FDA Warns Against Laparoscopic Power Morcellation

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The US Food and Drug Administration (FDA) has issued a safety communication warning against the use of laparoscopic power morcellation for laparoscopic uterine surgery, including hysterectomy or myomectomy (uterine fibroid removal). Of concern are reports of the spread of unsuspected cancerous tissue specifically, uterine sarcoma during laparoscopic hysterectomy. Laparoscopic power morcellation lawsuits have now been filed by women alleging they were harmed by the use of a power morcellator during laparoscopic hysterectomy.

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Laparoscopic Power Morcellation

Laparoscopic uterine surgery via power morcellator has been marketed as a non-invasive hysterectomy or myomectomy. The surgery is used in women who are undergoing a hysterectomy or myomectomy for uterine fibroids. Power morcellation is a procedure that uses a medical device to break the uterine tissue into smaller pieces so it can be removed through a small incision in the patient's abdomen. Uterine fibroids are typically non-cancerous growths in the uterus that do not generally cause health problems but can cause pelvic pressure, pain and prolonged menstrual bleeding.

Power Morcellation has been used as a replacement for traditional surgery because the smaller incision puts the patient at less risk of blood loss and infection and generally has a shorter recovery time.

FDA Power Morcellation Warning

In 2014 the FDA issued a safety communication on power morcellators and recommended that manufacturers add a boxed warning to device labels. The agency also warned that the "vast majority" of women undergoing removal of the uterus (hysterectomy) or fibroids (myomectomy) should not have surgery that involves the use of a power morcellator.

However, a Feb. 2017 report issued by the US Government Accountability Office (GAO) revealed that the FDA already knew of the potential risk for laparoscopic power morcellators to spread cancer 22 years before issuing its 2014 warning.

According the GAO report, the FDA "was aware of the potential for power morcellators to spread tissue (cancerous and noncancerous) when the agency cleared the first device in 1991" but believed there was a low risk of unsuspected cancers that could spread.

Power Morcellation Devices:

Ethicon Gynecare Morcellex Tissue Morcellator
Morcellex Sigma Tissue Morcellator System
Gynecare X-Tract Tissue Morcellator

In July 2014, Johnson & Johnson sent a letter to medical care providers as part of that company's worldwide voluntary market withdrawal of all Ethicon Morcellation Devices. In its letter, Johnson & Johnson noted, "the risk-benefit assessment associated with the use of these devices in hysterectomy and myomectomy procedures for removing fibroids remains uncertain."

Power Morcellation Lawsuits

Lawsuits have now been filed against the makers of some power morcellation devices, alleging women were harmed by the use of the devices. The lawsuits allege the use of a morcellator device resulted in an aggressive cancer—leiomyosarcoma—spreading throughout the patient's body. The lawsuit alleges that Ethicon—a division of Johnson & Johnson—knew or should have known about the risk of a morcellation device spreading cancer in the patient's body, but failed to warn about that risk.

Power Morcellation Legal Help

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Last updated on Feb-27-17

LAPAROSCOPIC POWER MORCELLATION LEGAL ARTICLES AND INTERVIEWS

Don't Use Ultrasonic Aspirators to Remove Uterine Fibroids FDA States

October 31, 2017

Washington, DC: The US Food and Drug Administration (FDA) has provided the medical community with guidance on the use of ultrasonic surgical aspirators. Specifically, the agency is advising companies that make the devices to label them as contraindicated for the removal of uterine fibroids. The non-binding guidance from the agency serves to strengthen its recent warnings about the use of power morcellators to remove uterine fibroids. READ MORE

Power Morcellation Cancer Warning One Year Too Late for Doctor

July 10, 2017

:Washington, DC: Dr. Amy Reed, a physician and mother of six had surgery for uterine fibroids with a power morcelletor one year before the FDA first warned about the risk of power morcellators spreading cancer. Dr. Reed died from cancer in May—she was 44 years old.

The power morcellator had scattered malignant cancer cells inside Dr. Reed’s abdomen during surgery, which left her with advanced, Stage 4 cancer. After her surgery, a biopsy found that she had leiomyosarcoma, an aggressive type of cancer, and only then was she and her husband, surgeon Dr. Noorchashm told that a power morcellator was used to slice up her uterus, reported the New York Times (May 24, 2017).

Horrifically ironic, Dr. Reed and Dr. Noorchashm advocated against the power morcellation procedure for four years, which led to the FDA warning in 2014 against the use of laparoscopic morcellators to treat uterine fibroids. One year later, the agency was looking into whether on not Johnson & Johnson – the largest manufacturer of the device—knew about the risk of spreading cancer before pulling its power morcellator off the market. But other manufacturers did not follow suit. The power morcellator is a big seller for several medical device companies: according to the FDA, at least 50,000 women in the US undergo a hysterectomy — removal of the uterus—every year.

Incredibly, the power morcellator was approved by the FDA’s 501(k) fast -track process, meaning it didn’t undergo any human clinical trials, despite that agency estimating that 1 in 350 U.S. women who undergo fibroid procedures each year have a form of cancer called uterine sarcoma.

After going public about the power morcellator’s hazards and calling for a complete ban of the device, Dr. Reed and her husband were ostracized both by the hospital where she had the surgery and many gynecologists who favored the device. According to The Times, when Dr. Reed returned to Brigham and Women’s for a medical procedure, she and Dr. Noorchashm “were stunned to find that the hospital had assigned a guard to inspect their bags and escort them at all times, for security reasons. Dr. Noorchashm called a lawyer. A judge put a stop to the escort, issuing a restraining order against the hospital.”

