The Benefits of the Acessa® Procedure

The Acessa procedure has been studied on 400+ patients and deemed a “safe and effective” treatment for uterine fibroids.1,2  Hear from women themselves about the benefits of the procedure and the doctors who treated them.

As With Any Procedure, There Are Risks

The Acessa procedure is generally safe, but complications may occur and can be serious. Risks and complications associated with the Acessa procedure include, but are not limited to: skin burns from the dispersion of radiofrequency energy, mild intra‐operative bleeding, transient urinary retention or urinary tract infection, adhesion formation, post‐procedural discomfort (cramping, pelvic pain), and transient amenorrhea, infection, injury to adjacent structures, vaginal bleeding and temporary anemia, blood loss requiring transfusion or hysterectomy, pneumothorax, wound dehiscence, deep vein thrombosis and pulmonary embolus, treatment failure, and complications related to laparoscopy and/or general anesthesia including death.

Insufficient data exists on which to evaluate the safety and effectiveness of Acessa procedure in women who plan future pregnancy. Therefore, the Acessa procedure is not recommended for women who are planning future pregnancy. There is limited data regarding pregnancy following the Acessa procedure. If you become pregnant following the Acessa procedure, you should contact your doctor immediately.

Talk with your doctor about the risks and benefits of surgery and find out if Acessa may be right for you.

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Fast-Fact Q&A

Many insurance companies and Medicaid carriers cover the procedure. We understand that some patients have received incorrect information from insurance call centers. We suggest scheduling an appointment with an Acessa- trained physician to discuss whether the procedure is appropriate for you. If the Acessa procedure is a match for your fibroid treatment, then your physician’s office will request insurance approval in advance by submitting a pre-authorization request.

The Acessa procedure can be used to treat almost all types of symptomatic uterine fibroids, including subserosal, intramural, transmural, and submucosal.1 The Acessa procedure should not be used on non-uterine masses.

In clinical studies, patients were able to return back to work within 4-5 days.1 Results may vary.

Studies show that fibroids do not have to be completely removed to resolve symptoms.1,3 Treating the fibroid cells so they shrink and stop putting pressure on the uterus may help to resolve symptoms. The data in the IDE clinical study showed even a 45.1% average shrinkage in fibroid volume can result in significant improvement in heavy periods, pelvic pain and bulk.1

The Acessa procedure is designed to heat the fibroid tissue to the point that the tissue dies. The dead fibroid tissue is not harmful. It shrinks and shrivels over time and gets absorbed by the body, just like any dead tissue cell.4

Each procedure varies in length based on the number and size of fibroids. Typically, the entire procedure from anesthesia to waking up lasts 1-2 hours.5 It may take longer for more fibroids or complications. Results may vary.

Radiofrequency ablation has been used for decades. The idea for laparoscopic radiofrequency ablation (Lap RFA) to treat fibroids, or the Acessa procedure, was first conceived by Dr. Bruce Lee in 1999.6 The original Acessa System was FDA cleared in November 2012. Since 2012, physicians have performed over 3,500 procedures with over 48 publications.7 The newest, most advanced technology, the Acessa ProVu system, was cleared in 2018. “Our analysis indicates that Lap RFA is associated with low complication rates, minimal EBL, and low reintervention rates. In addition, patients reported major improvement in their HRQL and symptom severity scores compared to reports of more traditional interventions, such as hysterectomy, myomectomy, and UAE.” Havryliuk Meta Analysis JSLS 20178
The results of the Overall Treatment Effect Survey of the pivotal study of 124 patients showed that 94% responded that they were very satisfied, moderately satisfied, or somewhat satisfied with the treatment. At 12 months post-treatment, 98% 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% responded that the treatment had been somewhat, moderately, or very effective in eliminating their symptoms. Most patients report they have significantly lighter periods and alleviated pelvic pain and pressure. Often, patients who experience “bloating”—looking pregnant having a distended abdomen from the fibroids, report reduced or eliminated bulk symptoms.1 However, results may vary.

The Acessa procedure is able to resolve many of the common fibroid symptoms, including: extreme periods, stomach swelling and bloating, leg and back pain, stomach and pelvic pain, digestive issues, anemia, pain during sex, frequent urination. 

Based on our clinical data, the average reduction in menstrual blood loss was 87 mL compared to baseline periods after 3 months and reduced even further to 103.6 mL by 6 months.1 According to HealthLine, 103.6 mL of period blood is equivalent to reducing a period by approximately 20 tampons.

Most patients see the greatest effects 3-6 months after the Acessa procedure.1,9 However, results may vary.

Availability of the Acessa procedure is expanding. Meanwhile, some physicians are accustomed to working with women who travel for the procedure. You can find Acessa-trained physicians by clicking here: Find a Physician.

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Important Safety Information

The Acessa ProVu system is intended to identify and shrink symptomatic uterine fibroids. The Acessa ProVu system is used by trained physicians during laparoscopic surgery under general anesthesia. Rare but serious risks of this procedure include, but are not limited to, infection, internal injury, blood loss and complications related to laparoscopic surgery and/or general anesthesia. This procedure is not recommended for women who are planning future pregnancy. This information is not medical advice. Please discuss the risks and benefits with your doctor to find out if the Acessa procedure may be right for you.

References

1. Chudnoff SG, Berman JM, Levine DJ, Harris M, Guido RS, Banks E. Outpatient procedure for the treatment and relief of symptomatic uterine myomas. Obstet Gynecol. 2013;121(5):1075-1082. 2. Lin L, Ma H, Wang J, et al. Quality of life, adverse events, and reintervention outcomes after radiofrequency ablation for symptomatic uterine fibroids: a meta-analysis. J Minim Invasive Gynecol. 2019;26(3):409-416. 3. Bradley LD, Pasic RP, Miller LE. Clinical performance of radiofrequency ablation for treatment of uterine fibroids: systematic review and meta-analysis of prospective studies. J Laparoendosc Adv Surg Tech A. 2019;29(12):1507-1517. 4. Acessa ProVu Instructions for Use, ProVu Users Guide PL-01-0040. 5. Braun KM, Sheridan M, Latif EZ, et al. Surgeons’ early experience with the Acessa™ procedure: gaining proficiency with new technology. International journal of women’s health. Int J Womens Health. 2016;8:669-675. 6. Interviews with Dr. Bruce Lee, inventor of the idea of using laparoscopic radiofrequency ablation for fibroids. 7. Acessa Health Corporate data, proprietary system. 8. Havryliuk Y, Setton R, Carlow JJ, Shaktman BD. Management of symptomatic fibroids: review and meta-analysis of the literature. JSLS. 2017;21(3):e2017.00041. 9. Robles R, Aguirre V, Argueta Al, Guerrero MR. Laparoscopic radiofrequency volumetric thermal ablation of uterine myomas with 12 months of follow-up. Int J Gynaecol Obstet. 2013;120:65-69.