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Surgical device actually spreads cancer instead of removing it. Learn why gynecologists are being told not to use this during surgery.

Up until now hysterectomies have been performed using a device that has been shown to be unsafe for the health of patients in recent reports. Despite new data showing that the device spreads cancer, some doctors continue to use it. But now even a manufacturer of these types of devices is speaking out for physicians to discontinue use of it.

Time magazine reports on the new method to be used for hysterectomies. 

Many gyn surgeons performing hysterectomies use a device created by Johnson & Johnson. But now even J&J is urging doctors to discontinue using it for fear of spreading cancer through its' use. The device is called a 'morcellator'. The company made its official announcement on Wednesday and is said to be issuing more statements soon.

These devices, which have been used in hysterectomy surgery for years, are said to spread uterine cancer. They also lower the potential chances of survival after the cancer is caught. The Food and Drug Administration first issued a warning against using the device a few months ago. However, some surgeons decided to continue with their normal use of the tool. Now reports show the device almost definitely spreads cancer.

“Sales of the company’s laparoscopic power morcellators, used during hysterectomies and fibroid-removal surgery, were halted in April. The FDA told members of the medical community that the device could spread a form of uterine cancer called sarcoma in patients, lowering chances of survival,” according to Time.  

Johnson and Johnson has gone as far as urging those of the medical community who have purchased the device to return it or at least discontinue use of it. They find that any advantage of the device in using it for the surgery is not greater than the disadvantage caused by using it, which is the spread of cancer in many cases. The company originally defended the device when the FDA’s report first came out; but now they have changed course and are urging the discontinuation of it.

Time reports, “Two recent studies — from the FDA and researchers at Columbia University - found that around 1 in 350 women has undetected cancer when being treated for fibroids; for women having hysterectomies, the risk is around 1 in 368.” But apparently the risk is even greater than these statistics.

Fox news also reported on the dangers the device holds to patients.

Johnson & Johnson was actually the biggest manufacturer of the device, with J&J pulling out; experts hope that all surgeons will finally discontinue using it.

“The company plans to tell customers world-wide in a letter Thursday to return the devices known as 'laparoscopic power morcellators'. J&J already suspended sales of new morcellators in April after the U.S. Food and Drug Administration advised doctors not to use the tool, which slices up common uterine masses called fibroids, and uteruses themselves, into fragments so they can be removed in minimally invasive surgery,” according to Fox.

When a doctor attempts to remove day a object from the uterus, it is often impossible to remove it using a tiny hole made during laparoscopic surgery. This morcellator literally would cut up the object be removed into little pieces, allowing the gynecologist to remove it in a bag small enough to take out of the laparoscopic port hole.

J&J changed their stance after viewing statistics and reports offered by the FDA at a hearing earlier this month. The FDA presented evidence showing that the link between the devices and uterine cancer was undeniable.

How dangerous is uterine cancer?

It is difficult to detect uterine cancer, which is why it often goes unnoticed until later stages. This delay in detection makes it more difficult to treat. The most common type of uterine cancer is type 1 endometrial cancer. This consists of the growth of abnormal cells in the lining of the uterus. The lining is called the endometrium. It generally occurs in women over the age of fifty. It is usually diagnosed with a biopsy.

Fox reports, “Uterine cancers called sarcomas can masquerade as benign fibroids and can't be reliably detected before surgery. Using a morcellator can inadvertently spread malignancies and other diseased tissues inside the body, possible worsening outcomes.”

What is the main treatment for uterine cancer?

It is usually surgery to remove the uterus plus cervix, ovaries, and fallopian tubes. Other treatments include radiation therapy, hormone therapy and chemotherapy. Another form of uterine cancer is sarcoma, which is cancer of the muscle in the uterus. These are rare because they occur in a different type of tissue. They grow in connective tissue, which are cells that connect other kinds of tissue in your body. These can develop anywhere in the body and are generally seen as a lump that starts off painless but gets bigger and bigger. Usually they are detected through a biopsy, CT scan, ultrasound, MRI, or bone scan. The way it is treated depends on which part of the body it is in and how big it is.

Dr. McCarus, an expert on the morcellator who previously used it as a chief of gynecological surgery at a Florida hospital issued a statement saying, “The bottom line is that it looks like the sarcoma risk is much higher than we originally thought.” He emphasized the importance of discontinuing use of the device.

Experts are urging patients to be their own best advocates by double checking prior to surgery to make sure that their doctor will not be using a morcellator. Going forward, most gynecologic surgeons will most likely not be utilizing the device after the guidelines and new information that has been disclosed by the Food and Drug Administration.

 


Gerry Oginski
NY Medical Malpractice & Personal Injury Trial Lawyer