Acessa Procedure for the Treatment of Fibroids

Dr. Odom is the first physician in Columbia to perform the Acessa procedure.

The Acessa Procedure

• Outpatient procedure that shrinks or completely eliminates fibroids while keeping a healthy uterus
• Rapid and significant reduction of symptoms
• Quick recovery—3 to 5 days
• Extremely high patient satisfaction
• Very low need for further treatment
• FDA-cleared system

The Acessa Procedure is a minimally invasive, same-day, outpatient procedure that shrinks or completely eliminates fibroids. With this laparoscopic procedure, there is a rapid and significant reduction in symptoms, and recovery is fast. You can return to normal activities and enjoy a greatly improved quality of life, without undergoing a hysterectomy. And with the Acessa Procedure, there is a very low need for further treatment.

The Acessa Procedure uses a technology called radiofrequency ablation. Each fibroid is destroyed by applying energy through a small array needle. The surrounding tissue is not affected. The destroyed tissue may then be completely reabsorbed.

Frequently Asked Questions About Acessa

Is Acessa Covered By Insurance?

Acessa is covered by many insurance carriers. The first step if you are interested in Acessa is to contact a physician who offers Acessa and schedule an initial consultation. After you have a consultation with a physician and determine if you are a candidate for the procedure, they can help you understand the benefits and coverage for Acessa.

How can I check if Acessa is covered by my insurance carrier?

1) Call your insurance carrier (phone number on the back of the insurance call).

2) Ask if laparoscopic radiofrequency ablation of uterine fibroids is covered under their medical policy.

You may need to reference the CPT code 58674. Note, we have heard from some patients that they have received incorrect information from the insurance call centers. Thus, we suggest scheduling an appointment with an Acessa physician and going through the formal process of prior authorization.

It is covered by my insurance, how much will it cost?

We are unable to provide a quote because every benefit plan is different. Your insurance company and the physician’s office are the best resources to provide a price quote. Typically, the out of pocket cost is the same as your deductible.

It is not covered by my insurance, is there an appeals process?

Note, we have heard from some patients that they have received incorrect information from the insurance call centers. Thus, we suggest scheduling an appointment with an Acessa physician and going through the formal process of prior authorization. After the initial consultation, if you are a candidate for the procedure, your physician’s office will submit a pre-authorization to your insurance for the procedure.

If your pre-authorization is denied, we have dedicated support to help the appeals process. The only way to initiate the appeals process is after you have a consultation with an Acessa physician. The appeals process takes 2-4 months and does not always result in positive coverage.

Can Acessa treat large fibroids?

It is your doctor’s decision to decide if he or she can safely and effectively treat your fibroids. Acessa has studied up to 10cm fibroids and commercially physicians have treated larger. If you have fibroids larger than your doctor feels comfortable treating, he or she may refer you to another Acessa surgeon who has more experience with those cases.

Is there a limit to the number or quantity of fibroids that can be treated?

The physician can treat any number of fibroids present. In fact, many physicians say the ability to treat more fibroids thanks to laparoscopic ultrasound image is an advantage of Acessa compared to myomectomy.

Can Acessa be used to treat any type of fibroid in any location?

Acessa can be used to treat nearly all fibroid types, including subserosal, intramural, transmural, and submucosal. Acessa is not recommended for pedunculated fibroids that have a stalk < 50% of the total diameter of the fibroid. Pedunculated fibroids that have a stalk >50% of the total diameter of the fibroid can be treated with Acessa at the discretion of the surgeon.

How can I figure out what types of fibroids I have?

Typically, patients and physicians determine the type of fibroids and locations using an MRI or transvaginal ultrasound (TVUS), when determining diagnosis and treatment plan. If you have already received an MRI or ultrasound, but do not know what type of fibroids or the location of your fibroids, we encourage you to ask your doctor for a written list of types and locations of the fibroids.

Is there an age limit?

No, most women who seek the surgery are pre-menopausal. Acessa studied women 25 years and older. The study population included women up to 55 years old. As a reminder, Acessa is a treatment for benign (non-cancerous) symptomatic fibroids. If patients are at risk for cancer, or malignancy, Acessa is not the appropriate treatment.

Is Acessa recommended for women who want to have future pregnancies?

Insufficient data exist to evaluate the safety and efficacy of the Acessa Procedure for women who are seeking future pregnancy. Therefore, the Acessa Procedure is not recommended for women who are planning future pregnancies.

Have women have gotten pregnant after using Acessa?

