Biomedicine > Jadelle Implants > Insertion and Removal

 
BIOMEDICINE

Jadelle® Implants: Insertion and Removal  

Jadelle contraceptive implants
Jadelle® implant

Should a woman undergo a physical exam before receiving Jadelle? 

It is recommended but not essential that a woman considering Jadelle undergo a medical examination. This may include giving a medical history and having a pelvic exam to ensure that she has no diseases or conditions that would make it unsafe for her to use this method. 

Can Jadelle be inserted at any time? 
To make sure the woman is not pregnant, Jadelle rods should be inserted within seven days after the onset of menstrual bleeding or immediately following an abortion. If Jadelle implants are inserted at any other time in the menstrual cycle, the possibility of a preexisting pregnancy must be ruled out and a nonhormonal contraceptive method (such as condoms, spermicides, or diaphragms) must be used for at least seven days following insertion to avoid pregnancy. If ovulation and conception have already occurred before Jadelle is inserted, pregnancy could occur during the month following insertion. 

How are the rods inserted? 
The rods are inserted under the skin of the inner side of the upper arm in a minor surgical procedure. In some countries, a pre-loaded disposable inserter (developed by Leiras) is available. Elsewhere, the rods are loaded in a reusable hollow needle called a trocar. In either technique, a local anesthetic is injected and the clinician makes a small incision-about 3 mm long-using either the disposable inserter or the trocar. The rods are placed subdermally in the shape of a V opening toward the shoulder. The procedure should take only a few minutes. Often the only pain is associated with the injection of the anesthetic. Usually the incision does not require stitches and is covered with a small adhesive bandage and protective gauze bandage.   

Who performs the insertions? 
The rods should be inserted by health care providers who have received training in the procedure. Generally, any trained physician, nurse, nurse-midwife, or other health care provider can perform the insertion. 

What kind of complications are possible? 
The needle providing the anesthetic may sting briefly. Rarely, women may have reactions to the anesthetic used. When the anesthetic wears off, there may be tenderness as well as discoloration, bruising, and/or swelling in the area of the insertion for a few days after placement. There have also been reports of arm pain, numbness, and tingling following placement. During Jadelle clinical trials, infection at the insertion site occurred in 0.4 percent of women over five years. Attention to aseptic technique and proper insertion and removal of Jadelle rods reduce the possibility of infection. In some women, hyperpigmentation occurs over the implantation site, but this effect is usually reversed following removal. During postmarketing use of Norplant, other cutaneous reactions reported include blistering, ulcerations, and sloughing. There have been reports of nerve injury with Norplant, most commonly associated with deep placement and removal. Expulsion of Norplant implants has been reported, more frequently when implant placement was shallow or too close to the incision or when infection was present. 

How should the insertion site be cared for? 
The insertion site should not be bumped for a few days and the area should be kept dry. Also, the woman should avoid heavy lifting for two to three days after the insertion. The protective gauze bandage should be left in place for three days and the small adhesive bandage should be left on for a day or two longer. Some women have reactions to the adhesive of the bandage. 

Are Jadelle rods visible? 
Since the incision is small, most women do not have a noticeable scar. The rods are usually comfortable and barely visible. When they are visible, the outline of the rods can be seen under the skin and they resemble colorless veins.   

Will the rods move around? 
The rods' location may shift. There have been rare postmarketing reports of movement of Norplant capsules. Most of the movement involved minor changes in the positioning of the implants, but some have involved significant displacement of up to several inches. Some of these reported displacements have been associated with pain and subsequent difficult removal of Norplant. 

Can a woman work after the insertion? 
Yes. She can resume her normal work and domestic activities, as long as she does not bump the site, avoids heavy lifting, and keeps the incision site dry for at least three days. The woman does not have to be concerned if pressure is put on the area during normal activities. After the incision has healed, the skin over the rods can be touched at any time. 

