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Since the 1990s, morcellators have been used in over 50,000 fibroid-removal
procedures and hysterectomies each year, and have helped countless gynecologists
perform these procedures with minimal scaring and reduced recovery time.
The instrument, known as a power morcellator, uses a tube-shaped blade
to remove fibroids from the uterus-or in some cases, the entire uterus.
Unfortunately for many women, this procedure also increases the risk of
spreading an undetectable form of cancer known as uterine sarcoma.
Golomb & Honik, P.C. is currently investigating Morcellator cancer claims.
Request a free
case evaluation today.
What are Fibroids?
Symptomatic fibroids are the reason for about 40% of the 500,000 hysterectomies
that are performed every year in the United States. Women who are suffering
from fibroids can experience heavy bleeding, pelvic pain, and discomfort.
It is estimated that 20-40% of women age 35 and older have uterine fibroids
of a significant size.
One of the main ways to treat symptomatic fibroids is to remove them completely
or perform a total hysterectomy. For the last several decades, a growing
number of gynecologists used the morcellator to perform these procedures
without having to subject patients to traditional, open surgery.
Morcellator & Uterine Cancer
In April 2014, the Food and Drug Administration advised doctors to stop
using the morcellator to perform hysterectomies or fibroid removal on
women, citing its potential to spread a deadly uterine cancer. It is estimated
that one in 350 women undergoing these procedures actually has a undetectable
cancer known as uterine sarcoma. When the morcellator is used, it can
significantly worsen the cancer, and the odds of long-term survival.
Physicians are concerned that using this powerful device to cut into cancerous
tissue raises the risk of those malignant cells spreading to other tissues
and advancing to a more dangerous and life-threatening stage. Unfortunately,
uterine sarcomas cannot be detected until they are removed-and they are
often mistaken for fibroids.
The FDA urges physicians and other doctors to avoid using the morcellator
and turn to traditional open surgeries, other forms of minimally invasive
surgeries, and nonsurgical alternatives to treat fibroids. Some of these
treatments can include vaginal hysterectomies, drug therapy, and even
ultrasound treatment.
Manufacturers of Morcellators
One of the largest makers of power morcellators is Johnson & Johnson’s
Ethicon subsidiary. The company said that it will review the product labeling,
per the FDA’s request and plans for an advisory committee meeting
regarding the discouraging news. At the end of April 2014, Johnson &
Johnson suspended worldwide sales, distribution, and promotion of its
laparoscopic power morcellators. Those devices that were suspended include:
- Gynecare Morcellex Tissue Morcellator
- Morcellex Sigma Tissue Morcellator System
- Gynecare X-Tract Tissue Morcellator
Safety critics are calling for Johnson & Johnson to recall these products,
not merely suspend the sales of them. Until these devices are pulled from
the market, they are still a danger to be used on unsuspecting women,
raising their risk of deadly cancer.
Medical Needs & Legal Help
Women who have already had hysterectomies or myomectomies (removal of fibroid
tissue) are urged to consult with their physician and attend a routine
follow-up. If you have persistent or recurrent symptoms, or if your post-surgery
tests come back positive for cancer, it is important to seek medical care
immediately, as your cancer could have worsened from morcellator use.
If you or someone you love has been diagnosed with uterine cancer or medical
complications after fibroid removal, you may have cause to file a claim
against the manufacturer of the morcellator device. It is imperative that
you discuss your case with an experienced and skilled Philadelphia product
liability attorney immediately.
National Defective Medical Device Lawyers
If you or someone you love has suffered health complications or if your
cancer has spread aggressively after your physician used a morcellator
during your hysterectomy, you may be able to file a lawsuit. Women who
have been diagnosed with uterine sarcoma after undergoing a hysterectomy
may be able to file a lawsuit against the product’s manufacturer.
We would be happy to review your case for free. Fill out a complimentary
case evaluation form to get started. To
contact us immediately, call (215) 278-4449.