Yes, there are publications on this topic. Patients should discuss the safety of all available treatment options to treat their fibroids with their physician.

What is the Acessa Procedure?

The Acessa Procedure, also known as laparoscopic radiofrequency ablation (RFA), is an outpatient procedure (i.e., go home from the surgery the same-day) performed under general anesthesia (i.e., patients are asleep during surgery) to treat uterine fibroids. It is a minimally invasive alternative to hysterectomy, myomectomy and uterine artery embolization (UAE) for uterine fibroids. Acessa utilizes radiofrequency ablation (heat) under laparoscopic ultrasound guidance to shrink or eliminate the fibroid, without harming healthy uterine tissue. The Acessa Procedure allows the physician to treat almost all fibroids regardless of size and location. See “How does the Acessa procedure work?” for more information on how the procedure works.

Radiofrequency ablation is a technique used in other procedures to destroy tumor tissue, including liver ablation.

What should I expect on the day of surgery?

• After arriving at the hospital or surgery center, the nurses will prep the patient for surgery and be brought to the operating room.
• In the operating room, an anesthesiologist will give the patient medicine to fall asleep – general anesthesia.
• The surgery team will prepare the patient and the instruments for surgery and begin the procedure.
• The procedure starts with two small incisions in the abdomen. One in the belly button, then a second at the bikini line. The incisions are typically less than 1/4 of an inch in diameter. These are the ports the surgeon will use for his or her instruments. Again, the patient will be asleep for all of this.
• The surgeon will primarily use three sterilized instruments:
  • Laparoscopic camera – a camera with a light that is used to see inside the body. Many procedures use a laparoscopic camera.
  • Acessa Transducer probe – an ultrasound probe that is used to see inside the uterus to find fibroids. The Acessa transducer probe is integrated in the Acessa system and designed specifically for this procedure.
  • Acessa Handpiece – a needle inserted through the skin, used for treating the fibroid focally with heat.
• After the surgery, the surgeon will close the small incisions using stitches. Patients will still be asleep under general anesthesia.
• After waking up, patients typically do not feel post-operative pain. Most patients stay at the hospital or surgery center for 1-2 hours before returning home and are sent home on a Tylenol.
• The surgeon will speak with the patient about the surgery and discuss next steps.
• Most patients are back to normal activity in 3-5 days.

What steps are involved in the actual Acessa procedure?

Using the three instruments previously discussed, the surgeon treats each fibroid individually with radiofrequency energy (heat) that is specifically controlled to destroy the fibroid and leave the surrounding tissue unharmed.

The Acessa Procedure involves three basic steps:

If the fibroids are not physically removed, how does Acessa work?

As a reminder, Acessa is a treatment for benign (non-cancerous) symptomatic fibroids. If patients are at risk for cancer, or malignancy, Acessa is not the appropriate treatment.

Studies show that fibroids do not have to be completely removed to solve symptoms. Killing the fibroid cells so they shrink and stop putting pressure on the uterus can solve symptoms. It has been proven that even a 10% reduction in fibroid volume can result in significant improvement in heavy periods, pelvic pain and bulk.

To summarize, Acessa works by heating the fibroid cells from the inside out, not by removing the fibroid. Cell tissues die when they reach a certain temperature. Acessa heats the fibroid tissue to the point that it dies. The dead fibroid tissue shrinks and shrivels. The dead tissue is not harmful. It gets absorbed by the body, just like any dead tissue cell.

What happens to the fibroid? How much do they shrink?

Once the fibroid is treated, the destroyed fibroid tissue shrinks. Depending on the size and location of the fibroid, some fibroids may completely go away, where the others will not have any associated symptoms. Total volume shrinkage is dependent on fibroid size and location. From our clinical studies, there was an average of 45% decrease in fibroid volume at 12 months after the procedure. Fibroids continue to shrink after 12 months.

Do the fibroids come back after the procedure?

After the fibroid is treated with Acessa, typically that particular fibroid will not return. However, it is possible to grow new fibroids after the procedure is performed.

What does laparoscopic mean?

Laparoscopic surgery is a minimally invasive surgical technique where surgical tools are operated through small keyholes in the body and a camera (laparoscope) is used to see inside the body. Laparoscopic means there are only small incisions compared to an open procedure where the surgeon cuts a longer incisions.

Am I asleep during the procedure?

Yes, the procedure is performed under general anesthesia. Patients are not awake during the procedure. The procedure cannot be performed under local anesthesia.

Can the procedure be performed in the office?

