GYNE-T® 380 Slimline Intrauterine Copper Contraceptive
Janssen-Ortho
Intrauterine Copper Contraceptive
Intrauterine Contraception
Description: The intrauterine device consists of a polyethylene support in the shape of a “T”. The horizontal arm is 32 mm in length and 1.59 mm in diameter. The vertical arm is 36 mm in length and 1.52 mm in diameter. The vertical arm has at its tip a spherical enlargement, 0.3 mm in diameter. The “T” carries 180 mg of copper wire (265 mm in length and 0.25 mm in diameter) wound around the vertical arm providing a nominal initial copper surface area of 320 mmand one collar with 70 mg of pure copper providing an exposed surface area of 30 mmon the distal portion of each transverse arm. The copper collars are continuous with the horizontal arms of the plastic “T”. The polyethylene support contains 20% barium sulfate to provide x-ray contrast and has high density polyethylene white threads attached to the end of the vertical arm. The insertion tube is equipped with a moveable flange to aid in gauging the depth to which the insertion tube should be inserted through the cervical canal into the uterine cavity. The flange is elongated to allow the plane of the flange to occupy the same plane as the “T” arms. This facilitates insertion by ensuring that the “T” arms, when released, open in the desired direction.
Rationale for the Design: The theoretical advantage of placing the collars on the horizontal arms of the “T” is that the copper supply is brought closer to the fundus of the uterus. Because implantation tends to occur high in the uterus, fundal placement of the copper is considered to enhance effectiveness.
The Gyne-T 380 Slimline device has been designed so that the copper sleeves are continuous with the horizontal arms of the plastic “T”. This facilitates insertion of the device.
Action And Clinical Pharmacology: Available data indicate that the contraceptive effectiveness of the Gyne-T 380 Slimline device is enhanced by a minute quantity of copper being released continuously from the copper coil into the uterine cavity. The exact mechanism by which metallic copper enhances the contraceptive effect of an IUD has not been conclusively demonstrated. Various hypotheses have been advanced, including that copper placed in the uterus interferes with enzymatic or other processes that regulate blastocyst implantation. Animal studies suggest that copper may play a role in reducing sperm transport within the uterine environment. Long-term effects of the release of copper are unknown.
Indications And Clinical Uses: For contraception. A candidate for use of the Gyne-T 380 Slimline device is any gynecologically normal woman of child bearing age who is not pregnant and wishes to minimize the possibility of pregnancy.
Effectiveness: Data are calculated by the life-table method of analysis; pregnancy rates are not expressed by the Pearl formula.
The copper on the horizontal arms of the Gyne-T 380 Slimline device is the same diameter as the plastic “T” and is situated on the distal portion of each transverse arm as compared to the mid-section with the Gyne-T 380 Slimline device (Copper-T Model TCu 380).
The use-effectiveness of the Gyne-T 380 Slimline device is not expected to be significantly different from that seen with the Copper-T Model TCu 380.
In clinical trials conducted in the United States, use-effectiveness of the Copper-T Model TCu 380 as calculated by the Life-Table Method of Analysis was determined. (Rates are expressed as events per hundred women through 12, 24, 36 and 48 months of use.)
This experience is based on 23 126 women months of use, including 679 women who completed 12 months of use, 440 women who completed 2 years of use, 284 women who completed 3 years of use and 153 women who completed 4 years of use.
Relevance of Time of Insertion: Data are available to compare event rates for late postpartum insertion (21 to 90 days postpartum), late post abortion (21 to 90 days post abortion), interval (greater than 90 days postpartum or post abortion) and never pregnant (Sivin and Stern). No significant differences were found in two year pregnancy rates for the TCu 380 as a function of time of insertion, although the TCu 200 gave higher rates when inserted late post abortion or late postpartum. Expulsion rates were moderately higher for the late postpartum and never pregnant insertion of the TCu 380 than for interval insertion. Time of insertion made little difference to removal rates for bleeding and pain, although the lowest rate among TCu 380 users was observed in last post-abortion insertions.
