8 Common Questions Patients Ask About Cerene®, and How to Answer Them

For women with heavy menstrual bleeding, or menorrhagia, there are a multitude of medical treatment options that could be considered depending on their condition. Whether it’s hormonal or non-hormonal medications, minimally invasive surgical treatments, or more complicated surgical procedures like hysterectomy, it’s only natural that these patients may have questions about which treatment is right for them.

With the Cerene® Cryotherapy Device emerging as an effective method of treating heavy menstrual bleeding, it’s important to prepare for questions you may receive from your patients about Cerene. This article addresses the most common questions and concerns your patients may have as they consider their options.

1) What is Cerene?

Cerene is a minimally invasive cryotherapy treatment designed to significantly reduce the symptoms of heavy periods. It uses a cooling/freezing agent to freeze and destroy endometrial cells, or the lining of the uterus, which can provide patients lasting relief from heavy bleeding and cramping.

2) Does Cerene really work?

Yes, it can really work! If heavy periods are interfering with your patient’s life, Cerene can help them take back control with a significant reduction in heavy bleeding and cramping.

Some of the promising results that Cerene patients have enjoyed include:

• 90% were satisfied with Cerene^†
• 90% had normal, light, or no periods after Cerene^†
• 86% had a reduction in cramping^‡
• 95% would recommend Cerene to family and friends^†††

3) How safe is Cerene?

Cerene is a device that is approved by the FDA for its safety and effectiveness. It is used in many OBGYN practices across the country, and has helped countless women take back control of their menstrual health.

In an FDA pivotal clinical study, Cerene was proven to be safe and effective in treating heavy periods due to benign causes in premenopausal women for whom childbearing is complete. No serious device-related adverse events were reported.

From start to finish, the Cerene device prioritizes patient safety with a variety of multi-tiered features, including:

• Cavity-conforming liner to ensure uniform cavity coverage during nitrous oxide administration
• Thermally insulating sheath to protect the cervical canal and adjacent tissues from cryoablative effects
• Controlled treatment parameters to automatically monitor and control variables, ensuring maximum patient safety
• Perforation prevention and detection to limit the chances of tissue damage
• Cryotherapy using nitrous oxide to minimize intracavitary scarring, adhesions, and contracture¹

4) What are the side effects of Cerene?

As with any procedure, there are risks related to Cerene and to the medications used during treatment.

Fortunately, side effects when using the Cerene Cryotherapy Device are mild. Patients may experience temporary side effects including uterine cramping, vaginal infection, and lightheadedness.

View full safety information.

5) What can I expect from the Cerene procedure?

One of the biggest benefits of Cerene is how simple the procedure is. Patients don’t need to plan for a trip to the hospital operating room — Cerene can be performed in the comfort of your own office, or in the site of care based on your and your patients’ preference.

The procedure only takes seven minutes total. Two-and-a-half minutes of that is the actual treatment, the rest is device insertion, safety checks, and device removal.

The treatment can feel a bit uncomfortable, but it shouldn’t be painful. Your patient won’t need general anesthesia. 92% of patients say their pain level was at or below the acceptable median pain score during the treatment.¹

In addition to the auto-anesthetic effects of cryotherapy, you may consider offering anesthesia or other medications at your discretion to ensure your patient’s comfort.

Here’s how the treatment works:

• Step 1: Insertion. The Cerene Device is gently inserted into the uterus, and safety checks are completed.
• Step 2: Treatment. Cryotherapy is delivered for 2.5 minutes to treat the endometrium, while providing a natural, pain-relieving effect.
• Step 3: Removal. At the end of the treatment and after a thawing period, the Cerene Device is carefully removed.

6) How long does recovery take after Cerene?

Patients will be back to their normal routine before they know it. Most patients can return to daily activity within 24 hours of Cerene treatment.

Patients can expect to see an improvement in their symptoms within three to six months. Learn what to expect after the Cerene treatment.

7) Will my insurance cover Cerene?

In order to determine coverage for the Cerene Cryoablation procedure, patients should contact their insurance company.

8) Why would I choose Cerene over another solution?

Patients with heavy periods have options. Unfortunately, a lot of those options are inconvenient and may result in unwanted side effects.

Hormone therapy and hysterectomy

Hormone therapy can take many forms, but none of them are particularly convenient. It could be birth control medication that your patient has to remember to take daily, an IUD that may be uncomfortable or even painful to insert, or injectables that require inconvenient trips to the doctor’s office throughout the year.²

If hormone therapy doesn’t work, a hysterectomy may be another option. Hysterectomies are an invasive procedure with long recovery times and a higher risk of complications compared to other treatment options.³

Endometrial ablation

There are two main forms of endometrial ablation: thermal and cryoablation. In both cases, ablation destroys the tissue that sheds blood each month during your patient’s period (the endometrium) and can help reduce heavy bleeding and cramps.

Heat-based technology was once the only option for ablations, but it comes with a fair share of concerning side effects. Most notably, thermal ablations can cause tissue scarring that can make it difficult or impossible for a physician to access the cavity in the future.¹

That’s what makes endometrial cryoablation with Cerene such a unique option for women with heavy periods. Instead of heat, Cerene uses cooling technology to destroy endometrial tissues and make your patient’s period lighter and less painful. The extreme cold used in the treatment is naturally pain-relieving and numbing, so patients won’t need general anesthesia or IV sedation.

Another benefit of cryoablation with Cerene is that it produces minimal uterine tissue scarring. That means that if your patient ever needs another procedure, you may have full access to the cavity and can make an easier assessment and diagnosis.¹

Cerene is a safe, effective way to help your patients take back control and get lighter, less painful periods. Learn more about the Cerene Cryotherapy Device at https://cerene.com/healthcare-professionals

Key Takeaways

• Cerene is a safe, FDA-approved device that can reduce heavy bleeding and cramping for patients with heavy periods.
• The procedure is well-tolerated and can be performed in just minutes in the comfort of a doctor’s office
• Recovery time is quick and temporary side effects are mild, so patients should be back to normal activities within 24 hours of the treatment.

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. Learn more >

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Sources:

† 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 cramping
††† Patient-reported data include definitely and consider recommending Cerene and are 1 year after treatment with durable results at 3 years

1. Curlin, H., Cholkeri-Singh, A., Leal, J.G.G., & Anderson, T. (2022). Hysteroscopic access and uterine cavity evaluation 12 months after endometrial ablation with the Cerene Cryotherapy Device. J Minim Invasive Gynecol, 29(3), 440-447. https://doi.org/10.1016/j.jmig.2021.11.016
2. About Heavy Menstrual Bleeding (n.d.). Centers for Disease Control and Prevention. https://www.cdc.gov/female-blood-disorders/about/heavy-menstrual-bleeding.html
3. Carugno, J. & Fatehi, M. (2023, January 4). Abdominal Hysterectomy. In StatPearls. StatPearls Publishing. Retrieved July 25, 2023 from https://www.ncbi.nlm.nih.gov/books/NBK564366/