Surgeons Continue to Use Power Morcellators Despite FDA Warnings

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Have you had a hysterectomy or myomectomy? Did your surgeon perform the procedure using a laparoscopic power morcellator? That surgical tool has raised serious concerns and may soon be banned by the Food and Drug Administration. If you had gynecological surgery, you should inquire whether a power morcellator was used during the procedure. If you anticipate undergoing gynecological surgery, you should ask your surgeon whether he or she intends to use a power morcellator.

What is a power morcellator?

Surgeons use a laparoscopic power morcellator to break tissue into fragments that can be removed through a small incision in the abdomen. It has most often been used to perform hysterectomies (removal of the uteris) and myomectomies (removal of uterine fibroids). Advocates of the device argue that it makes surgery less invasive and that surgical patients benefit from minimal scarring. Use of the power morcellator has become widespread for those reasons.

What are the potential risks of morcellation?

According to the FDA, power morcellation has been linked to the spread of previously undetected cancers. After analyzing available data, the FDA concluded that 1 of 350 women who undergo a hysterectomy or myomectomy have unsuspected uterine cancer. If power morcellation causes those cancers to spread, the affected women face shorter lifespans and painful deaths.

The risks of power morcellation are higher for older patients who are more likely to have hidden cancers and for patients with a history of uterine cancer. The risk may outweigh the benefit for any patient, particularly those who seek removal of a fibrous growth that causes no pressing health concern.

What has the FDA done?

While the FDA has not yet restricted use of the power morcellator, it has discouraged surgeons from employing the device. Actions the FDA may take include limiting use of the product to specific surgeries, requiring a warning to be included with the device, mandating written disclosure of risks to patients, or banning the device outright.

What has the manufacturer done?

The company that makes power morcellators, a division of Johnson & Johnson, announced in April that it would stop selling the device. While it initially labeled that suspension of sales as “temporary,” the company announced in late July that it would recall the devices.

What do doctors think?

Doctors are divided as to whether use of the morcellator should be outlawed. Some surgeons believe that the 1 in 350 statistic indicates that morcellation is a safe procedure for the large majority of women. Some intend to continue using power morcellators despite the product recall.

Other doctors, including some who believe their own cancers were spread by morcellation, contend that the risk is too significant to overlook. Since there is no reliable way to determine whether a uterine fibroid is cancerous before it is removed, those doctors are urging the FDA to ban the procedure in all instances.

How can you protect yourself?

Uterine fibroids are noncancerous growths in the tissue of the uterus. Most women develop uterine fibroids at some point. Uterine fibroids do not cause a problem for most women, but they can cause heavier menstrual bleeding, pelvic pain, and frequent urination. It is always wise to consider non-surgical treatments first and to view surgical removal of the fibroids as a last resort.

For women who choose to have a hysterectomy or myomectomy but do not want to take the risk of power morcellation, alternative surgical techniques are available. They include traditional vaginal and abdominal hysterectomies and myomectomies and laparoscopic procedures that do not employ a power morcellator. If you have a history of uterine cancer or if cancer is suspected, the FDA strongly recommends that you avoid surgery that involves morcellation.

You should discuss the risks and benefits of different procedures with your physician. If you surgeon recommends using a power morcellator, ask why the surgeon intends to disregard the product recall and the FDA’s advice. If the surgeon insists that morcellation is safe, get a second opinion from a doctor who is not affiliated with the surgeon you originally planned to use. While the choice is ultimately yours, you should make a fully informed decision.

What should you do if a power morcellator was used during your surgery?

Tissues that are removed during a hysterectomy or myomectomy are often tested for the presence of cancer. If that was not done in your case, ask for the test to be performed. If the test may have been done but you were not notified of the result, ask your doctor to send you a copy of the lab report.

If you are the unfortunate victim of a spreading cancer caused by morcellation, you should consider seeking compensation for your pain and suffering and for the likelihood that your life has been shortened by the procedure. A personal injury attorney who has experience with medical malpractice and/or products liability can evaluate your case and help you receive the justice that you deserve.

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