Age: Age at acceptance had appreciable effects on most aspects of performance. Pregnancy rates and expulsion rates among TCu 380 users at two years were highest in the below 20 age group. Removals for bleeding and pain were similar for women less than 20 years and those 20 to 24 years of age at acceptance, but slightly higher than those TCu 380 users 25 years and older.
Reversibility and Return to Fertility: Tatum (1975) has investigated the return of fertility among 420 women terminating the use of the TCu 380 or TCu 220C for the reason of planned pregnancy.
Of those who were followed subsequent to removal, 319 were reported to have conceived. Life table pregnancy rates show that 20.5% had conceived in the first calendar year month subsequent to removal and 78.1% had conceived by the end of the calendar year. There was no difference in conception rates for these 2 devices.
Effect of Time: There is no evidence of decreasing contraceptive efficacy with time before 4 years, but the contraceptive effectiveness at longer times has yet to be established; therefore, the patient should be informed of the known duration of contraceptive efficacy and be advised to return in 30 months for removal and possible reinsertion.
Contra-Indications: Pregnancy or suspicion of pregnancy, anemia, distortion of uterine cavity, acute pelvic inflammatory disease or a history of repeated pelvic inflammatory disease, postpartum endometritis or septic abortion in the past 3 months, previous ectopic pregnancy, endometrial or cervical malignancy, unexplained genital bleeding, acute cervicitis, known or suspected allergy to copper, diagnosed Wilson’s disease, valvular heart disease, leukemia, or use of chronic corticosteroid therapy because of the increased susceptibility to infection with certain microorganisms.
Manufacturers’ Warnings In Clinical States: Pregnancy: Septic Abortion: Reports have indicated an increased incidence of septic abortion, associated in some instances with septicemia, septic shock and death in patients becoming pregnant with one of several types of IUDs in place. Most of these reports have been associated with the mid trimester of pregnancy. In some cases the initial symptoms have been insidious and not easily recognized. If pregnancy should occur with an IUD in situ, the IUD should be removed if the string is visible even though removal may increase the chances of miscarriage. If a decision is made not to remove a device, or removal proves to be difficult, interruption of the pregnancy should be considered and offered as an option. If the patient elects to maintain the pregnancy and the IUD remains in situ, she should be warned that there may be an increased risk of abortion or premature labor and/or sepsis and she should be followed with close vigilance.
Ectopic Pregnancy: A pregnancy which occurs with an IUD in situ is more likely to be ectopic than a pregnancy occurring in the absence of an IUD. Therefore, patients who become pregnant while using an IUD should be carefully evaluated for the possibility of an ectopic pregnancy.
Special attention should be directed to patients with delayed menses, slight metrorrhagia and/or unilateral pelvic pain, and to those patients who wish to interrupt a pregnancy occurring in the presence of the IUD, to determine whether an ectopic pregnancy has occurred.
Continuation of Pregnancy: If the patient chooses to continue the pregnancy and an IUD remains in situ, she must be warned of spontaneous abortion and the increased risk of sepsis, including death. The patient must be closely observed and she must be advised to report immediately all abnormal symptoms, such as a flu-like syndrome, fever, abdominal cramping and pain, bleeding or vaginal discharge, because generalized symptoms of septicemia may be insidious.
Pelvic Infection: An increased risk of pelvic inflammatory disease associated with the use of IUD’s has been reported. This risk appears to be greatest for nulliparous women who have a multiplicity of sexual partners. Salpingitis can result in tubal damage and occlusion, thereby threatening future fertility. Therefore, it is recommended that patients be advised to look for and report symptoms of pelvic inflammatory disease. The decision to use an IUD in a particular case must be made by the physician and patient with the consideration of a possible deleterious effect on future fertility if pelvic infection occurs.
