Frequently Asked Questions
WHO IS A GOOD CANDIDATE FOR THE PROCEDURE?
Can Acessa treat large fibroids?
Technically there is no limitation to how big your fibroids can be to use Acessa. However, it is your doctor’s decision to decide how big they can safely treat each fibroid. If the physician cannot introduce the necessary instruments into the abdomen during surgery, they will not be able to safely treat your fibroids. We have studied up to 10cm fibroids, commercially we have treated up to 16cm fibroids.
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 voice that an advantage of Acessa compared to myomectomy is the ability to treat more fibroids, including fibroids near the cervix. Due to the highly sensitive laparoscopic ultrasound image.
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 digression 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.
Is Acessa recommended for women who want to have future pregnancies?
Insufficient data exists 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 pregnancy.
WHAT IS THE PROCEDURE?
What is the Acessa Procedure?
The Acessa Procedure 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). It is a minimally invasive outpatient procedure to treat symptomatic uterine fibroids. It is an alternative to hysterectomy, myomectomy and uterine artery embolization (UAE) for uterine fibroids. Acessa is a minimally invasive surgery that utilizes radiofrequency ablation 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.
What should I expect the day of surgery?
- After arriving at the hospital or surgery center, you will prep for surgery and be brought to the operating room.
- In the operating room, an anesthesiologist will give you medicine to fall asleep – general anesthesia.
- The surgery team will prepare you and the instruments for surgery and begin the procedure.
- The procedure starts with two small incisions in the abdomen, typically less than ¼” in diameter. One in the belly button, then a second at the bikini line. These are the ports the surgeon will use for his or her instruments. Again, you will be asleep for all of this.
- Your 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 long probe with a needle at the tip used for treating the fibroid focally with heat.
- See the next question, “How does the Acessa procedure work?” for more information on how the procedure works.
- After the surgery, your surgeon will close the small incisions using stiches. You will still be asleep under general anesthesia.
- When you wake up, you will not feel post-operative pain. Most patients stay at the hospital or surgery center for a 1-2 hours before returning home.
- Your surgeon will speak with you about the surgery and discuss next steps.
- Most patients are back to normal activity in 3-5 days.
How does the Acessa procedure work?
Using a small scope and ultrasound guidance, the surgeon treats each fibroid individually with radiofrequency energy that is specifically controlled to destroy the fibroid and leave the surrounding tissue unharmed.
The Acessa Procedure involves five basic steps:
(1) Two tiny incisions are made in the abdomen, typically less than ¼” in diameter in the belly button, then a second at the bikini line.
(2) A laparoscopic ultrasound probe is used to determine the location and size of all fibroids present.
(3) The Acessa handpiece tip is then advanced into the fibroid using ultrasound guidance.
(4) The electrode array on the tip of the handpiece is then deployed into the fibroid.
(5) Energy is applied based on the size and location of the fibroid, destroying the fibroid. No incisions are made in the uterus and no tissue is removed.
The surgeon alternates between scanning the uterus with the transducer and heating tissue with the handpiece until all fibroids have been treated. Before finishing the procedure, your surgeon will scan your uterus with the ultrasound probe to ensure he or she has treated all the fibroids.
What does laparoscopic mean?
Laparoscopic surgery is a modern surgical technique where surgical tools are operated through small keyholes in the abdomen and a camera (laparoscope) is used see inside the body. Laparoscopic means there are only small incisions compared to an open procedure where the surgeon cuts a longer incision along the abdomen.
Am I asleep during the procedure?
Yes, the procedure is performed under general anesthesia, so you 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. It 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. On average, the procedure is completed in 1-1.5 hours.
Is the Acessa Procedure painful?
Patients do not experience post-operative pain following the procedure. Typically, patients go home on a NSAIDs such as Tylenol 3, and are back to normal activity in 3-5 days.
WHAT ARE THE TYPICAL RESULTS?
What are typical results?
Most patients report they have significantly lighter periods, alleviated pelvic pain and pressure. Patients who experience “bulking” – looking pregnant/ distended abdomen from the fibroids, often report reduced or eliminated bulk symptoms. We often get women who report back that they “love Acessa”! See our patient testimonials [LINK] to hear directly from patients.
When will patients feel symptom relief?
Most patients feel symptom relief right away. Most patient 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. We recommend reading and listening to our patient testimonials to hear directly from patients about their experience with Acessa. [LINK]
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.
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. It has been proven that even a 10% reduction in volume can result in significant improvement in symptoms.
From our clinical studies, there was an average of 44% decrease in fibroid volume at 12 months post op. Fibroids continue to shrink after 12 months. Total volume shrinkage is dependent on fibroid size and location.
Do the fibroids come back after the procedure?
After the fibroid is treated with Acessa, that particular fibroid will not return. However, it is possible to grow new fibroids after the procedure is performed. Most Acessa patients do not a second surgery or re-intervention after their Acessa procedure.
WHAT INFORMATION IS AVAILABLE ABOUT THE PROCEDURE?
