Laparoscopic Power Morcellator

Study Supports FDA Warning About Power Morcellator
The power morcellator, a surgical device used to mince large masses of tissue inside the body so the material can be extracted through small incisions, has been the center of debate since the Food and Drug Administration discouraged its use in April.

A study by doctors at Columbia University, published in the Journal of the American Medical Association, found that nearly 1 in 370 women who undergo a hysterectomy and use a morcellator have been found to have previously undetected uterine cancers.  The study involved 232,882 cases in which women at 500 hospitals underwent minimally invasive hysterectomies using various approaches, including 36,470 women who had power morcellation.

Doctors who support the continued use of morcellators have argued that the risk of hidden cancer is low for younger women and that morcellation remains a safe option.  But Jason D. Wright, lead author of the study and chief of the gynecologic oncology division at the Columbia University College of Physicians and Surgeons and his colleagues found that 32 percent of the morcellation patients found to have undetected uterine cancer were younger than 50.

The study urged doctors to fully communicate the risk to their patients before surgery.
Most women will develop uterine fibroids at some point in their lives.  Fibroids are common, and affect half or more women during their reproductive years.  Most women with fibroids are unaware they have them, but other women can experience symptoms such as anemia, backaches, bleeding between periods, constipation, frequent urination, pelvic pressure and prolonged heavy periods.  They can sometimes cause infertility or miscarriage.

Laparoscopic power morcellation is one of several available treatments for fibroids. It is a procedure that uses a medical device to divide the uterine tissue into smaller pieces or fragments so it can be removed through a small incision in the abdomen.

The U.S. Food and Drug Administration discouraged the use of laparoscopic power morcellation for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy) in women because, based on an analysis of currently available data, it poses a risk of spreading unsuspected cancerous tissue.

Fibroids are typically detected through a pelvic exam, such as a sonogram or M.R.I.

A number of additional treatment options are available for women with symptomatic uterine fibroids, including traditional surgical hysterectomy and myomectomy, and laparoscopic hysterectomy and myomectomy without morcellation, as well as other non-surgical options.

Noninvasive ultrasound surgery can be used to heat and destroy a fibroid without damaging the uterus. A fibroid also can be destroyed by injecting small particles into uterine arteries to cut off its blood supply.

If you are considering treatment for fibroids, your doctor should answer several important questions, like:

•  What is the nature of the problem?
•  How necessary is it to treat it?
•  What procedures are known to be effective?
•  What are the risks and benefits of each procedure?
•  What is the approach you recommend?
•  How much experience do you have with the approach you recommend?
•  What are its possible complications?
•  How often do the complications occur?

In fact, any time your doctor recommends any kind of treatment, especially invasive surgery, these are good questions to ask. The decisions that you make with your doctor's answers may save your life.

J&J Takes Morcellator Off the Market Due to Cancer Threat
It is not exactly a recall - but Johnson and Johnson (J&J) has removed from the market its Laparoscopic Power Morcellation, a medical device used to break uterine fibroids into little pieces using a cylindrical blade with a tube to extract the tissue. The problem is in removing a uterine fibroid, one cannot be certain if it is a cancerous tumor. Decimating it into little pieces can spread undetected uterine cancer. The Food and Drug Administration (FDA) did not issue a recall but J&J announced it would suspend global sales after the FDA issued a safety bulletin April 17th.

The story came to light with the case of Amy Reed. The physician and mother of six had a fibroid removed during a hysterectomy and soon developed stage four aggressive uterine cancer known as leiomyosarcoma. She is undergoing six rounds of chemotherapy to fight the cancer.

One in 350 fibroids carry the potential for uterine sarcoma, according to the FDA, and women are generally unaware they have the cancer. According to the American Cancer Society there will be 1,600 cases of uterine sarcoma identified in the U.S. this year.

Alternatives to a power morcellation myomectomy include using a scalpel to remove the fibroids and then contain them in an isolation bag. Abdominal surgery, another traditional mode of hysterectomy, carries an increased risk of injury.

While the latest and greatest “minimally invasive” power tools often impress doctors who hope to impress their patients, hospitals such as Brigham and Women’s Hospital, which operated on Amy Reed, have been begun to restrict use of power morcellation, which is used in just above 10 percent of the 600,000 hysterectomies performed annually in the U.S., according to the American Congress of Obstetricians and Gynecologists (ACOG).

ACOG in a position paper says it is difficult to calculate the risk of morcellating an undiagnosed cancer.

The power morcellation medical device is just another example of a device approved under the FDA’s lax 510(k) approval process that involves a few thousand dollars and an exchange of paperwork. “No clinical trials are performed” says the application. That is how we are finding out too often that the patient population of the U.S. becomes the unsuspecting enrollees of an undeclared and unmonitored clinical trial.

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