Laparoscopic power morcellators have garnered a negative reputation in recent years as being far more dangerous than they are useful. But why? What do morcellators do that has the Food and Drug Administration (FDA) worried and doctors across the country extremely hesitant to even get near one of the devices? To get to the bottom of the issue, there are a few frequently asked questions about power morcellators that should be answered:
What is a power morcellator?
A laparoscopic power morcellator is a handheld surgical tool that is meant to assist doctors break large pieces of infected or dead tissue within the uterus into smaller pieces that can be removed more easily. The idea seems sound in concept and proved helpful in minimally invasive hysterectomies and myomectomies. But the dangers of morcellation comes not initially but after some time later.
What is the danger a power morcellator causes?
According to the FDA, at least 1 in every 350 women have undiagnosed uterine cancer, which forms in tumors that look strikingly similar to less dangerous fibroids. If a morcellator is used to cut up and remove a fibroid that is actually a cancerous tumor, it can actually hasten the spread of the cancer by physically dislodging cancerous portions and displacing them throughout the uterus.
Who is Amy Reed?
You may have first heard about morcellator dangers in 2013 when Boston’s Brigham and Women’s Hospital stated that a power morcellator had noticeably worsened anesthesiologist Amy Reed’s cancer. The case grew in controversy after the hospital denied any responsibility after Ms. Reed brought a lawsuit against them.
What is the FDA doing about power morcellators?
In early 2014, the FDA made a clear statement to doctors and surgeons everywhere to avoid using laparoscopic power morcellators except in cases when it is absolutely necessary. It was not an outright ban but it may as well have been as it placed morcellators in an unflattering light. Later that year, the FDA ordered manufacturers of morcellators to put a “black box” warning label on the products – the same kind of warning found on cigarettes and other notoriously dangerous substances.
Are there alternatives to morcellation?
Part of the reason advocates for patient health and safety are so frustrated by power morcellator dangers is that there has always been alternatives to morcellation. The surgical tools were primarily used to hasten recovery time and reduce the incision necessary for a hysterectomy. Doctors are returning to safer alternatives, such as a mini-laparotomy, in light of the FDA’s black box label.
Can I sue if a morcellator has caused me harm?
Yes. Ever since Amy Reed’s case in 2013, many more morcellator lawsuits have come to light. Pharmaceutical giant Johnson & Johnson has been the defendant in many cases, and has opted for confidential settlements in the past.
If you have been harmed by a morcellator in any way, including the spread of cancerous tumors, contact Kaiser Gornick, LLP today. Our San Francisco defective medical product attorneys can take on cases for clients from the west coast clear to the east. With more than 60 years of combined experience taking on some of the biggest oppositions in medical device cases, we have been able to land multimillion dollar case results for our clients. Set up your free initial consultation today to learn more.