How safe is the Acessa Procedure? Is it clinically proven?
The FDA has cleared the Acessa Procedure for the treatment of uterine fibroids in 2012. The Acessa Procedure is clinically proven. There are over 30 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. See a bibliography of studies on Acessa here [LINK].
Why is it not recommended for women who are seeking future pregnancy, my doctor said women have gotten pregnant after using Acessa?
Patients should discuss fertility with their physicians. Acessa Procedure is not recommended for women who are planning future pregnancy at this time.
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, thus minimal pain is associated with the Acessa Procedure compared to UAE and patients may return home the same day.
UAE is also 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 stitches 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.
Can Acessa be combined with other procedures?
Yes, we call it concomitant or combination procedures. Acessa is often used as another tool in the toolbox 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 with hysteroscopic procedures as well, such as an endometrial ablation or hysteroscopic resection.
WHY HAVEN’T I HEARD ABOUT ACESSA BEFORE?
How long has this option been available, and why has my doctor never heard of it?
Acessa was first performed in 1999 by the inventor, Dr. Bruce Lee. After many successful studies, Acessa was FDA cleared in November 2012. Since 2012, we have performed over 3,000 procedures to date.
We have only trained a handful of skilled physicians (approx. 50) across the country since it is a newer technology. Many doctors have never heard of it because it is a newer technology. We are also limited by insurance coverage. 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. More and more physicians are learning about Acessa – we are growing daily.
WHERE CAN I GET THE PROCEDURE?
Where is the procedure offered in the US?
We are growing and expanding daily. Check back to see where we grow!
Minimally invasive gynecologic surgeons across the United States offer the procedure. We encourage you to call their offices, mention you found them through the Acessa website and make an appointment. See the list of surgeons who offer Acessa here [link to pdf with list] or you can search your zip code here [physician finder]
Currently we have physicians in the following cities who offer the Acessa procedure:
- Dallas, TX
- Austin, TX
- Fort Worth, TX
- San Antonio, TX
- El Paso, TX
- Albuquerque, NM
- Beverly Hills, CA
- San Francisco, CA
- Chicago, IL
- Detroit, MI
- New York, NY
Is it offered outside the US?
The Acessa procedure is currently not offered outside the US. Many patients travel internationally to the US to physicians who offer cash-based bundles for Acessa. If you are interested, please reach out to the physician offices for quotes and more information.
I’m from Canada, Is there a waitlist I can get added to?
The Acessa Procedure for fibroids is not offered in Canada at this time.
Dr. Thiel at University of Saskatchewan will begin offering the Acessa Procedure again as soon as the new technology is approved by Health Canada. We are hopeful that will happen summer of 2019. In the meantime, he is taking consults and has a waiting list for the procedure. You can contact him at: email@example.com. He is the only physician in Canada taking consults and waiting list at this time
There are no physicians in my area who offer the procedure, what should I do?
Many women travel for the procedure.
Some of physicians are accustomed to working with patients who are traveling. We recommend reaching out to any Acessa physician office to learn more about their policies and your insurance coverage in that city. The list of all our physicians is here [link to pdf with list of physicians]
Can my current physician do the Acessa Procedure even if he or she is not on your list?
Most patients choose to see another physician who offers Acessa for their surgery, then they return to their original OBGYN for ongoing care. If your doctor has never heard of the Acessa Procedure for fibroids, we encourage you to tell them about the procedure. However, please note that not all OBGYN physicians are trained in minimally invasive surgery. Thus, not all OBGYN’s will be able to offer the Acessa procedure. If your physician is interested in being trained on the procedure, please have him or her reach out to Acessa Health at firstname.lastname@example.org.
IS IT COVERED BY INSURANCE?
Is it covered by insurance? How much does it cost?
Acessa is covered by many insurance carriers. The best way to check if it is covered by your insurance provider is to call your carrier and ask if it is covered. You may need to reference the procedural code (CPT code) 58674 when you call. Every benefit plan is different – so if you’re using insurance to pay for the procedure, your insurance company is the best resource to provide a price quote.
What if it is not covered by insurance? How much does self pay cost?
If it is not covered by your insurance carrier, we have dedicated support to help the appeals process. We also have physicians who offer cash, self-pay options at ambulatory surgery centers (e.g., less expensive than hospitals).
The cost varies by physician, location (hospital or surgery center) and region. As a medical device company, we are unable to provide quoted costs due to industry regulations. The best way to get self-pricing information is to call the an Acessa physician’s office and request quote information. For some offices, an initial consult is needed before the office can provide a price quote.
DID WE MISS YOUR QUESTION?
Contact us at email@example.com
Please note that as a medical device company, we are unable to provide individual medical advice (e.g., “is Acessa right for me?”) nor pricing quotes (“e.g., “How much will this cost?”). The best way to get your questions answered is to schedule a consultation with an Acessa physician by calling their offices.
If you have trouble reaching someone at their offices, please let us know and we will help connect you. firstname.lastname@example.org
Please allow 1-4 business days for responses