Human Reproduction: Bioengineering Aspects of Contraception Applied to the Development of a New Female Contraceptive

Abstract

This paper has two purposes: the first is to describe the basic physiology of human reproduction, with particular emphasis on intervention in the reproductive process for the purpose of contraception; the second is to present a new barrier method of contraception for females which has been developed by Vorhauer Laboratories, Inc.

During the design and development of this non-implantable, vaginal contraceptive sponge (VCS) device, the bioengineering aspects of human sexual intercourse and the esthetics of this activity were basic considerations. As a background for the rationale involved, the physiology of the human male and female reproductive systems, the response of human anatomy during coitus, and the fundamentals of current contraceptive techniques are reviewed. Details of the development process are given to provide insight into the medical-bioengineering interfaces involved, and the clinical evaluation programs establishing the safety and effectiveness of the VCS are also outlined.

The COLLATEX^TM Contraceptive Sponge developed by VLI is a diaphragm like device, molded from a new biomaterial, a hydrophilic polyurethane. The VCS is impregnated with a conventional spermicide, Nonoxynol-9. Because of its compatibility with the vaginal environment, the device is intended for a single 2-day use period, with multiple coital episodes possible during this time. Sexual spontaneity is thus inherent in the method since no preparations are required for contraception, other than insertion of the sponge (which can be done up to two days prior to intercourse). The VCS can be inserted and removed as desired by the user. In certain lesser developed countries where price is an extreme consideration, the product will undoubtedly be washed and reused, although this is not recommended since the spermicide can be depleted by repeated washings. Because of its material compliance, the VCS adapts to anatomical variations which are a function of the user and her daily activities. Currently, one size of the sponge is intended for all users.

Appropriate regulatory compliance filings have been made with the United States FDA, and the VCS is currently undergoing extensive clinical effectiveness evaluations. Once marketing approval has been obtained, the product will be sold as an over-the-counter (OTC) contraceptive. Initial marketing of the product outside the United States is scheduled for late 1980.

“There is no such thing as a problem without a gift for you in its hands. You seek problems because you need their gifts.” Richard Bach, ILLUSIONS