Hysteroscopy In 2002, the FDA approved Essure™, a hysteroscopic method of permanent birth control, and a second hysteroscopy method, Adiana™, was approved in 2009. Both methods can be provided in an office setting, with only local anesthesia or conscious sedation and both offer the prospect of greater safety, lower cost, and greater long-term effectiveness than the best laparoscopy methods. Essure™ is a microinsert consisting of a soft stainless steel inner coil and a dynamic nickel titanium alloy outer coil (Fig. 10.14). Soft fibers of polyethylene terephthalate run along and through the inner coil. To insert the device, a hysteroscope is introduced into the uterine cavity, which is distended with saline. The tubal ostia are visualized. The Essure™ device is inserted through the operating channel of the hysteroscope on the end of a slender delivery wire, guided into the tubal opening and advanced into the tube under direct vision (Fig. 10.15). Once in place, an outer sheath is retracted, releasing the outer coils, which expand to anchor the device in the interstitial portion of the tube. The delivery wire is detached and removed and the procedure repeated for the other tube. When properly placed, three to eight of the end coils of the microinsert are visible inside the uterine cavity. The rest are inside the fallopian tube (291,292).
Figure 10.14 Essure device for hysteroscopic sterilization. (Courtesy of Conceptus, Inc.)
The Adiana™ system consists of a catheter electrode that is guided into the interstitial portion of the fallopian tube via the operating channel of a 5-mm hysteroscope (Fig. 10.16). An array of bipolar electrodes on the catheter are used to apply radio frequency electric current for 60 seconds to achieve a temperature of 64◦C, creating a superficial injury to the inner surface.
A 3.5-mm ﬂexible cylindrical silicone matrix is deployed from the catheter into the tube at the site of the thermal lesion. The same process is repeated in the other tube. A nonionic medium such as 1.5% glycine is used to distend the uterus (293).
Essure™ and Adiana™ devices can be installed under local anesthesia in an outpatient setting. No incision is needed. A nonsteroidal anti-inﬂammatory drug is given 1 to 2 hours before the procedure to decrease tubal spasm. Over time fibrous tissue grows into both devices, occluding the tubes permanently. Because of this mechanism of action, these methods depend on scar formation, and women who are immunocompromised from HIV infection, medication, or chemotherapy should be advised that their success may be lower (293,294). The FDA requires a 3-month follow-up x-ray hysterosalpingography examination to document tubal occlusion for both methods. The hysterosalpingogram (HSG) for Essure™ should document bilateral placement of the devices at the uterotubal junction and a lack of peritoneal spillage of dye. Off-label and outside of the United States, plain x-ray, ultrasound, computerized x-ray tomography, and magnetic resonance imaging were used to confirm the presence and position of the Essure™ devices (295,296). The Adiana™ matrix is not radio opaque, so successful occlusion is documented only by lack of dye spillage. The patient with transcervical sterilization should continue to use a reliable method of contraception until successful occlusion is documented.
Figure 10.15 Essure device with guide wire and handle. (Courtesy of Conceptus, Inc.)
Figure 10.16 Adiana catheter as placed for tubal sterilization. (Courtesy of Hologic, Inc.)