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SHARING IS CARING

HysterSisters Founder Writes to FDA

From the Hysterectomy News Articles List

April 28, 2014

To: FDA Regarding GYN Morcellation Safety Communication:

My name is Kathy Kelley and I am the founder and CEO of HysterSisters--a woman-owned, "social advocacy" health education company dedicated to medical and emotional issues surrounding the hysterectomy experience and gynecologic-related conditions and illnesses, supporting women from diagnosis, to treatment, to recovery. Since 1998, HysterSisters has provided personalized support, dispersed educational materials, and conducted research--all at no cost to the women who visit our website. HysterSisters currently has over 330,000 members.

I am writing in response to the FDA safety communication restricting the use of morcellation in GYN surgeries. The FDA and I share the goal of protecting patients, ensuring them a safe surgery for their GYN conditions that require treatment, but we seem to differ on how this is achieved for this particular issue.

FACTS AND STATS
  • Around 600,000 hysterectomies are performed in the United States each year. (a)
  • Morcellation is used in 11% of hysterectomies, or in 110 for every 1,000.(b).
  • 1 in 1,000 women with fibroids, or 0.1%, will be found to have uterine leiomyosarcoma (ULMS). (c).
  • Death will occur for 1 in 1,000, or 0.17%, of hysterectomies for a benign reason.(d)
  • The risk of ULMS is no more than 0.49%.(e)
The FDA reported that ULMS occurs in 1 out of 350 women with fibroids. However, the American Congress of Obstetricians and Gynecologists (ACOG) and the American Cancer Society report a much smaller statistic of about 1 in 1,000 in women with fibroids. Our own HysterSisters member surveys, with 167,000+ participating members (as of April 26, 2014), support the percentage 1 in 1000 women with fibroids.

THE CHOICES LEFT TO US - ILLOGICAL ALTERNATIVES

The FDA summarized: A number of additional treatment options are available for women with symptomatic uterine fibroids including traditional surgical hysterectomy (performed either vaginally or abdominally) and myomectomy, laparoscopic hysterectomy and myomectomy without morcellation, laparotomy using a smaller incision (minilaparotomy), deliberate blocking of the uterine artery (catheter-based uterine artery embolization), high-intensity focused ultrasound, and drug therapy. The FDA recommended: Be aware that based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids.

If power morcellation is unsafe for a woman because she carries an unacceptably high risk of having an occult cancer, then it is illogical to offer her endometrial ablation, uterine artery embolization, manual morcellation by any route, or myomectomy. These treatments either spread cancer, leave it in place untreated, or both. The FDA recommendation is illogical and incongruent with patient outcome goals.

THE CHOICES LEFT TO US - RISKIER SURGERIES

Without morcellation, women's choices are severely limited and may require riskier surgeries to treat their conditions--even those without fibroids. The risks for some complications, such as deep venous thrombosis and pulmonary embolism, infection and sepsis, fascial dehiscence and bowel obstruction, are higher with an abdominal surgery. Will we save a few women with undiagnosed cancer but harm thousands more who do not have cancer?

HYSTERSISTERS BOTTOM LINE

HysterSisters believes it is the shared responsibility of the physician and patient to weigh the risks and benefits of the choices in minimally invasive surgery for the individual patient. With the ultimate goal being the best outcome for the patient, women should be counseled about the risks associated with morcellation with full disclosure. This means decisions regarding methods of tissue extraction, whether bagged or unbagged, through laparotomies or the vagina, or laparoscopically via power morcellation, should remain between the surgeon and patient.

Women should not have to revert back to their mothers' hysterectomy experience of higher risks and longer recoveries. Instead, we should look forward to advancements in gynecologic health, including earlier diagnosis, safer minimally invasive surgery methods for removing tissue, and overall more effective treatments for gynecologic cancers. We encourage the FDA to seek the counsel of ACOG and AAGL as the industry authorities on this matter.


Sincerely,


Kathy Kelley
HysterSisters.com


---------------------------------------
Kathy Kelley founder of HysterSisters
If you would like to communicate to the FDA about this decision, please visit this FDA contact page or call: 1-888-INFO-FDA (1-888-463-6332)

Or write:
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002

If you are a patient and have been denied surgery by your surgeon because of new hospital policy restricting minimally invasive surgery because of this morcellation issue: contact the hospital directly to let them know your thoughts and consider exploring other hospital choices, if available.



(a) ACOG Task Force Report Morcellation and Occult Malignancy
(b) ACOG Choosing the Route of Hysterectomy for Benign Disease
(c) SGO Position Statement - Morcellation
(d) Hysterectomy: Mortality Linked to Complication Management
(e) JAMA - Evaluating the Risk of Electric Uterine Morcellation

Edited May 27, 2014 to include links to statistical data reports.




04-28-2014 - 04:13 PM


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