Norplant

As of 1994, there were approximately 47 progestin-containing contraceptive dmg formulations sold in the United States for use as oral contraceptives (Table 3). In addition, there are three nonoral contraceptive formulations containing progestins ie, one injectable (Depo-Provera), one as an intrauterine device (lUD) (Progestasert), and one implantable (Norplant). Of the oral formulations, all but two also contain an estrogen component, ethynylestradiol. 

Implanted Contraceptives. Controlled release of contraceptive progestins also can be accompHshed by incorporating the dmg into an implantable cylinder or rod. The best known implant is Norplant, developed by the Population Council. Norplant is composed of six matchlike silastic cylinders with the progestogen levonorgestrel (11) incorporated on the inside of each cylinder. After implantation under the skin, the product can provide effective contraception for a period of five years (43,44). Since silastic is not biodegradable, the implant can be removed from a patient at any time. 

Clinical studies with Norplant attest to its high contraceptive efficacy and safety. The main reason patients request the removal of Norplant is unpredictable vaginal bleeding episodes followed by amenorrhea. The bleeding problem is an unavoidable sequela of progestogen-only contraception. 

While the effective life of Norplant I is at least five years, most of the users have the implants removed at an earlier time. Norplant II was developed to have a shorter life-span, and is composed of only two rods. Levonorgestrel is dispersed in the silastic matrix which is then inserted into a thin silastic tubing. This product has an effective life-span of two to three years (36). Because it is composed of only two rods, Norplant II also is easier to implant and remove. 

Norplant System. The Norplant System is a long-term system for birth control (see Contraceptives). Investigation of this type of system began ia the eady 1960s, and a patent on the technology was issued ia 1966 (90). 

Implantable controlled release dmg deUvery systems, including Norplant and other contraceptive steroids ia siUcone-based devices, have been reviewed (91,92). 

IMPLANT CONTRACEPTIVE SYSTEM. Levonorgestrel, a progestin, is available as an implant contraceptive system (Norplant System). Six capsules, each containing levonorgestrel, are implanted under local anestiiesia in die subdermal (below the skin) tissues of the mid-portion of die upper arm. The capsules provide contraceptive protection for 5 years but may be removed at any time at die request of the patient. See Table 52-3 for more information on ways to promote an optimal response when taking die contraceptive hormones. 

The first documented use of sUicone as biomaterial was silicone mbber tubing as shunts for treatment of hydrocephalus in about 1955. From 1960 to 1990, the biomedical application of sUicone mbber was steadUy grown. One of the most well-known silicone product is the Norplant contraceptive implant. The first clinical experiment with this device was reported in 1966. FDA approved its use in 1990. 

Norplant is considered very reliable and many women use it voluntarily. Use of Norplant, however, did not remain exclusively voluntary for long. 

Less than one month after Norplant received FDA approval, a California court offered a woman a choice between serving a seven-year sentence for child abuse, or serving only one year and having Norplant implanted while on probation. The woman chose Norplant. 

Legislators in several states have seen Norplant as a way to entice welfare mothers to undergo temporary sterilization. A bill proposed in Mississippi sought to mandate the use of Norplant for female welfare recipients, requiring women with four or more children to be implanted with Norplant in order to qualify for or continue to be eligible for public assistance. ... 

A Kansas Legislator introduced a bill in 1991, that would have paid welfare mothers 500 if they would consent to using Norplant, and an additional 50 for each year that they remained on the contraceptive.After the bill failed, its author proposed a second bill that would make the insertion of Norplant a condition of probation for women convicted of certain drug possession offenses.The bill did not pass. Representative David Duke of Louisiana, (a former leader in the Ku Klux Klan who ran for President of the United States in 1992) unsuccessfully introduced a similar bill in 1991, which would have paid welfare mothers 100 per month if they agreed to Norplant." ... 

Judicial and legislative efforts to impose Norplant in such coercive circumstances raise concerns that similar efforts by judges and legislators may surround the new pharmacotherapy drugs. 

Norplant is a registered trademark of the Population Council, It is manufactured and distributed by Leiras Pharmaceuticals in Finland, under license from the Population Council, It is marketed in the United States by Wyeth-Ayerst Laboratories, Inc, of Philadelphia. 

People V. Johnson, No, 29390 (Cal, Super. Ct., Tulare County 1991), See also, Rees, Matthew, (1991, December 9). Shot in the Arm The Use and Abuse of Norplant, Involuntary Contraception and Public Policy, New Republic, p, 16, The woman later changed her mind, but the Judge refused to reconsider the condition, Cn appeal, the merits of the condition were not discussed because the woman was found to have violated probation by using cocaine. Thus, the Norplant condition was moot on appeal. See, Birth Curb Crder Is Declared Moot, (1992, April 15). New York Times, p, A23... 

S.B. 2895, Miss. (1992). The bill did not pass. See, David S. Coale, Norplant Bonuses and the Unconstitutional Conditions Doctrine, 71 Tex. L. Rev. 189, 195(1992) Alan Guttmacher Institute, Norplant Opportunities and Perils for Low-Income Women (Dec. 1992) (Special Report 1). 

Kan. H.B. 2089,74th Leg., 2d S. (1991), defeated See, Goodman, Ellen. (1991, February 19). Norplant Birth Control-or Woman Control Newsday. 

Kan. H.B. 2255, 74 " Leg., 2dS. (1991), died in committee. See also, Denmark, Stephanie. (1991, October 19). Birth-Control Tyranny. New York Times, p. A23. Patrick, Kerry (1991, March 4). Poor Women and Society Benefit By Linking Norplant, Welfare Aid. Wichita Eagle, p. 11 A. 

Illustratively, all fifty states currently have programs reimbursing poor people for the cost of surgery to implant Norplant. See, Roberts, Dorothy E. (1995). The Only Good Poor Woman Unconstitutional Conditions and Welfare. 72... 

Several progestins are used in combination products. Norgestrel (Ovrette) is a mixture of active and inactive enantiomers levonorgestrel (Norplant) is the active enantiomer. Levonorgestrel and norethindrone are the most potent synthetic progestins in oral contraceptive preparations. 

Mirena is a relatively new intrauterine contraceptive device that releases levonorgestrel into the uterine cavity for 5 years. Use of this contraceptive device is associated with fewer systemic progestin side effects and is at least as effective as Norplant. 

Polymeric membrane-based implantable drug delivery systems have been developed to deliver growth hormone, hormonal contraception, and leuprolide for the treatment of prostate cancer. Implanted sialic tubes loaded with lev-onorgestrel Norplant system) is used outside the United States to provide five years of sufficient sustained release of the... 

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