A recent FDA safety communication means fewer options for women having a hysterectomy. In spite of recent efforts by doctors to create a safer environment for morcellation, hospitals are developing strict guidelines restricting the use of morcellation, in and out of sack, following the FDA's safety communication.
"This is a step backward for women's health," explained Kathy Kelley, founder and CEO of www.HysterSisters.com. "Hopefully this decision can be revised as doctors demonstrate the ability to offer minimally invasive surgery options with the safety of a protective sack when morcellation is needed. We certainly do not want to go back to the days of a large abdominal incision being our only surgery option."
Benefits of the use of morcellation
Morcellation means cutting an object or tissue into smaller pieces for removal. When it comes to gynecology, it could mean cutting up the uterus, polyps, tumors, or fibroids so they can be removed through a smaller opening. Morcellation gives women who have an enlarged uterus or a large fibroid the option of minimally invasive surgery (MIS), meaning smaller incisions, fewer surgical risks, and shorter healing time. Otherwise, their only option is a large abdominal incision. Morcellation also gives women who wish to keep their cervix the option of MIS. Eliminating morcellation, therefore, could negatively affect a significant number of women seeking MIS and/or a supracervical hysterectomy.
The risk of using morcellation
Based on one woman’s unfortunate recent experience, there has been a lot of concern in the media about the possibility of spreading undiagnosed cancer, specifically uterine leiomyosarcoma (ULMS), during minimally invasive surgery (MIS) with morcellation. This has led to a national campaign, rallying support with the FDA. The FDA has reported that this type of cancer occurs in 1 out of 350 women, but the American Congress of Obstetricians and Gynecologists (ACOG) and the American Cancer Society report a much smaller statistic of about 1 in 1,000. HysterSisters’ member surveys support this smaller percentage.
Upcoming surgeries changed from MIS to open incisions
Dr. Antonio Gargiulo, director of robotic surgery at Brigham and Women's Hospital in Boston explained, "In our hospital alone, as many as 600 women this year may have to undergo open surgery instead of the laparoscopic surgery the same number of women underwent last year. This will mean countless more cases of pelvic and wound infections, deep venous thrombosis, urinary tract injuries, and other nosocomial infections. It will also mean that these women will have to take on an average of three extra weeks of time off from work, with the cost to society and lack of income that comes with that. Many women will likely decide to defer their surgery due to fear of the above, and may end up with more advanced disease and more complex surgeries in the future."
Hospitals making strict policies against morcellation use
Following the FDA safety communication, some hospitals have taken the guidelines and implemented strict policies against morcellation, even with safety procedures in place.
As Gargiulo explains, "Over the past few months, our department had successfully implemented safe morcellation techniques employing virtually indestructible specimen bags made of parachute-grade material. This had been the new standard at Brigham and Women's Hospital for weeks, and we were posed to teach it to the rest of the medical community so that open power morcellation could come to an end while still giving women the option of a minimally invasive approach. This unexpected veto came down on us from our administration following the FDA communication, no questions asked."
HysterSisters encourages all women to discuss options with their surgeon, getting a second and third opinion to gain better understanding and perspective to make the best decisions for the best patient outcomes.
"We hope that the FDA will revise their decision to include the use of morcellation in protective sacks, based on the decision of the patient and surgeon in full disclosure of the risks involved," Kelley explains. "We cannot go back to our mother's hysterectomies because of fear; we need to move forward with the knowledge available to us in the 21st century. Women deserve to have safe, minimally invasive surgery options."
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