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PERMANENT BIRTH CONTROL: NEW METHODS ON THE WAY

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by Barbra Williams Cosentino, R.N., C.S.W.

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Women in 2002 have a growing number of contraceptive options to choose from — old standards like the birth control pill or the diaphragm, and newer methods such as injectable hormone shots or the recently-approved birth control patch.

In spite of the plethora of possibilities, surgical tubal ligation, also known as female sterilization, remains the most widely used form of birth control in the United States, however. According to the Association of Reproductive Health Professionals (ARHP), a multi-disciplinary association of professionals involved with reproductive health care services, education, research and reproductive health policy, 11 million women in this country currently rely on tubal ligation as their way of preventing pregnancy. Nearly

50 percent of women ages 40-44 who use contraception rely on female sterilization, with an estimated 700,000 procedures performed in the U.S. every year. Half of these occur in the immediate postpartum period.

"It is crucial for women to have a range of contraceptive options and to be educated about these choices because this empowers them to take an active role in making decisions about reproductive health care," says Vanessa Cullins, M.D., M.P.H., M.B.A., vice president for medical affairs of Planned Parenthood Federation of America.

Tubal ligations affect only fertility, without a positive or negative effect on libido or hormonal balance. The failure rate extending over 10 years is only 1.8 percent; and the procedure is extremely safe and effective, with extremely low morbidity (complications) and mortality rates. It is, however, intended to be a permanent form of birth control. There has been some success in reversing the procedure should a later pregnancy be desired, but clinicians point out that the rates of ectopic pregnancy (in which the fertilized egg implants itself somewhere other than the uterus) are significantly higher following reversal of surgical sterilization.

 

How It Works Two fallopian tubes, each about three to four inches long, link the uterus and the ovaries and provide an environment where sperm and egg can meet. When the ovary releases an egg, the egg (ovum) is caught by small fingerlike projections called fimbria, and then transported into the tube. If the ovum is fertilized there, it then travels to the uterus where it implants into the uterine lining. Tubal sterilization became increasingly popular during the 1970s, due to a number of medical and socio-economic factors, including:

–development of laparascopic approaches to sterilization which led to shorter operations, shorter hospitals stays, quicker recovery periods, and more acceptable cosmetic results.

– increased safety of anesthesia and surgical procedures.

— controversy about safety of oral contraceptives during this time, which led to a dramatic drop in Pill usage.

— withdrawal of most intrauterine devices (IUDs) from the U.S. market

— insurance coverage for sterilization but not for other forms of contraception.

 

Currently, when a tubal ligation is performed, an abdominal incision is first made, and the fallopian tubes are then sealed either with clips or rings or are cauterized using a quick application of electrical current in the form of heat, so fertilization cannot occur. The procedure, usually performed using either general or regional anesthesia, is usually done in an outpatient surgical facility, and requires several days of recovery.

 

Future Alternatives But, as soon as next year and certainly within the next 10 years, several potential alternatives to tubal ligation are expected to be available. Late last summer at a Manhattan conference (sponsored by the ARHP in conjunction with the Society for Women's Health Research) called "Permanent Birth Control: What's New for U.S. Women?", women's health experts pointed out that researchers are now developing new, less-invasive techniques of permanent birth control which are expected to improve access and safety while also lowering the cost. Rather than requiring an abdominal incision, these new procedures, referred to as transcervical sterilization techniques, allow the clinician to access the tubes by entering the cervix, either through the use of a special instrument with a fiberoptic light source called a hysteroscope, or through blind placement of a device or occlusive material which blocks the tube and prevents conception. These procedures do not require general anesthesia, are typically performed in an office setting, and can be performed on obese women or those with other medical conditions that previously made them poor candidates for conventional tubal sterilization. Transcervical sterilization techniques are most appropriate for women wanting permanent contraception who are over age 30, have a normal uterus and fallopian tubes, and who are willing to use a concurrent contraceptive method if the transcervical method chosen is not immediately effective.