This action by the hospital and the gynecology profession begs the question: are they receiving perks from power morcellation manufacturers? It wouldn’t be the first time that doctors were bribed by drug companies to increase sales, and even sit on their advisory committees…
READ MORE

Olympus Settles Four Power Morcellator Lawsuits

June 18, 2017

Upper Saucon Township, PA: Olympus Corp. of the Americas has settled four lawsuits for injuries and one death allegedly related to the company's power morcellator surgical device, according to The Morning Call. READ MORE

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READER COMMENTS

Posted by
Zineta Osmanovic
on November 6, 2017

Hi I have a question I had my hysterectomy done on February 2nd of 2017 I was diagnosed with a fibroid of 12 weeks pregnancy and cervical cells for cancer when I find it when I was really scared I didn't know what to do but also I wanted to have kids because that's the reason I came in office to ask for help and when I find out I have all that I ask my doctor also about can he help me with my fibroid can he clean and me to stay pregnant again because I wanted the kids and all he gave me is he said that I can't have no more kids and he can do nothing about it that is no chance my husband was with me when he said that so I'm not sure now since this hysterectomy is done I regret I have a lot of changes complications and he never mentioned me going to see another doctor or a command it before I made my decision and I didn't know anything about it I trusted the doctor now that I find out that is a chance of that some woman having fibroid removed and have kids again now I lost all of it and I have a lot of changes which is not normal I wish I never done this I need some somebody's help now that I find out that everybody else is having a baby and they're in the same position that I was I don't know what to do can you guys help me out because I think this is a big mistake

Posted by
Celeste
on June 2, 2017

I had a hysterectomy where it left me incontinence where a second surgery will be needed.

Posted by
Elisabeth Durant
on March 10, 2017

I had the surgery in 2013, I noticed I use the bathroom a lot and have some stomach problems.

Posted by
Britt Moise
on May 27, 2016

My name is Britt Moise and I am here to tell you to never undergo surgery for a myomectomy or hysterectomy. The firdt sugery is for removing fibroid tumors the second is to remove your uterus. My first surgery was laparoscopy when I was 18 years old. I was a beautiful girl who had modeled in NY NY. With Elite agency. I needed a gynecologist because I was having some mild pain during I sex and after orgasm. A friend suggested their dr. In Beverly Hill's who happened to be an infertility specialist. I went in and he immediately had me in surgery that was for exploratory reasons he said. I have no doubt he used it as an excuse to take my eggs for his fertility clinic. I was young and alone in LA and at 18 in 1983 had not even thought to have questioned his suggestions. He said I had endometriosis and should be on birth control the rest of my life. OK? I did but never felt It was a true statement. It did not help my pain that eventually went away being a vitamin deficiency, I later learned . Later I learned I never had endometriosis. I learned from. Another eager beaver Dr. Who decided to cure my heavy periods with a Morcelator. Thank you Dr! How kind of you to cut up my tiny fibroid a d a bunch of my uterus with it. Picture the uterus and make me sick a week for the rest of my life. Tons of blood and tissue left me with transfusions and a horrific inability to lead life as I normally had. No option but to take my uterus in order to stop hemorrhaging. No child would I ever have. My life felt empty and no one understood. No one wants to talk a out blood and your period. If it was my arm that was bleeding uncontrollably it would be fine, but not my uterus. OK for the third Gynecologist, I once again went to surgery. Take this Morcellator seeded uterus out in order to live. She used a Morcellator on me even after during me from side to side and sliced my bladder in two. Thank you Dr.! I now urinate uncontrollably. How can the FDA not be the one being prosecuted here? Dr where is your area of speciality. Is is in an office keeping women healthy and checking there vagina's? Or are you a surgeon? You can't be both? Unfortunately in this country you can. You can also patent a tool used on millions of women giving them cancer and not even have to test it first . Years of Morcellation with electro cautery and no real training required. Please someone question and persue this sad organization we call the FDA and the medical board. How could you allow us women to die and be mutilated by your negligence and complete denial?

Posted by
Anonymous
on February 17, 2015

A simple procedure to remove one single fibroid tumor was the day my life ended as I once knew it. on and after the surgery 4 days I bled and bled. I had chunks of tissue I had to bear down and push out of me my vagina. I would bleed so much blood I didn't know I could still be standing.
Super tampons and pads would not be efficient. Adult diapers along with towels padded underneath them were the only thing that would control the bleeding. Sudden gushes of blood would unpredictably happen on a weekly basis. I no longer could stand and do my job which was a successful well-paid high end hairstylist. One month from surgery I had an ultrasound that showed 2 fibroid tumors. I didn't know what was happening the surgeon just told me a hysterectomy would solve the problem. The problem was I wanted children I went in for a simple procedure with no chance of ending in a hysterectomy. I wanted a life like everybody else I wanted to get married I wanted to have a family. I wanted my life back so bad but it ended and changed forever. I went on trying to wait till something came out maybe something new surgery some type of hope so that I could have a family. The bleeding got worse the tissue continued to come out of my vagina and it got more painful. Finally I lost everything and lived in my car. I was so weak I could hardly stand I had to sit in the shower I couldn't lift a small box even. I didn't really have air in my lungs from the lack of blood in my body. By the time I finally gave in to any chance of ever having a family and had a hysterectomy a fibroid mass the size of a large melon was removed from my uterus. At least 5 large lemon size fibroid tumors that the mor morcelator had caused. The tool had spun the seeds that are inside fibroids around my uterus. The fibroid seeds are lime wart seeds and spreed. The tool had planted the seeds like a well for garden. The fibroids grew they were so well seeded. Life was never the same and is much different today then before that day of surgery. No woman should have to go through this. I was born with the ability to have a child family and that was taken from me in a few moments with a tool that should have never been made.