Pelvic infection may occur with an IUD in situ and at times result in the development of tubo-ovarian abscesses or general peritonitis. The symptoms of pelvic infection include: new development of menstrual disorders (prolonged or heavy bleeding), abnormal vaginal discharge, abdominal or pelvic pain, dyspareunia, fever. The symptoms are especially significant if they occur following the first few cycles after insertion. Appropriate aerobic and anaerobic bacteriologic studies should be done and antibiotic therapy initiated promptly. If the infection does not show marked clinical improvement within 24 to 48 hours, the device should be removed and continuing treatment reassessed on the basis of the results of culture and sensitivity tests.
Genital actinomycosis has been associated primarily with long-term IUD use. It has been reported with copper-bearing IUDs as well. Treatment requires prompt removal of the IUD and appropriate antibiotic therapy.
Embedment: Partial penetration or lodging of the IUD in the endometrium or myometrium can increase the difficulty of removal. This may occur more frequently in smaller uteri.
Perforation: Partial or total perforation of the uterine wall or cervix may occur with the use of an IUD, most commonly during IUD insertion. The possibility of perforation must be kept in mind during insertion and at the time of any subsequent examination. If perforation occurs, laparotomy or laparoscopy should be performed as soon as medically feasible and the IUD removed. Abdominal adhesions, intestinal penetration, intestinal obstruction, and local inflammatory reaction with abscess formation and erosion of adjacent viscera may result if the IUD is left in the peritoneal cavity.
Medical Diathermy: The use of medical diathermy (short-wave and microwave) in a patient with a metal-containing IUD may cause heat injury to the surrounding tissue. Therefore, medical diathermy to the abdominal and sacral area should not be used on patients using a copper-bearing IUD.
Effects of Copper: Additional amounts of copper available to the body from a copper IUD may precipitate symptoms in women with undiagnosed Wilson’s disease. The estimated incidence of Wilson’s disease is 1 in 200 000.
The long-term effects of intrauterine copper on the offspring are unknown.
Malonaldehyde (MA) is a normal trace by-product of both prostaglandin biosynthesis and the oxidative breakdown of body fat, and occurs naturally in the human body. MA and related fat breakdown products have been reported to be mutagenic in a variety of test systems, and carcinogenic when applied to the skin of mice at higher than naturally occuring levels. A study (Bond et al) has reported that levels of MA were detected in the cervical mucus of women using copper-bearing IUDs, but not in controls. The author stated that increased levels of MA within the uterus represent an increased risk of carcinogenesis. The concentrations of MA reported to be mutagenic in bacterial or cell culture systems or carcinogenic in mice are higher than the concentration of MA observed in the cervical mucus of women using copper-bearing IUDs.
Precautions: Patient Counselling: Warning: Prior to insertion, the physician must review with the patient the risks and benefits associated with the use of this contraceptive product. The patient should be given the opportunity to discuss fully any questions she may have concerning the Gyne-T 380 Slimline device as well as other methods of contraception and she must be fully warned of the risks associated with each method.
Patient Evaluation and Clinical Considerations: A complete medical history should be obtained to determine conditions that might influence the selection of an IUD as a method of contraception. A physical examination should include a pelvic examination, Pap smear, gonorrhea culture and, if indicated, appropriate tests for other forms of genital disease, including actinomycosis, which can usually be detected on the Pap test.
The uterus should be carefully sounded prior to insertion to determine the degree of patency of the endocervical canal and the internal os, and the direction and depth of the uterine cavity. Care should be exercised to avoid perforation with the sound. Occasionally, severe cervical stenosis may be encountered. Excessive force should not be used to overcome this resistance.
The uterus usually sounds to a depth of 6 to 8 cm. Insertion of an IUD into a uterine cavity measuring less than 6.5 cm by sounding may result in pain, bleeding, partial or complete expulsion, perforation and possibly pregnancy.
To reduce the possibility of insertion in the presence of an existing undetermined pregnancy, the optimal time for insertion is the latter part of the menstrual flow or one or two days thereafter.