How soon after insertion can a couple have sexual relations? 
This depends on when in her menstrual cycle a woman has the rods inserted. If Jadelle rods are inserted during a woman's menses (to ensure she is not pregnant at the time of insertion), the couple may have sexual relations without a back-up contraceptive method 24 hours after the insertion. If the rods are inserted at any other time during the cycle, the possibility of a preexisiting pregnancy must be ruled out and a nonhormonal contraceptive method should be used for at least seven days following the procedure to avoid pregnancy. If a woman does get pregnant, the rods must be removed. 

When should the woman return to the clinic for a checkup? 
The follow-up schedule depends on the practice of the particular clinic or physician's office in which a woman receives the rods. She may be asked to return for periodic health checkups or to report on her experience with the rods. She should be encouraged to return to the same provider or clinic if she has any health problems that worry her; if she wishes to become pregnant; or if she is moving and needs the address of a clinic that provides Jadelle in her new area. Annual checkups offer an occasion to remind women when to have their rods removed, but are not required. 

How is Jadelle's protection reversed? 
One of the most important characteristics of Jadelle is its reversibility. The contraceptive action stops within two to three days after removal of the rods. The rods are removed during a clinical procedure under a local anesthetic, similar to the insertion process. An alternative form of contraception should be used as soon as the rods are removed, unless the woman desires pregnancy. 

When should Jadelle be removed? 
The rods should be removed at the end of the approved duration of use—either 3 or 5 years depending on where it is being used. The U
. S. Food and Drug Administration approved the implant for use of up 5 years, even though the product is not sold in the U.S. The implant has also been approved in Europe for 5 years' use.  

However, the woman should be able to request and obtain removal of the rods at any time, for any reason. 

What happens if the rods are not removed after the approved period of use?
Data have shown that women are protected for up to five years. If the rods are not removed at five years, the risks of pregnancy and of ectopic pregnancy increase. 

Who should remove the rods? 
Health care providers experienced in removals should perform the procedure. The rods can be removed at the same clinic or office where they were inserted or at another health facility that offers the method. Before insertion, a woman should confirm that she will have access to a competent provider at removal time. 

Is removal painful? 
Just as when the capsules are inserted, the health professional will apply a local anesthetic to prevent pain, but the anesthetic injection itself may hurt briefly. If the rods have been inserted properly, removal should be rapid and uncomplicated. When the anesthetic wears off, there may be some tenderness, discoloration, bruising, and swelling in the area for a few days. It is neither necessary nor recommended that general anesthesia be used for this procedure. 

Are removals more difficult than insertions? 
Yes. Although most removals are not difficult, the procedure usually takes longer than insertion. Some rods may be harder than others to locate and remove if they were inserted too deeply or if temporary swelling of the arm occurs during removal. A small incision about 4 mm long will be made, through which both rods are removed. If the clinician is unable to remove both rods during one procedure, the woman should return after her arm heals. Women should be informed of the possibility of needing a subsequent visit for removal and should not be alarmed if this is necessary. Clinicians should feel the insertion site to be sure they can locate both rods before attempting to remove them. If they cannot be felt, the rods can be located through x-ray, ultrasound, or compression mammography, all of which are painless procedures. Removal complications or difficulties were reported in 7.5 percent of more than 1,100 women who had Jadelle removed. Complications (some related to deep placement) included multiple or long incisions, bruising, displacement, pain, prolonged removal, incomplete removal requiring an additional visit or visits, broken implants, and fibrous pericapsular tissue. 

How should a woman care for the site after removal? 
As with insertion, it is important to avoid bumping the removal site for a few days. The area should be kept clean, dry, and bandaged until healed (3 to 5 days) so that the site does not become infected. 

How soon after removal can a woman become pregnant? 
The reversibility of protection afforded by Jadelle is one of the advantages of the method. Once the rods are removed, the contraceptive effect wears off within a few days. 

Can another set of rods be inserted when the old set is removed? 
Yes. If a woman wants to continue using Jadelle, a new set can be inserted when the old set is removed. Or a woman can use Norplant and then switch to Jadelle. The second set can be placed through the incision from which the earlier set was removed or in the other arm. If a woman does not want to continue with the rods and does not want to become pregnant, she should be offered another contraceptive method before she leaves the clinic.  

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This page updated
26 May 2005


 
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