GyneFix^®

Background : Uterine Cavities Differ

Studies of the uterus have shown that it is not easy to design a universal IUD.  Indeed uterine cavities differ considerably in all women.  The uterus is also subject to changes in size and volume during the menstrual cycle.  These changes are most pronounced at the time of the menstrual period.  It is therefore unreasonable to expect one standard sized intrauterine device (IUD) to fit uterine cavities of every different sizes and volume.  IUDs that are much bigger, or much smaller than the uterine cavity can cause problems.  If the width of the uterine cavity is too small, side effects and complications are likely to occur.  The crossarms of standard T-shaped IUDs are frequently too long for a large number of uterine cavities, as the average width of most uterine cavities is often smaller than the width of the IUD itself.  When the uterine cavity is much longer than the IUD, the device becomes partly or completely lodged in the lower uterine isthmic segment, triggering uterine activity that may promote explusion and give rise to pain.

Prof. Howard Tatum, inventor of the standard T-shaped IUD:  “The most important factor in reducing IUD side effects is the elimination of distortion of the uterine cavity”
(Verbal presentation at the 4^th Congress of the European Society of Contraception, Barcelona, 12-15 June 1996)

Minimizing the size of the intrauterine foreign body

GyneFix^® standard
(in situ)  

GyneFix^® standard compared with TCu380A (Gravigard^®)  

and Multiload^® (ML) Cu375 IUD.

Three generations of IUDs: GyneFix^® mini is the smallest IUD ever developed

1960s: The Lippes Loop, developed in the 1960s resulted directly from the invention of thermoplastics.

1980s: The TCu380A or Paragard^® seemed a logical design which would cause a minimum of distortion of the endometrial cavity.

2003: The total surface area of the GyneFix^® mini is three times lower than TCu380A and six times lower than the Lippes Loop. The anchored, frameless and flexible, GyneFix^® mini IUD was developed to improve performance and enhance acceptability of intrauterine contraception.
The unique string-shaped GyneFix^® IUD occupies little space in the uterine cavity and is therefore able to fit cavities of every size.

GyneFix^® performance

The following summary is based on large-scale, long term international multicenter randomised and non-randomised comparative studies in parous and nulliparous women covering over 20,000 woman-years of experience:

HIGHLY EFFECTIVE
GyneFix^® is a highly effective IUD.  The use effectiveness of GyneFix® is higher than that found with older generation ‘high-load’ conventional copper IUDs such as TCu380A (See Reviewers’ conclusions: O'Brien PA, Marfleet C. Frameless Versus Classical Intrauterine Device for Contraception. The Cochrane Library, Issue 4, 2001).  The high initial and ongoing effectiveness of the GyneFix^® ‘anchored device’ is attributed to its constant and optimal release of spermicidal copper ions in the upper part of the uterine cavity. Of importance is that ectopic pregnancies almost never occur with GyneFix^®. In this respect, GyneFix^® is superior to the TCu380A (World Health Organisation 10-year follow-up data). Three year multicentre clinical studies with GyneFix^® mini suggest that this small version has a similar efficacy as the standard GyneFix^®.

LOW EXPULSION
When properly inserted, spontaneous expulsion of the GyneFix^® frameless IUD occurs in less than 1% of women during a 5-year period of use.  With older generation ‘framed’ IUDs this incidence has been variously reported, but is on average 5 to 10 times higher, particularly in nulliparous women. As displacement and partial or total expulsion is the main reason for the occurrence of accidental pregnancy, the GyneFix^® is a major step forward in this respect.

OPTIMAL TOLERANCE
As GyneFix^® is ‘frameless’ it is also extremely flexible.  This explains the very low incidence of side effects and complications.  Complaints of pain occur only infrequently with GyneFix^® as its novel design characteristics allow the device to move in harmony with the wearer’s body.
Abnormal bleeding occurs in few women and results from the wearer’s sensitivity to copper.  Medication such as anti-fibrinolytic agents, non-steroid anti-inflammatory drugs have been shown to be helpful in some cases. GyneFix^® mini does not increase blood loss (see below) due to its small size.

Advantages of the "frameless" copper-releasing IUS over conventional "framed" copper IUDs (e.g. TCu380A, MLCu375)

Parous as well as nulliparous women have been highly satisfied with the use of GyneFix^®.