No, the procedure cannot be performed under local anesthesia nor in an office setting. Most office procedures do not have the ability to visualize and treat a wide variety of size, location and number of fibroids. Acessa can be performed at an Ambulatory Surgery Center or a hospital.

How long does the procedure take?

Each procedure varies in length based on the number and size of fibroids. Typically, the entire procedure from anesthesia to waking up lasts 45 minutes to 1.5 hours.

Is the Acessa Procedure painful?

Most patients do not experience post-operative pain following the procedure. Typically, patients go home on NSAIDs such as Tylenol 3 and are back to normal activity in 3-5 days.

What are the Typical Results?

Most patients report they have significantly lighter periods, alleviated pelvic pain and pressure. Often patients who experience “bulking” – looking pregnant/ distended abdomen from the fibroids, report reduced or eliminated bulk symptoms. Women often report back that they “love Acessa!”. To hear directly from patients, search “Acessa” on YouTube.

The results of the Overall Treatment Effect Survey of the Pivotal study of 124 patients showed that 94% of the subjects responded that they were very satisfied, moderately satisfied, or somewhat satisfied with the treatment. At 12‐months post-treatment, 98% of the subjects reported that they would probably or definitely recommend the procedure to their friends with the same health problem. When asked about the effectiveness of the treatment, at least 94% of the subjects responded that the treatment had been somewhat, moderately, and very effective in eliminating their symptoms.

When will patients feel symptom relief?

Most patients feel symptom relief right away. Most patients see the greatest effects 3-6 months after Acessa. Some patients report a heavier period their first two periods after the surgery, then bleeding returns to baseline around the 3-month mark. To hear directly from patients, search “Acessa” on YouTube.

Based on our clinical data, the average reduction in menstrual blood loss was 87ml less blood than baseline periods after 3 months and reduced even further to 110 ml less by 6 months.

How safe is the Acessa Procedure? Is it clinically proven?

Laparoscopic RFA was first performed on fibroids in 1999 by Dr. Bruce Lee. After many successful studies, the original Acessa System was FDA cleared in November 2012. Since 2012, physicians have performed over 3,000 procedures to date. The newest, most advanced technology, the Acessa ProVu system, was cleared in 2018.

The Acessa Procedure is clinically proven. There are over 29 peer-reviewed studies that show Acessa as a clinically proven, safe and effective for the treatment of uterine fibroids. In fact, in three separate clinical studies leading up to FDA clearance, the complication rates were extremely low (<4%). Your physician can explain the potential complications of the Acessa Procedure, as well as those of other available fibroid therapies.

What is the difference between Uterine Artery Embolization (UAE) vs Acessa?

UAE involves ischemic necrosis which consists of the tissue slowly dying due to lack of blood supply (like tying a rubber band around your finger and waiting for it to fall off), and typically involves an overnight stay for pain management. Acessa uses coagulative necrosis which destroys the fibroid cells and nerve endings with heat right away, thus minimal pain is associated with the Acessa Procedure compared to UAE. Acessa patients may return home the same day.

UAE is performed by interventional radiologists. The Acessa procedure is performed by minimally invasive gynecologic surgeons.

What is the difference between Myomectomy vs Acessa?

Myomectomy involves cutting fibroids and removing the fibroid tissues from the uterus. Acessa, by comparison, does not require cutting or suturing within the uterus. Myomectomy is often considered a minimally invasive surgery because the incisions into the abdomen are small. Most physicians who offer Acessa and myomectomy, consider Acessa as a less invasive option because there are zero incisions on the uterine surface (serosa), and only 2 small incision on the skin (myomectomy has 4 to 6 incisions in the skin).

Can Acessa be combined with other procedures?

Yes, it is also known as concomitant or combination procedures. Acessa can be used as another tool for treating fibroids. For example, your physician may recommend a myomectomy + Acessa – removing some fibroids using the myomectomy technique and destroying others with the Acessa procedure. Acessa may also be performed after hysteroscopic procedures.

Why Haven’t I Heard About Acessa Before?

Laparoscopic RFA was first performed on fibroids in 1999 by Dr. Bruce Lee. After many successful studies, the original Acessa System was FDA cleared in November 2012. Since 2012, physicians have performed over 3,000 procedures to date. The newest, most advanced technology, the Acessa ProVu system, was cleared in 2018.

One of the reasons patients may have not heard about Acessa, is because some insurance companies do not cover the procedure. We are working on changing that. As we receive more coverage we will expand to new areas. For comparison, uterine artery embolization is still considered a ‘newer technology’ and it was approved 10 years before the Acessa Procedure for fibroids in 2002.