Power Morcellators Pulled From Global Markets

Power Morcellators Pulled From Global Markets | Pintas & Mullins Law Firm

Three companies recently recalled their power morcellator devices due to recent national outcry over their safety. These devices, used in hysterectomies and other gynecological procedures, are now connected to a serious risk of uterine and abdominal cancer. The team of uterine cancer attorneys at Pintas & Mullins Law Firm urges all women recently diagnosed with abdominal cancer to seek legal advice as soon as possible.

Power morcellators are used in thousands of minimally-invasive procedures every year, most often to remove growths known as uterine fibroids. According to the Mayo Clinic, uterine fibroids are noncancerous growths inside the uterus that most women will develop at some point in their lives. The growth patterns of these fibroids vary from person to person – in some women they grow rapidly and spread throughout the uterus, causing severe complications. In others, the fibroids grow and shrink on their own without causing any symptoms at all.

In more severe cases, uterine fibroids can cause infertility, major blood loss, pelvic pain, and even miscarriages. For these patients, doctors often recommend removing fibroids before trying to conceive. Although there are many ways to remove or treat fibroids – no single best treatment is identified as ‘best’ – many doctors suggest using power morcellators to shave down fibroids into small pieces, so they may be removed through a tiny incision.

This is among the most minimally-invasive modes of removal, which is why so many women have chosen this form of treatment. In the past, the procedure was recommended because patients would benefit from shorter hospital stays, fewer complications, and smaller scars than other alternatives.

Studies published in 2012 revealed that these power morcellation procedures were causing devastating illness in women throughout the country. We recently wrote a post on the two doctors, a husband and wife, who brought this issue to national attention. Dr. Amy Reed was diagnosed with advanced-stage cancer after undergoing a hysterectomy using a power morcellator.

Senators Urge FDA to Recall All Morcellators

In August 2014, two U.S. senators asked the FDA to remove all power morcellator devices from the market. The two senators wrote a joint letter to the federal agency, citing recent studies from Bringham and Women’s Hospital in Boston, which found that the actual risk of cancer spread is nine times greater than patients are currently told. This is unacceptable.

This is the same study that caused Johnson & Johnson to recall three models of power morcellators from hospitals worldwide. For its part, the FDA has urged all doctors to stop using power morcellators in gynecologic procedures, however, it has stopped short of issuing a total ban.

Power morcellators are also used in spleen and renal surgeries, although they have not been associated in cancers in these organs. A spokesperson for J&J recently told reportersthat the risks and benefits of these devices remain unknown, and the decision to remove them from global markets was prompted by an FDA meeting in July 2014.

In this meeting, the FDA detailed the risks associated with the device and problems within the medical community. The most pressing problem is that, although women who undergo procedures to remove uterine fibroids are screened for several forms of cancer, the most aggressive forms are undetectable. Among the most serious cancer types that can spread from power morcellator use is metastatic leiomysarcoma, which occurs primarily in women aged 40 to 60.

The FDA issued a safety report on this type of cancer specifically in April 2014, alerting doctors to the possibility of cancer spread an discouraging the use of power morcellators. The good news is that there are many ways to remove uterine fibroids without using a device like a power morcellator. Surgeons can go in manually with a scalpel or scissors, which is more invasive but considerably safer. 

Uterine cancer is the fourth most common cancer among women; those at highest risk are women with high levels of estrogen, being over the age of 40, family history of cancer, and being obese. Some drugs are known to increase uterine cancer risk, including hormone replacement therapy and some drugs used to treat breast cancer.

If you or someone close to you underwent a uterine procedure using a power morcellator and was consequently diagnosed with cancer, contact our firm immediately. You and your family do have legal options, however, there is a limited amount of time to act on them. Contact us today with any questions regarding uterine fibroids and power morcellators. Our team of power morcellator attorneys provides free legal consultations and takes on clients from all 50 states.