It is necessary to place the IUD as high as possible within the uterine cavity to help avoid partial or complete expulsion that could result in pregnancy.
Since the Gyne-T 380 Slimline device represents a unique design in intrauterine contraception, physicians are cautioned that it is imperative for them to become thoroughly familiar with the instructions for insertion before attempting placement of the Gyne-T 380 Slimline device.
IUDs should be used with caution in those patients who have anemia or a history of menorrhagia or hypermenorrhea. Patients experiencing menorrhagia and/or metrorrhagia following IUD insertion may be at risk for the development of anemia. As well, IUDs should be used with caution in patients receiving anticoagulants or in those with a coagulopathy.
Syncope, bradycardia or other neurovascular episodes may occur during insertion or removal of IUDs, especially in patients with a previous disposition to these conditions.
Patients with valvular or congenital heart disease are more prone to develop subacute bacterial endocarditis than patients who do not have valvular or congenital heart disease. Use of an IUD in these patients may represent a potential source of septic emboli.
Use of an IUD in those patients with acute cervicitis should be postponed until proper treatment has cleared up the infection.
Since an IUD may be partially or completely expelled, patients should be re-examined and evaluated shortly after the first post-insertion menses, but definitely within 3 months after insertion. Thereafter, annual examination with appropriate medical and laboratory evaluation and a Pap smear, including examination for actinomycosis organisms, should be carried out. The Gyne-T 380 Slimline device should be replaced every 30 months.
The patient should be told that some bleeding or cramps may occur during the first few weeks after insertion, and that if these symptoms continue or are severe she should report them to her physician. She should be instructed on how to check after each menstrual period to make certain that the thread still protrudes from the cervix and cautioned that there is no contraceptive protection if an IUD has been expelled. She should also be cautioned not to dislodge the IUD by pulling on the thread. If a partial expulsion occurs, removal is indicated and a new IUD may be inserted. The patient should be told to return within 30 months for removal of the IUD and for replacement if desired.
Rarely, a copper-induced urticarial allergic skin reaction may develop in women using a copper-containing IUD. If symptoms of such an allergic response occur, the patient should be instructed to tell the consulting physician that a copper containing device is being used.
An IUD should be removed for the following medical reasons: menorrhagia and/or metrorrhagia producing significant anemia, uncontrolled pelvic infection, genital actinomycosis, intractable pain often aggravated by intercourse, dyspareunia, pregnancy if the thread is visible, endometrial or cervical malignancy, uterine or cervical perforation, or any indication of partial expulsion.
If the retrieval thread cannot be observed, it may have retracted into the uterus, have been broken off, or the IUD may have been expelled. Localization usually may be made by feeling with a probe; if not, x-ray or sonography can be used.
If any patient with an IUD suddenly develops overt clinical hepatitis or abnormal liver function tests, appropriate diagnostic procedures should be initiated.
It has been reported that pregnancy rates in copper IUD users may be considerably higher among diabetics than among non-diabetics. Other reports, however, indicate similar pregnancy rates in the 2 groups.
Requirements for Continuation and Removal: The Gyne-T 380 Slimline device must be replaced before the end of the 30 months of use. The patient should be informed of the known duration of contraceptive efficacy and be advised to return in 30 months for removal and replacement.
An IUD should be removed for the medical reasons referred to in Precautions above.
The usual method for removing the device is by exerting traction on the thread. When this method is used, physicians are advised to exert traction on both strings simultaneously.
Continuing Care of Patients Using IUDs: Since an IUD may be partially or completely expelled, patients should be re-examined and evaluated shortly after the first post-insertion menses, but definitely within 3 months after insertion. Thereafter annual examination with appropriate medical and laboratory evaluation and a Pap smear, including examination for actinomycosis organisms, should be carried out. The Gyne-T 380 Slimline device should be replaced every 30 months.
