Praxis Dr. med. Erik-C. Miller
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Intrauterine
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Copper
IUD
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Progesterone IUD
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The
intrauterine
device (IUD) is the world's
most widely used method of
reversible birth control for women and already
indicated 1909
by Richter, but actually introduced only by
Graefenberg.
The coil has a PEARL
-Index less than 0.5. However the principle of this
contraceptive is very old. The Bedouins
put stones in
the uterus of camels to prevent pregnancies of the animals during cross
the desert.
picture 1
Today in Germany two types of IUD are used mostly, Multiload (left) and Copper-T:
Since 1998 worldwide, several new intrauterine devices (IUDs) are under development or in the early marketing phase.
These new devices contain various modifications designed to improve patient continuation and physician satisfaction. Modifications include those designed to facilitate easier insertion and removal, decrease the rates of accidental expulsion, and reduce complaints of pain or bleeding (responsible for 30% to 50% of discontinuations).
Developers are designing devices to address these issues by modifying IUD size, shape, and flexibility. At least six new devices are under development, or have recently been introduced, outside the US. These devices include: the CuSafe 300, Fincoid-350, Sof-T and the Multiload Mark II, FlexiGard 330® (recently introduced in Europe as the GyneFix®), intracervical fixing device (ICFD):
picture 2
CuSafe 300
The CuSafe 300 is a T-shaped copper IUD with flexible, uniquely shaped arms. Both ends of the device's transverse arms curve inward to reduce uterine tissue irritation. In addition, its mono filament tail is welded into the shaft, instead of knotted, to reduce ectocervical abrasion. According to its German developer, not only does the device's flexible design facilitate easier and less painful insertion and removal, but the curved, "fundal-seeking" arms also resist expulsion.
CuSafe insertion requires neither plunger nor sterile gloves. Furthermore, with a diameter of 3.0 mm, the inserter is about one third smaller than that of the copper T 380A IUD. These improvements should make the CuSafe easy to insert and remove. The CuSafe, approved in Europe in April 1996, carries a recommended life span of 5 years.
In one study comparing CuSafe and TCu380A IUDs, removals for pain and bleeding occurred significantly less frequently among CuSafe IUD users. On the other hand, the study found that the CuSafe had higher, although statistically non significant, rates of pregnancy and expulsion. Another study of 1,150 women (analyzing about 10,000 women months of use) found pregnancy and expulsion rates of 0.6 per 100 women at 1 year of use. The 1 year continuation rate was 89%.
Fincoid-350
The Fincoid-350, devised in Finland, is also designed to resist accidental expulsion. The IUD has a plastic skeleton comprised of two parts: curved horizontal arms, and a copper coated vertical stem. The horizontal arms lock into a groove on the vertical stem. The resultant movable joint easily constricts and expands with uterine contractions, adjusting to variations in uterine size and shape. The Fincoid-350 comes in two sizes: standard and short.
Studies indicate continuation rates of 90% for the Fincoid-350 device. A study of 792 women found a pregnancy rate of 0.6%, an expulsion rate of 3.7%, and a rate of removals for pain or bleeding of 2.6%. Another study of 90 women found a higher failure rate of 2.8%.
Sof-T
The Sof-T, manufactured and approved for use only in Switzerland, is a copper IUD with a unique shape to enhance effectiveness. The device has soft, flexible knobs, or occlusion bodies, on each end of its flexible transverse arms. These knobs theoretically block the entrances into the fallopian tubes.
The insertion procedure for the Sof-T is similar to that of currently available copper IUDs. Two dimensional ultrasound must be used, however, to ensure exact placement of the device. The device's potential ability to occlude the fallopian tubes could, in theory, reduce the incidence of tubal infection and ectopic pregnancy; however, comparative trials have yet to be performed. On the other hand, the knobs may incompletely block the fallopian tubes and result in higher rates of ectopic pregnancy.
About 1,200 women currently wear the device. Limited data indicate that the annual expulsion rate ranges between 0.3% and 3.5%, removals for pain or bleeding range from 0% to 1.4%, and the Pearl index failure rate ranges from 0% to 1.3%.
Multiload Mark II
The Multiload Mark II is an updated version of the original Multiload 375 (ML 375). The original device has a record of dependability, with low patient cessation rates due to pregnancy, expulsion or bleeding and pain. The ML 375 has been associated with problematic insertions, however, because its arms do not fit into the inserter; the arms are open during insertion, making placement more difficult.
Developers hope the Multiload Mark II will overcome these insertion limitations. Like its prototype, the Multiload Mark II has a 375 mm² copper coated shaft; however, it has shorter, more flexible arms that allow the device to be folded completely into its inserter. As a result, the new inserter's diameter is smaller than the original model. In addition, the inserter has three other improvements: its design prevents the IUD from getting pushed beyond the inserter; it can function as a uterine sound; and it has a one handed expulsion action. These innovations may help limit the risk of uterine perforation. The Multiload Mark II was developed in The Netherlands. Few data are currently available on the device's effectiveness or its effect upon ease of insertion.
