Page 41 - World's Most Popular Laparoscopic Journal
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Bharathi Rajanna
of alternative contraception for 12 weeks. The women are cause serious problem. It is wise to keep intrauterine pressure
discharged on the same day with follow-up date. below 100 mm Hg. Hypercarbia, acidosis and air embolism
may be encountered if carbon dioxide is used in office
STUDY SUMMARY hysteroscopy.
Local anesthesia occasionally may cause allergic
Phase 1 trial revealed that 85% had successful placement,
98% had satisfactory rate and bilateral block demonstrated. reaction. The most common complications are due to
In retrospective study from 2002 to 2008 in Netherlands, intravasation.
10 unwanted pregnancies occurred which could be due to DEVICE IN DEVELOPMENT
expulsion of device (2.9%), perforation (1%). Other reasons
could be due to inadequate interpretation of HSG, Adiana Complete System
noncompliance of physician or defaulted follow-up. After It is a two stage procedure. In the first instance the
modification of device by innovating hydrophilic coating intramural part is treated with radiofrequency energy
and improved flexibility, the success of cannulation was (Fig. 6). The second step is the placement of porous silicone
98%. Phase 2 trail revealed 96% correct device placement. nonbiodegradable matrix, a size of grain is inserted into the
One patient expelled the device and in other device was tubal lumen. The implant provokes a fibrous reaction and
placed in myoma. In phase 3 trial, 11 were declined due occludes the tube over the period of week.
uterine polyp, blocked ostia and cervical stenosis. Procedure involves a flow hysteroscope, the 5F catheter
is placed in 6F working channel. A black mark on catheter
RESULTS assures correct placement. Later, radiofrequency generator
First study of safety was established in 2001. Over 50,000
procedures have been formed worldwide with 12,000 in
Europe, where 600 surgeons were trained in the technique.
Recently accepted FDA data indicates 99.7% effetiveness
with usage over 5 years.
Adverse Effects
No method is 100% effective. There is a possibility of
ectopic pregnancy. Postprocedural pain (1-3%) resolved in
one to three days. Mild vaginal bleeding lasted upto one Fig. 6: The Adiana system
week. Perforation (1%) could be due to support catheter,
which was later abandoned. A case of pyosalpinx noted is activated at tubal ostia.The sensors give feedback when
could be attributed to migration of device. The risk of heated and later the matrix is released from the tip of the
pregnancy can be reduced by strict follow-up. The delivery system. Proximal 12 mm of tube is cannulated.
theoretical risk of interference with IVF pregnancy. The concept is to allow the growth of healthy vascularized
Progressive encapsulation is unlikely to interfere with tissue in the porous matrix. The mean procedure time is
embryo transfer. The risks of hysteroscopy should not be 12 minutes. There was no procedure related adverse event.
forgotten. The major drawback with the device is that first Women are asked to continue contraception for
generation ablative techniques are not possible. 12 weeks. HSG at this point confirms success.
Hysteroscopy complications include cervical laceration The EASE trial (evaluation of Adiana system ) was
with tenaculum forceps. Uterine perforation can be completed in 2005. It was stated, 612 women were treated
encountered with forceful dilatation, false passage; bleeding with an 95% bilateral insertion rate.
can occur if hysteroscope is advanced blindly or forcibly
into the uterine cavity. Infection is rare if necessary Ovion Eclipse
precaution of disinfection is undertaken prior to surgery. This system was designed to negate the shortcoming of
Complication of distention media is of concern in Essure implant, such as endometrial abalative technique and
prolonged hystereoscopic surgeries. In sterilization surgery, potential need of IVF pregnancy (Figs 7A and B). To
fluids containing electrolytes when used are less likely to accommodate this criteria, the device was shortened by
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