Expected to be available as early as next year, Essure is a micro-insert which, after insertion, expands to block the fallopian tube. The body, recognizing the synthetic device as a foreign object, initiates a benign tissue process. Over the next 12 weeks, there is an overgrowth of tissue spanning the utero-tubal junction which eventually causes occlusion (blocking) of the fallopian tube, explains Jay M. Cooper, M.D., founder and medical director of the Society for Women's Health Research. Patients must use additional contraception for three months until the tissue growth is fully blocking the tube; an X-ray is then taken to insure that the device is in place. Post-procedure recovery is fast, with patients generally leaving the office within 45 minutes after insertion. Dr. Cooper points out that about two-thirds of patients require no pain medication at all and can return to work in one day or less, and clinical trials show a high rate of both effectiveness and patient satisfaction.

Other transcervical methods are in the development stages but are not expected to be available any time soon. One method, transcervical insertion of quinacrine pellets, is somewhat controversial because it was used to sterilize approximately 30,000 women in Vietnam without adequate clinical testing and evaluation. This method also has wide variations in pregnancy rates, and needs further evaluation before phase III clinical trials can begin.

Currently, Family Health International is sponsoring research on the use of the antibiotic Erythromycin as a method of transcervical sterilization. Two other potential methods include a disposable Intratubal Ligation Device (ILD) and the Adiana Procedure, which uses bipolar radiofrequency to create a superficial lesion into which a porous nonbiogradeable implant is then inserted.

"Transcervical sterilization is a revolutionary and highly effective method of permanent birth control which, because of its non-invasiveness and its ability to be performed under local anesthesia, dramatically changes the risk/reward ratio for the patient,” Dr. Cooper says. “We expect this technology to be embraced by both physicians and patients because of the advantages it offers, as compared to more traditional types of female sterilization."

 

 

How often do women regret sterilization? When making the decision to choose sterilization rather than reversible methods of contraception, women must be certain that they are comfortable with the probability of never having any more children. "Making a decision of this magnitude needs to be done carefully and thoughtfully," says Dr. Vanessa Cullins of Planned Parenthood, who points out that although some of these methods can potentially be reversed, or pregnancy might be able to achieved through In Vitro Fertilization (IVF), it is important to consider them as methods which are intended to be permanent.

"To avoid the possibility of post-sterilization regret, adequate counseling is very important for any women making this life-changing decision," says Phyllis Greenberger, M.S.W., president and CEO of the Society for Women's Health Research. Women considering the idea of sterilization need to discuss the present and future ramifications with their partner (if they are involved in a committed relationship) and to explore all the possibilities — would they regret their inability to bear any more children if one of their children died, or if through divorce or death their circumstances changed and they became involved with someone new who wanted to have children? These are painful questions which need to be asked and answered before a decision can be made, Greenberger urges.

The U.S. Collaborative Review of Sterilization (CREST) Study, conducted by the Centers for Disease Control and Prevention, collected data on sterilization procedures performed between 1978 and 1987 at 16 of the nation’s hospitals. To determine the incidence of post-sterilization regret, women were interviewed yearly for the first five years after the procedure was conducted, with one final follow-up interview conducted 8-14 years after sterilization. Patients were asked, "Do you still think tubal sterilization as a permanent method of birth control was a good choice for you?"

Of the more than 7,000 women interviewed annually for up to five years post-procedure, about 6 percent of them expressed regret or sought reversal. Overall CREST findings indicate that the probability of expressing regret within 14 years was 20.3 percent for women age 30 or younger at the time of sterilization, and 5.9 percent for women who were older than 30 when the procedure was done. On the basis of the study results, the majority of women (80 percent) are satisfied with their decision to undergo sterilization. Regret was highest at 14 years for African American women, women whose procedures were performed either postpartum or within one year of the birth of their youngest child, for those who were age 30 or younger, and for those who were unmarried at the time of sterilization.

 


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