Adverse Reactions: Perforations of the uterus and cervix may occur. Perforation into the abdomen may be followed by abdominal adhesions, intestinal penetration, intestinal obstruction, local inflammatory reaction with abscess formation and erosion of adjacent viscera. Pregnancy may occur with an IUD in situ or when it has been partially or completely expelled. When conception occurs with intrauterine devices in situ, the incidence of spontaneous abortion, with or without sepsis, appears to be increased over that in unprotected women. Insertion cramping, usually of no more than a few minutes duration, may occur; however, some women may experience residual cramping for several hours or even days. Intermenstrual spotting or bleeding or prolonged or increased menstrual flow may occur.
Pelvic infection including salpingitis with tubal damage or occlusion may occur. This may result in future infertility.
Complete or partial expulsion of the device may sometimes occur, particularly in those patients with uteri measuring less than 6.5 cm by sounding. Urticarial allergic skin reactions may occur.
The following complaints have also been reported with IUD’s: amenorrhea or delayed menses, backaches, cervical erosion, cystic masses in the pelvis, vaginitis, leg pain or soreness, weight loss or gain, nervousness, dyspareunia, cystitis, endometritis, septic abortion, septicemia, leukorrhea, infection of reproductive organs with actinomycosis, ectopic pregnancy, difficult removal, uterine embedment, anemia, pain, neurovascular episodes including bradycardia and syncope associated with insertion or removal, dysmenorrhea, fragmentation of the copper wire on the IUD and breakage of the string.
Dosage And Administration: Device Insertion: The Gyne-T 380 Slimline device is placed in the uterine cavity. The optimal time of insertion is during the latter part of the menstrual period or 1 or 2 days thereafter. The cervical canal is relatively patent at this time and there is little chance that the patient may then be pregnant.
The Gyne-T 380 Slimline device must be removed and a new one inserted within 30 months from the date of insertion.
The physician should become thoroughly familiar with the instructions for insertion before attempting placement of the Gyne-T 380 Slimline device.
Matters to Discuss With Your Patient: (1) What the patient should know about the Gyne-T 380 Slimline IUD.
(2) Use Effectiveness.
(3) Preconditions: (a) What the patient must tell the physician. (b) Adverse reactions. (c) Contraindications.
(4) Post-Insertion Instructions: (a) Ongoing care of the IUD. (b) Side effects. (c) Warnings and need for follow-up: severe or prolonged bleeding; pelvic pain and cramps; venereal disease; allergic reactions-rash; no medical diathermy; pregnancy and IUD; removal; change every 30 months.
This list is to assist the physician in providing information and warning to the patient. Although this list is provided as a matter of convenience, the physician must familiarize himself/herself thoroughly with the detailed information and warnings relating to this product set out in the enclosed prescribing brochure.
Instructions for Insertion: The Gyne-T 380 Slimline Intrauterine Copper Contraceptive represents a unique design in intrauterine contraceptives. Physicians are therefore cautioned that they should become thoroughly familiar with instructions for insertion before attempting placement of the Gyne-T 380 Slimline device. The insertion technique is different in several respects from that employed with other intrauterine contraceptives currently available, and the physician should pay particular attention to the drawings and commentary accompanying these instructions.
Pre-Insertion: It is essential that sterile technique be utilized throughout the insertion procedure. Take a medical history and perform a thorough pelvic examination to determine freedom from overt disease and to determine position and shape of the uterus. Rule out pregnancy and other contraindications. Appropriate microbiological tests including, gonorrhea cultures, should be taken. The endocervix should be cleansed with an antiseptic solution. With a speculum in place, gently insert a sterile sound to determine the depth and direction of the uterine cavity. Be sure to determine the position of the uterus before insertion. The use of a tenaculum to straighten the uterine canal prior to sounding and insertion is recommended. The Gyne-T 380 Slimline device should preferably be inserted during or shortly after menstruation to ensure a non-pregnant state. (This approach may not be practical in certain clinical situations.)
Insertion: Caution: It is generally believed that most perforations occur at the time of insertion, although the perforation may not be detected until some time later. The position of the uterus should be determined during the pre-insertion examination. Great care must be exercised during the pre-insertion sounding and subsequent insertion. No attempt should be made to force the insertion.
