Earlier this month, a British man was sentenced to more than four years in prison for rape, after he was convicted of taking off a condom without his partner's knowledge or consent during an otherwise consensual sexual encounter.
Nonconsensual condom removal, otherwise known as "stealthing," has gone from a little-known phenomenon to something that is increasingly catching the eyes of lawmakers, starting with a landmark 2017 legal study that brought the issue to the forefront. A recent study found that 32% of women and 19% of men have been victims of stealthing.
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Already illegal as a form of rape in the UK, as well as Canada, Germany, New Zealand and Switzerland, California became the first U.S. state to codify the act as a civil offense in 2021.
As the laws catch up to what rape and sexual assault survivors and advocates say is a cut-and-dry sex crime, one biotech company is marketing a new kind of birth control as a way for women to protect themselves from stealthing.
The biotech startup Evofem Biosciences is the maker of the contraceptive gel Phexxi, which was given FDA approval in 2020 as a non-hormonal, on-demand birth control option.
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"Stealthing is the most malevolent act. When these men purposefully slip off the condom, it's a criminal act," Saundra Pelletier, the CEO of Evofem, told Newsweek in an interview."
Even if you're not worried about your partner's behavior, if you want to be as empowered as you can, we're suggesting that you use Phexxi regardless."
How Phexxi Works
The gel is the first innovation in birth control brought to market in decades, Pelletier said.
"Since the 1960s when the first birth control pill came to market, pharmaceutical companies have just done rinse and repeat," Pelletier said. "They brought out different ways to deliver hormones: in a pill, in a patch, in an IUD."
Phexxi is non-hormonal, and it does not require the "systemic activity" of having to remember to take a pill at the same time every day. Evofem says the gel is an alternative to women who are breast feeding, cancer survivors, or those whose weight makes the pill a less-effective option.
The medication, which requires a prescription, comes in a pre-filled applicator that Pelletier compared to a tampon. It must be used prior to intercourse, ideally within an hour.
Phexxi uses naturally occurring ingredients like lactic acid, citric acid and potassium bitartrate. The 5-milliliter, odorless and tasteless gel utilizes the science behind a vagina's pH levels. Vaginal pH is typically around 3.5 and 4.5. When semen enters, it raises the vagina's pH to 7 or 8.
"And that's how you get pregnant," Pelletier said.
"Phexxi just helps a woman's body maintain her natural pH...It's very, very easy to use."
Evofem has FDA approval for Phexxi to be used alone as an effective form of birth control. However, Pelletier said it can be used in combination with other forms of contraception, especially if someone forgets to take their pill ever day or just wants an extra layer of protection.
"There's been so much responsibility and burden put on women. We're the ones who have to manage pregnancy. We're the ones who have to protect. It's all on our shoulders," Pelletier said. "You can do what you want, when you want but still be protected."
"It's a win, win and you have the peace of mind that no matter what your partner is doing or not doing, then you are protected," Pelletier said. "Women need choices and they deserve choices."
A Solution to Stealthing
Beyond the potential for unwanted pregnancies, stealthing victims can be exposed sexually transmitted diseases and psychological trauma.
Three years ago, California became the first state to pass legislation against stealthing, allowing victims to sue perpetrators for damages in civil court. Washington state followed suit, passing a bill earlier this year that allows victims of stealthing to seek civil damages.
The Washington law expanded on California's to include other forms of contraceptive tampering like dental dams, spermicides, cervical caps and other barriers meant to deter pregnancy and the spread of disease.
The issue has gained some traction at the federal level through the Stealthing Act of 2022, which was introduced in the House to classify the act as a form of civil sexual battery and empower victims to sue their assailants. But the legislation, along with its partner bill, the Consent Is Key Act, remains in limbo.
That is where Evofem believes Phexxi can play a role. Pelletier said that men who stealth do it because they want power. Beyond stealthing, she noted a study that found half of women have faced "coercive, condom-resistance" from their partners.
"These young men want to have more control," she said. "They think women are becoming more vocal. It's really a power dynamic."
Evofem is pushing Phexxi as a pre-emergency contraception that allows women to be "as spontaneous as men" in their sexuality, according to Pelletier.
"We really are trying to give women the chance to be proactive in every way possible," she said. "Be protective and you have the power to be in charge."
Slow Sales
Both Phexxi and Evofem are not without troubles. The drug's sales have struggled, bringing in just $5 million in the third quarter of last year, according to FiercePharma. The debt-laden Evofem is expected to be acquired by Aditxt, a Virginia-based biotech firm, in a $100 million deal.
Meanwhile, Evofem has been accused by the FDA of overstating the efficacy of Phexxi in a digital brochure that claimed "99% of pregnancies were prevented per act of sex" and that "Phexxi prevented pregnancy 99% of the time."
According to a letter the FDA sent to Evofem, "calculating the pregnancy prevention rate based on 'per act of sex' misleadingly overestimates the effect of Phexxi on pregnancy prevention."
In a statement to Newsweek, Evofem clarified how it determined its "per act of sex" statistic, noting that the Phexxi clinical trial included 1,182 women, with 24,289 acts of intercourse resulting in 101 pregnancies.
"This equates to a pregnancy risk of less than 1% on a per act of intercourse basis – meaning that 99% of pregnancies were prevented. However, because this analysis was not pre-specified in our statistical analysis plan, it is considered post hoc and the FDA will not allow a precedent of allowing post hoc analysis," the company said.
"The most effective from of birth control is the one a woman will use repeatedly and correctly. A pre-emergency, non- systemic and immediate option is an empowering choice for every woman in this time of uncertainty."
Update 6/25/24 2:30 p.m. ET: This story has been updated to correct a misspelling and to clarify that the acquisition of Evofem has not yet closed.
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