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 responds
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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Add a Comment7 Comments
No Hysterectomies is the answer. Hysterectomy leads to pelvic organ prolapse, incontinence, etc. Then they implant synthetic srugcial mesh. Then they remove the mesh. Hysterectomy opens the profit door for doctors destroying the woman surgery, after surgery, after surgery. The entire female reproductive system needs to remain intact. J&J wants to be able to sell its morcellator again and you are helping them, Kathy Kelley, as you have for years. Still have those lucrative contracts with industry while you feed women to morcellator misery and risk of cancer?
June 14, 2015 - 8:44pmThis Comment
The banning of the morcellator does not go a long way toward stopping the gross overuse and harm caused by hysterectomy but at least it is a start. According to this 2000 study http://www.ncbi.nlm.nih.gov/pubmed/10674580, 70% of hysterectomies were inappropriately recommended and 76% did not meet ACOG criteria. Equally troubling is that 78% of women aged 45 to 64 lose healthy ovaries (the equivalent of a man's testicles) at the time of hysterectomy despite the average woman's lifetime risk of ovarian cancer being a measly 1.4%.
http://www.ncbi.nlm.nih.gov/pubmed/10674580
http://www.ncbi.nlm.nih.gov/pubmed/19702455
The ovaries of a woman with all her parts produce hormones into her 70's especially androgens that can convert into estrogen as needed by the body. Total testosterone levels increase in INTACT aging women reaching premenopausal levels in ages 70-79. These hormones are essential for many aspects of health. Hysterectomized and oophorectomized women have lower levels of hormones increasing their health risks.
- http://journals.lww.com/greenjournal/Fulltext/2005/08000/Ovarian_Conservation_at_the_Time_of_Hysterectomy.4.aspx
- http://press.endocrine.org/doi/full/10.1210/jcem.85.2.6405
Clearly, hysterectomy and/or oophorectomy can do more harm than good.
June 10, 2015 - 2:41pmThis Comment
http://www.lexisnexis.com/legalnewsroom/litigation/b/litigation-blog/archive/2014/04/09/da-vinci-surgical-robot-maker-reserves-67m-to-settle-product-liability-claims.aspx
04-09-2014 | 03:07 PM
Author: Tom Moylan
Da Vinci Surgical Robot Maker Reserves $67M To Settle Product Liability Claims
SUNNYVALE, Calif. — (Mealey's) Intuitive Surgical Inc. on April 8 announced that it has taken a $67 million charge against 2014 earnings to settle an unspecified number of product liability claims involving the company’s da Vinci surgical robot. In a press release, Intuitive said the $67 million is the estimated cost of settling claims alleging complications from surgeries performed with certain versions of the Monopolar Curved Scissors (MCS) instruments that were recalled in 2013 and with a first-generation MCS tip cover that was withdrawn in 2012. It said the estimated settlement amounts apply to legal claims that were tolled, the oldest of which dates back to October 2012.
May 28, 2015 - 11:37pmThis Comment
That's 190 women a year if it's the ACOG number and 540 if it's the FDA. All women whose cancer would be upstaged throughout her body if a morcellator is used where it'd be zero if the tumors hadn't metastasized - because the tumors would be removed whole. I can't believe you're the CEO of a website for women's health and you think this is an appropriate risk. You should be on the opposite side of this issue. And I agree that you should have said that you have a financial relationship with the company you're defending.
May 23, 2015 - 7:41pmThis Comment
Shame on you. You'd sacrifice a few women to benefit the majority. Who speaks for them?
May 23, 2015 - 6:28pmThis Comment
I think it was pretty irresponsible of you not to state your conflict up front. Intuitive Surgical is one of HysterSisters' sponsors. The fact that you are saying that the FDA is overstating the 1/352 number, and that the ACOG number of 1/1000 fibroids is cancer based on what you see around HysterSisters is also hardly statistical. Fibroids are the reason for 35% of the 540,000 hysterectomies done each year for benign conditions. You do the math. Whether it is 1/352 or 1/1000, those risks are not ok. Money has blinded you.
May 23, 2015 - 5:58pmThis Comment
Hello Kathy Kelley,
I do hope that a solution can be found. I understand the risk of potentially spreading an undiagnosed cancer with morcellation, regardless of how low the numbers. But, I can appreciate the appeal of a less invasion surgical procedure.
Regards,
April 23, 2014 - 4:43pmMaryann
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