Heavy menstrual bleeding, also known as menorrhagia, significantly affects the quality of life for approximately 30% of women of reproductive age.1 Hysterectomy and endometrial ablation are the predominant surgical approaches to heavy menstrual bleeding, with endometrial ablation serving as a safe and effective, minimally invasive alternative to hysterectomy.2 For patients with heavy menstrual bleeding, endometrial ablation is a viable alternative to hysterectomy when conservative medical management or use of an intrauterine device (IUD) has failed to alleviate their symptoms and improve their quality of life.3 There are several modalities in which ablations can be performed that use either heat or cold-based technologies.
In this article, we will discuss the importance of candidate selection for endometrial ablation including setting patient expectations, inclusion and exclusion criteria, and the benefits of using the Cerene Cryotherapy Device for patients suffering from heavy menstrual bleeding.
Compared to hysterectomy, endometrial ablation is an appealing option for patients because it is a relatively low-risk procedure that will likely decrease their heavy menstrual bleeding to normal levels or less and help improve their quality of life.4
It is important to set expectations with patients before they undergo any procedure and while endometrial ablation is relatively safe and effective, physicians should discuss all potential outcomes with patients so that they can make an informed decision about their treatment plan. For example, along with explaining the many benefits, physicians should communicate that full results are not always immediate as this may impact the patient’s satisfaction post-procedure.5 Additionally, helping patients understand that returning to normal levels of bleeding or less, rather than amenorrhea, is also a potential outcome.
Physicians should also explain that some treatments may fail to provide relief from symptoms or lead to additional complications down the road. We see this with many heat-based modalities which studies have shown can lead to uterine scarring and contracture resulting in patients experiencing pain, bleeding, and cramping after the procedure.6 A common complaint among women who elect to have heat-based endometrial ablation is that they were not adequately informed about the possibility of late-onset endometrial ablation failure or that this could present as pelvic pain.7
By setting realistic expectations for patients before endometrial ablation, physicians can help ensure that they are satisfied with the outcomes and avoid unnecessary disappointment or frustration following their treatment.
There are several factors documented in current literature that have been shown to be risk factors for endometrial ablation failure and should be considered prior to selecting a patient for endometrial ablation.7 When patients are appropriately selected, the risks of serious complications are minimized, and the outcomes are optimized.8 In general, the following considerations are important in determining who is an appropriate candidate for a successful endometrial ablation7:
Cryoablation, using the Cerene Cryotherapy Device, has been shown to be a safe and effective endometrial ablation treatment for women providing some clear therapeutic advantages such as:
Because cryoablation, or cold therapy, creates a tissue healing effect different from thermal, or heat-based treatments, there is the potential of decreased risk of adhesion formation.11 In most cases, physicians who use Cerene to treat heavy menstrual bleeding in their patients are able to adequately access the uterine cavity to assess for abnormal uterine bleeding or endometrial cancer post-procedure.12
The Cerene Cryotherapy Device offers a safe and effective in-office treatment for women seeking endometrial ablation for heavy menstrual bleeding.
* Patient-reported data are 1 year after treatment with durable results at 3 years
† Improvement reported one year after treatment for patients reporting severe/very severe period pain
Important Safety Information
Cerene® Cryotherapy Device is indicated to ablate the endometrial lining of the uterus in premenopausal women with heavy menstrual bleeding due to benign causes for whom childbearing is complete. Pregnancy following the Cerene procedure can be dangerous; therefore, contraception must be used until menopause. The Cerene procedure is not for those who have or suspect uterine cancer; have an active genital, urinary or pelvic infection; or an IUD. There are risks and considerations associated with the use of the Cerene Cryotherapy Device. Temporary side effects may include uterine cramping, vaginal infection, and lightheadedness. For detailed benefit and risk information, consult the Cerene Instructions for Use (IFU) or your healthcare professional. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician trained in the use of the Cerene Cryotherapy Device.