When Were Female Condoms Invented and What Are the Side Effects?

The female condom, also known as the internal condom, is a barrier contraceptive that offers dual protection by preventing both unintended pregnancy and the transmission of sexually transmitted infections (STIs), including HIV. Unlike methods that alter the body’s chemistry, this device functions purely as a physical barrier. It provides an option for individuals who want control over their contraceptive and infection prevention choices, independent of their partner’s decision to use an external condom.

The Chronology of Female Condom Development

The concept of a receptive condom, worn inside the body, was formalized with the invention of the first generation device (FC1) in 1990 by Danish physician Lasse Hessel. This initial design, constructed from durable, non-latex polyurethane, offered women a barrier method they could initiate and control. The FC1 received clearance from the United States Food and Drug Administration (FDA) in 1993, making it available as a dual protection method.

However, the polyurethane material and complex manufacturing resulted in a high unit cost and user complaints about distracting noise during use. To address these limitations, the second-generation female condom (FC2) was developed, transitioning to a proprietary nitrile polymer.

The FC2 maintains the same basic design but was engineered for a more automated and cost-effective manufacturing process. This material change reduced the crinkling noise and improved user experience. The FDA approved the FC2 in 2009, and it has since become the predominant internal condom available globally, offering the same safety and efficacy as the original at a lower cost.

Mechanism of Protection and Materials

The internal condom functions by creating a physical sheath that lines the vaginal or anal canal, preventing the exchange of bodily fluids and skin-to-skin contact. The device is a loose-fitting pouch with flexible rings at both ends to ensure secure placement. This barrier is composed primarily of nitrile, a synthetic rubber that is strong, flexible, and generally hypoallergenic.

The closed end features an inner ring, which is squeezed for insertion and then sits high inside the vagina, resting against the cervix or pubic bone to anchor the device. The open end has a larger outer ring that remains outside the body, covering the vulva and the entrance to the vagina. This external ring provides a broader area of coverage than an external condom, offering additional protection against STIs transmitted through outer genital skin contact. The nitrile material is pre-lubricated with a silicone-based lubricant and is compatible with both water-based and oil-based lubricants.

Potential Adverse Effects and User Sensitivities

Serious adverse health effects from using the internal condom are exceedingly rare, as the device is non-hormonal and made of inert materials. The most common issues reported are related to physical irritation or user experience, rather than systemic health concerns. Mild physical irritation, such as a burning or itching sensation, can occasionally occur for either partner. This irritation is often a result of friction during intercourse and can be mitigated by applying additional lubricant.

Allergic reactions are minimized because the FC2 is made of nitrile, a non-latex polymer. However, an individual may still have a sensitivity to the nitrile material or to the specific lubricants used on the condom. If a reaction occurs, trying a different brand or ensuring the use of a hypoallergenic lubricant is a recommended first step.

User experience issues can include the device’s appearance, a feeling of slipping, or noise produced during movement. The newer nitrile models have significantly reduced the noise complaint. Slipping is typically due to improper insertion or positioning. In the rare event of a tear or slippage, the risk is pregnancy and STI exposure. The internal condom remains a safe and effective option.

Ensuring Effective Use

Maximizing the effectiveness of the internal condom depends on consistent and correct usage with every act of intercourse. Before insertion, the expiration date on the package must be checked, and the package should be carefully opened to avoid tearing the sheath.

The inner ring is squeezed between the thumb and fingers, and the condom is then inserted into the vagina, similar to a diaphragm or a tampon. The inner ring is pushed up as far as it can comfortably go until it rests against the cervix, ensuring the sheath is not twisted. The larger outer ring must remain outside the body, covering the external genitalia.

It is important to guide the penis into the opening of the condom at the beginning of intercourse and to stop if the penis slips between the condom and the vaginal wall. After intercourse, before standing up, the outer ring should be twisted to prevent semen from spilling out. The condom is then gently pulled out and immediately disposed of in the trash, never flushed, as it is a single-use device.

A major mistake that compromises effectiveness is using the internal condom simultaneously with an external condom, as the friction between the two can cause tearing or slippage. Correct storage in a cool, dry place also helps maintain the integrity of the material.