How to Insert (see package insert for illustrations):
Step 1: To minimize the chance of introducing contamination, do not remove the “T” from the insertion tube prior to placement in the uterus. Do not bend the arms of the “T” earlier than 5 minutes before it is to be introduced into the uterus.
Using the Loading Capsule: Place package on a flat surface with the “clear” side of the package facing upward. Peel back the top layer completely and detach the loading capsule from the insertion tube.
Push the insertion tube against the loading capsule to fold the arms of the “T”.
Continue to push until the arms of the “T” are fully enclosed in the narrow end of the loading capsule.
Withdraw the insertion tube slightly until clear of the arms of the “T”.
Reinsert the insertion tube while squeezing the flexible walls of the loading capsule to place the arms of the “T” inside the walls of the insertion tube. Insert no further than necessary to ensure retention of the arms.
Twist a quarter turn to disengage the “T” and the insertion from the capsule. The “T” is now ready for insertion.
Step 2: Adjust the moveable flange so that it indicates the depth to which the Gyne-T 380 Slimline device should be inserted and the direction in which the arms of the “T” will open. At this point, make certain that the horizontal arms of “T” and the long axis of the flange lie in the same horizontal plane. Introduce the loaded inserter through the cervical canal into the uterine cavity (do not take out until the “T” lies in contact with the fundus). The moveable flange should be at the cervix. Do not force the insertion.
Step 3: To release the Gyne-T 380 Slimline device from the insertion tube, hold the solid rod stationary and retract the insertion tube. This withdrawal method releases the arms of the “T” without further upward movement of the “T”.
Step 4: After the arms are released, the inserter tube should be gently moved upward until the resistance of the fundus is reached. This will assure placement of the “T” at the highest possible position within the endometrial cavity.
Step 5: Withdraw the solid rod while holding the insertion tube stationary.
Step 6: Withdraw the insertion tube from the cervical os until the strings are visible. Be sure sufficient length of string is visible to facilitate checking for its presence.
Availability And Storage: The Gyne-T 380 Slimline Intrauterine Copper Contraceptive is packaged in individual sterile package units plus insertion tube, solid rod and loading capsule. Boxes of 10 and 50.
GYNE-T® 380 Slimline Intrauterine Copper Contraceptive Janssen-Ortho Intrauterine Copper Contraceptive Intrauterine Contraception Description: The intrauterine device consists of a polyethylene support in the shape of a “T”. The horizontal arm is 32 mm in length and 1.59 mm in diameter. The vertical arm is 36 mm in length and 1.52 mm in diameter. The vertical arm has at its tip a spherical enlargement, 0.3 mm in diameter. The “T” carries 180 mg of copper wire (265 mm in length and 0.25 mm in diameter) wound around the vertical arm providing a nominal initial copper surface area of 320 mmand one collar with 70 mg of pure copper providing an exposed surface area of 30 mmon the distal portion of each transverse arm. The copper collars are continuous with the horizontal arms of the plastic “T”. The polyethylene support contains 20% barium sulfate to provide x-ray contrast and has high density polyethylene white threads attached to the end of the vertical arm. The insertion tube is equipped with a moveable flange to aid in gauging the depth to which the insertion tube should be inserted through the cervical canal into the uterine cavity. The flange is elongated to allow the plane of the flange to occupy the same plane as the “T” arms. This facilitates insertion by ensuring that the “T” arms, when released, open in the desired direction. Rationale for the Design: The theoretical advantage of placing the collars on the horizontal arms of the “T” is that the copper supply is brought closer to the fundus of the uterus. Because implantation tends to occur high in the uterus, fundal placement of the copper is considered to enhance effectiveness. The Gyne-T 380 Slimline device has been designed so that the copper sleeves are continuous with the horizontal arms of the plastic “T”. This facilitates insertion of the device.
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