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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

The FDA has warned that approximately 1 in 350 women who are undergoing laparoscopic uterine surgery for benign fibroids in fact have an unsuspected type of cancer known as a uterine sarcoma. The use of laparoscopic power morcellation increases the risk that cancerous tissue within the uterus will be spread throughout the patient's abdomen and pelvis, decreasing the patient's chances of survival.

When the FDA issued its warning, it noted that women undergoing hysterectomy or myomectomy for uterine fibroids should not have surgery that involves the use of a power morcellator. There is currently no way to determine prior to surgery whether a patient's fibroids are in fact cancerous. Meanwhile, there are other surgeries to perform successful hysterectomy or myomectomy for fibroids that do not share a risk of spreading cancer, though they may have longer recovery times.

Manufacturers of power morcellators have been requested by the FDA to update their warning to include two contraindications and a boxed warning on the product label.

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.

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LAPAROSCOPIC POWER MORCELLATION LEGAL ARTICLES AND INTERVIEWS

Damning Report on FDA Approval of Power Morcellators Released
Damning Report on FDA Approval of Power Morcellators Released Washington, DC: According to findings from a just-released investigative report, during the past 20 years the US Food and Drug Administration (FDA) has approved 25 surgical devices such as power morcellators, that have the potential to spread undiagnosed cervical cancer in women [READ MORE]

Power Morcellator Patient Advocate Dies
Power Morcellator Patient Advocate Dies Pittsburgh, PA Bonnie Davis, a patient who fought to ensure patients knew about the risks associated with power morcellation has died at age 57 from cancer. Davis had undergone power morcellation in 2012 and was diagnosed six days later with cancer. She worked to raise awareness of the serious risks reportedly linked to the use of power morcellators, to prevent other women from going through what she went through [READ MORE]

Olympus America Attempts a Power Morcellation Comeback
Olympus America Attempts a Power Morcellation Comeback Orlando, FL: In spite of a position taken by the US Food and Drug Administration (FDA) that Laparoscopic Uterine Surgery for women Involving power morcellators only be used in relatively rare cases, Olympus America Inc. has released a new power morcellator equipped with a containment bag [READ MORE]



READER COMMENTS

Posted by
Britt Moise
on
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
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.

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