When properly inserted, the frameless IUD offers several important advantages:

• High efficacy

• Efficacy does not decrease with time

• Low expulsion rate

• Reduced bleeding

• Reduced pain complaints

• Long duration of action

Some comments on abnormal bleeding and pain : the main reason for IUD removal

BLEEDING
Increased menstrual blood loss is the main reason for discontinuing the use of IUDs. The magnitude of this increase in menstrual blood loss is related to the size of the device.  With larger types of  non-medicated IUD such as the Lippes Loop, the blood loss is about 70-80 mL, which is  approximately twice that of normal menses.  The amount of excess bleeding is less (50-60 mL) with the smaller copper devices such as the copper T series. Clinical trials demonstrate that particularly the small GyneFix^® version reduces the incidence of heavy blood loss due to the small size of the foreign body. Menstrual blood loss studies suggest that the small GyneFix^® does not increase menstrual blood loss when compared to the period prior to IUD use.
The frameless GyneFix^®, although providing progress in terms of contraceptive performance and patient acceptability, does not itself reduce menstrual bleeding. This can be achieved by delivering intrauterine progestins (Click here for Contrel Research section).

PAIN
GyneFix^® rarely causes complaints of pain due to its small size and flexibility.  With conventional "framed" copper IUDs, incompatibility between the device and the endometrial cavity often causes myometrial distension of the uterus.  Depending on the degree of the disharmony, severe cramping pain can be caused resulting in abnormal bleeding and partial or complete expulsion of the IUD.

Other important features of GyneFix^®

GyneFix^® IN NULLIPAROUS WOMEN  
Fallacies exist about intrauterine devices - most commonly that they can only be used by women who have already had children.  This is not the case with GyneFix^® as it adapts to any uterus, even the smaller uterine cavities of women with no children.
When GyneFix^® has been used in teenagers it has been found to be as effective and acceptable as in older women.
GyneFix^® does not offer protection against sexual transmitted infections (STIs) such as chlamydia, HIV or hepatitis B.  It is therefore not recommended for women likely to have constantly changing sexual relationships, unless used in conjunction with condoms.

GyneFix^® mini should be the preferred option in nulliparous women.

GyneFix^® AS AN EMERGENCY CONTRACEPTIVE
GyneFix^® is particularly useful in emergency contraception because it can be inserted up to 5 days after unprotected intercourse, and will then provide ongoing contraception.  Women requesting emergency contraception tend to be young and have no children.  GyneFix^®  is a good choice for these women, provided they are at low risk of STIs.
IUDs are more effective in preventing unwanted pregnancy than emergency pills.  Pills prevent approximately 3 out of 4 pregnancies, and need to be taken within 72 hours. In contrast hardly any failures have ever been reported when using emergency IUDs.

GyneFix^® FOR IMMEDIATE POST-ABORTAL USE GyneFix^® could constitute an important new option in the prevention of repeat abortion.  In countries like the UK, France and Italy the number of abortions carried out annually is close to 200,000.  This number is much higher in Eastern European and developing countries.  In many countries over 50% of abortions are carried out in women under 25 years old.
Traditional IUDs are more likely to fall out if inserted at the time of a termination of pregnancy.  Their insertion is therefore usually delayed, requiring another visit by the woman and exposing her to a risk of further pregnancy.  However, GyneFix^® with it’s unique secure anchoring system can be fitted immediatly.

GyneFix^® AS AN ALTERNATIVE FOR STERILISATION
In the world today, many women rely on sterilisation of one or other partner to prevent pregnancy. However, many couples would prefer to avoid surgery.  The main drawback of sterilisation is that it is difficult to reverse without futher surgery.  Published figures show that up to 20% of sterilised women in the United States of America request a reversal operation, the results of which are not predictable.
GyneFix^® offers an alternative, long term, effective option.

selected references

journal

title

availability

J Obstet Gynecol Research 2003;29:164-173

The "frameless" copper intrauterine system (IUS) for long-term, reversible contraception - a review of 15 years of clinical experience

 abstract

 full text article

Gynécol Obstét Fertil 2001;29:549-564

L’implant contraceptif intra-uterin sans armature (GyneFix^®) (nouvel inserteur mark 2)

 abstract

 full text article

Menstrual blood loss with a miniature, “frameless”, copper-releasing intrauterine system