GyneFix®
The GyneFix, a "frame less" IUD, consists of six 5 mm copper sleeves thread onto a length of semi rigid suture material. This device was originally called the Cu-Fix 390, then later the FlexiGard 330®. The device has undergone 10 years of testing and several modifications to its inserter and anchoring mechanisms. The upper and lower copper sleeves are crimped onto the suture thread to prevent slippage. The proximal end of the suture contains a knot that is pierced 1 cm into the fundal myometrium to anchor the device into the uterine muscle. Variations of the device for postpartum use include a larger knot and a cone shaped biodegradable tip that help anchor it securely.
Due to its frame less design, flexibility, and minimal presence in the uterine cavity, the GyneFix is associated with few expulsions. In addition, the device has a high continuation rate at 1 year (90%) due to few removals for complaints of bleeding or pain.
Effectiveness depends upon proper insertion technique because the device must be securely anchored into the uterine myometrium or it will be expelled. Reports indicate that clinicians can easily learn the new insertion technique. The reported failure rate from long term clinical studies is 0.5 at 3 years, which is as low, or lower than the copper T 380A. In addition, the device has very low expulsion rates among nulliparous women.
Intracervical Fixing Device (ICFD)
The intracervical fixing device differs substantially in both construction and placement from other IUDs. The device consists of a rod shaped, copper coated polyethylene frame that is about 4 cm long with a 5 mm projection at the distal end. Through this projection, the ICFD is anchored (fixed) to the inner cervical wall using a modified tenaculum. Removal is facilitated by grasping the stem with sponge forceps.
A feasibility study of the device in 11 women identified difficulty in disengaging the modified tenaculum from the device. Investigators believe the ICFD's anchoring mechanism could be improved, however, and new fixing techniques are being studied in Belgium. Better anchoring mechanisms could help to prevent expulsions. One potential advantage of the device is that the insertion procedure is not blind. In addition, because of the intracervical location, the device will likely be associated with less spotting, bleeding and pain.
Conclusion
Developers are designing new IUDs with modifications to help enhance patient and physician acceptance. Modifications to the devices aim to decrease removals for pain and bleeding, make insertion and removal easier, and limit the risk of expulsion. Although a few of these IUDs are available in Europe, it is unclear if, and when, they might be marketed in the United States.
 |
a.
Lippes-Loop b. Saf-T-Coil c. Dana-Super Dana cuprum d. Copper-T (Gyne-T) e. Copper-7 (Gravigard) f. Multiload g. Progesterone IUD |
Today in Germany two types of IUD are used mostly, Multiload (left) and Copper-T:
Since 1998 worldwide, several new intrauterine devices (IUDs) are under development or in the early marketing phase.
These new devices contain various modifications designed to improve patient continuation and physician satisfaction. Modifications include those designed to facilitate easier insertion and removal, decrease the rates of accidental expulsion, and reduce complaints of pain or bleeding (responsible for 30% to 50% of discontinuations).
Developers are designing devices to address these issues by modifying IUD size, shape, and flexibility. At least six new devices are under development, or have recently been introduced, outside the US. These devices include: the CuSafe 300, Fincoid-350, Sof-T and the Multiload Mark II, FlexiGard 330® (recently introduced in Europe as the GyneFix®), intracervical fixing device (ICFD):
 |
 |
 |
 |
 |
 |
| Cu
Safe 300 |
Fincoid-350 |
Sof-T |
Multiload
Mark II |
GyneFix |
ICFD |
CuSafe 300
The CuSafe 300 is a T-shaped copper IUD with flexible, uniquely shaped arms. Both ends of the device's transverse arms curve inward to reduce uterine tissue irritation. In addition, its mono filament tail is welded into the shaft, instead of knotted, to reduce ectocervical abrasion. According to its German developer, not only does the device's flexible design facilitate easier and less painful insertion and removal, but the curved, "fundal-seeking" arms also resist expulsion.
CuSafe insertion requires neither plunger nor sterile gloves. Furthermore, with a diameter of 3.0 mm, the inserter is about one third smaller than that of the copper T 380A IUD. These improvements should make the CuSafe easy to insert and remove. The CuSafe, approved in Europe in April 1996, carries a recommended life span of 5 years.
In one study comparing CuSafe and TCu380A IUDs, removals for pain and bleeding occurred significantly less frequently among CuSafe IUD users. On the other hand, the study found that the CuSafe had higher, although statistically non significant, rates of pregnancy and expulsion. Another study of 1,150 women (analyzing about 10,000 women months of use) found pregnancy and expulsion rates of 0.6 per 100 women at 1 year of use. The 1 year continuation rate was 89%.
