC Davis.
Dr. Nejad says patient safety is their first priority. And while doctors aren't stopping these surgeries altogether, they'll likely now operate with the uterus in a bag to contain any potential cancerous tissue, and be very selective about who should still use this method.
"Patient consent is really important. Just really making sure the patient understands the risks and benefits of the procedure. And some people may choose not to have a morcellator procedure or they might choose to have a traditional hysterectomy," said Dr. Nejad.
UC Davis did not perform Elizabeth Jacobson's surgery.
CBS13 contacted the other major hospital systems in our area.
Dignity Health gave us the following statement:
Our top priority is the care and safety of our patients. Dignity Health is working collaboratively with physicians and actively heeding the cautions and recommendations provided by the FDA regarding the use of laparoscopic power morcellation during hysterectomies for the treatment of women with uterine fibroids.
Sutter Health gave us the following statement:
Medical experts across the nation are thoroughly reviewing the benefits and risks of this procedure. We understand that women may have questions based on the recent FDA announcement. Sutter Health's priority is providing patients with personalized, quality care. We encourage women with talk to their doctors and ask specific questions about available options so they can make informed decisions about treatments best suited for them. We also encourage women to visit the FDA and American Congress of Obstetrics and Gynecology websites.
Kaiser Permanente gave us the following statement:
Meeting the needs of our patients with health care that is safe, reliable and high quality is of the utmost priority at Kaiser Permanente. We treat the needs of our patients individually through joint decision making between patient and physician, continually evaluate the latest evidence and treatment protocols, and use our data to help women make educated decisions in the best interest of their own health. We are currently evaluating the FDA's recommendation around the use of laparoscopic power morcellators during different types of laparoscopic procedures, specifically hysterectomy or myomectomy for uterine fibroids, in order to deliver the best treatment options for the needs of our patients.
Jacobson thinks the FDA warning is a good first step and hopes an all-out ban is coming.
"We can't bring her back," said Jacobson, "But you know, hopefully this isn't going to happen to somebody else."
Just this week, one of the manufacturers of the morcellators, Johnson and Johnson suspended its sales of the devices until they say the device's role in fibroid treatment is better understood.
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