Fincoid-350
The Fincoid-350, devised in Finland, is also designed to resist accidental expulsion. The IUD has a plastic skeleton comprised of two parts: curved horizontal arms, and a copper coated vertical stem. The horizontal arms lock into a groove on the vertical stem. The resultant movable joint easily constricts and expands with uterine contractions, adjusting to variations in uterine size and shape. The Fincoid-350 comes in two sizes: standard and short.
Studies indicate continuation rates of 90% for the Fincoid-350 device. A study of 792 women found a pregnancy rate of 0.6%, an expulsion rate of 3.7%, and a rate of removals for pain or bleeding of 2.6%. Another study of 90 women found a higher failure rate of 2.8%.
Sof-T
The Sof-T, manufactured and approved for use only in Switzerland, is a copper IUD with a unique shape to enhance effectiveness. The device has soft, flexible knobs, or occlusion bodies, on each end of its flexible transverse arms. These knobs theoretically block the entrances into the fallopian tubes.
The insertion procedure for the Sof-T is similar to that of currently available copper IUDs. Two dimensional ultrasound must be used, however, to ensure exact placement of the device. The device's potential ability to occlude the fallopian tubes could, in theory, reduce the incidence of tubal infection and ectopic pregnancy; however, comparative trials have yet to be performed. On the other hand, the knobs may incompletely block the fallopian tubes and result in higher rates of ectopic pregnancy.
About 1,200 women currently wear the device. Limited data indicate that the annual expulsion rate ranges between 0.3% and 3.5%, removals for pain or bleeding range from 0% to 1.4%, and the Pearl index failure rate ranges from 0% to 1.3%.
Multiload Mark II
The Multiload Mark II is an updated version of the original Multiload 375 (ML 375). The original device has a record of dependability, with low patient cessation rates due to pregnancy, expulsion or bleeding and pain. The ML 375 has been associated with problematic insertions, however, because its arms do not fit into the inserter; the arms are open during insertion, making placement more difficult.
Developers hope the Multiload Mark II will overcome these insertion limitations. Like its prototype, the Multiload Mark II has a 375 mm² copper coated shaft; however, it has shorter, more flexible arms that allow the device to be folded completely into its inserter. As a result, the new inserter's diameter is smaller than the original model. In addition, the inserter has three other improvements: its design prevents the IUD from getting pushed beyond the inserter; it can function as a uterine sound; and it has a one handed expulsion action. These innovations may help limit the risk of uterine perforation. The Multiload Mark II was developed in The Netherlands. Few data are currently available on the device's effectiveness or its effect upon ease of insertion.
GyneFix®
The GyneFix, a "frame less" IUD, consists of six 5 mm copper sleeves thread onto a length of semi rigid suture material. This device was originally called the Cu-Fix 390, then later the FlexiGard 330®. The device has undergone 10 years of testing and several modifications to its inserter and anchoring mechanisms. The upper and lower copper sleeves are crimped onto the suture thread to prevent slippage. The proximal end of the suture contains a knot that is pierced 1 cm into the fundal myometrium to anchor the device into the uterine muscle. Variations of the device for postpartum use include a larger knot and a cone shaped biodegradable tip that help anchor it securely.
Due to its frame less design, flexibility, and minimal presence in the uterine cavity, the GyneFix is associated with few expulsions. In addition, the device has a high continuation rate at 1 year (90%) due to few removals for complaints of bleeding or pain.
Effectiveness depends upon proper insertion technique because the device must be securely anchored into the uterine myometrium or it will be expelled. Reports indicate that clinicians can easily learn the new insertion technique. The reported failure rate from long term clinical studies is 0.5 at 3 years, which is as low, or lower than the copper T 380A. In addition, the device has very low expulsion rates among nulliparous women.
Intracervical Fixing Device (ICFD)
The intracervical fixing device differs substantially in both construction and placement from other IUDs. The device consists of a rod shaped, copper coated polyethylene frame that is about 4 cm long with a 5 mm projection at the distal end. Through this projection, the ICFD is anchored (fixed) to the inner cervical wall using a modified tenaculum. Removal is facilitated by grasping the stem with sponge forceps.
A feasibility study of the device in 11 women identified difficulty in disengaging the modified tenaculum from the device. Investigators believe the ICFD's anchoring mechanism could be improved, however, and new fixing techniques are being studied in Belgium. Better anchoring mechanisms could help to prevent expulsions. One potential advantage of the device is that the insertion procedure is not blind. In addition, because of the intracervical location, the device will likely be associated with less spotting, bleeding and pain.
Conclusion
Developers are designing new IUDs with modifications to help enhance patient and physician acceptance. Modifications to the devices aim to decrease removals for pain and bleeding, make insertion and removal easier, and limit the risk of expulsion. Although a few of these IUDs are available in Europe, it is unclear if, and when, they might be marketed in the United States.
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