The tampon has had the same design for more than 80 years. The creators behind the 'spiral' shape share how change could revolutionize period care.

Amanda Calabrese and Greta Meyer had the idea to create a tampon with a helix-inspired shape in a product design class at Stanford University in 2018. This month, their new Spiral tampon was officially approved by the FDA. This marks the first major change to the tampon's design in more than 90 years.

Now, five years later, what started as a school project has the potential to eliminate period anxiety for people everywhere.

Meyer and Calabrese answer three questions from Yahoo Life about their innovative tampon design and what makes it a game changer in the world of period products.

Calabrese and Meyer were both college athletes — Calabrese was part of the U.S. national lifesaving team and Meyer played collegiate lacrosse — and found in their research as students that many of their peers used tampons and additional period products, such as pads or panty liners, due to fears of leakage, displaying a lack of trust in tampons alone.

“We saw the prevalence of this choice to use a combination of products and that was the main insight that led us to [redesign] the tampon due to premature leakage,” says Calabrese.

Premature leakage, also described by the founders as the “red line effect” and “bypass leakage,” refers to the outflow of menstrual fluid before the tampon has been fully used.

“It’s that phenomenon where you have a leakage event, you remove your tampon and then examine it and you say, ‘Oh my gosh, only 20 to 30% of it is actually absorbed, the rest is white, meaning the fibers have not been in touch with any sort of menses,” says Meyer, adding that this can also lead to “dryness and discomfort.”

Acknowledging this discomfort and leakage anxiety among their peers led them to take a closer look at the current structure of traditional tampons.

Before they could alter the traditional design, they had to figure out why so many tampons on the market seemed prone to leakage before they were full.

They found that most tampons have some linear panels running down the side, giving the fluid a “direct path to the bottom,” says Meyer, explaining that this increases the risk for uneven absorption, which can cause early leakage.

“What was happening was that the vertical panels were funneling the fluid down the side, which can lead to a leakage event,” says Meyer. This then led them to their moment of discovery.

“If we think about basic fluid mechanics, why would we be giving the fluid a very direct path to the bottom?” Meyer asked.

And in looking to change the current state of menstruation products and mitigate some of the anxieties that come with the risk of leakage, Calabrese says they hope to positively change the relationship between tampon users and their period.

“If you distill this [innovation] into two core ideas, it’s the technical side, that these products can leak before they are full, and it's the emotional side, that tampon users deserve peace of mind when they’re menstruating,” says Calabrese.

After figuring out why bypass leakage was so prominent, the two got to work on testing spiral paneling to see if that slowed down the path of fluid, something they found to be a no-brainer.

“Why not give [the menstrual fluid] a walk around the circumference, slow it down, give it longer to be in touch with the tampon and absorb more evenly,” says Meyer.

They were given 10 weeks for the project and worked with a fluid mechanics professor to see if this new flow system would lead to more even absorption, and through a rigorous research and development process, they were able to prove the efficacy of their design.

After receiving positive feedback on their final project and encouragement to pursue their idea beyond the classroom, what was supposed to just be a school project turned into a now FDA-approved medical device that is expected to release in 2024.

While their product is engineered to promote more even absorption compared to what is currently on the market, the actual absorption capacity of the materials of the spiral tampon is in accordance with current FDA regulations. This is an important distinction for the founders who acknowledge the fears many menstruators possess regarding high-absorbency tampons and toxic shock syndrome, or TSS.

"The absorbency is something that's standardized by the FDA so that was a really important design constraint for us," says Meyer.

What is toxic shock syndrome?TSS refers to the rare but potentially life-threatening illness that can occur as a result of certain bacterial infections, particularly staphylococcus aureus, in the case of tampon usage, Dr. Soma Mandal, an internist who specializes in women's health, tells Yahoo Life.

“The vaginal canal is a great place for bacteria to grow. It’s dark. I’s humid, and so when you insert something into it like a tampon, of course, bacteria can grow there,” says Mandal. But what is the link between TSS and high-absorbency tampons?

TSS and absorbent tamponsThe longer a tampon is left in, the greater the risk for bacteria to grow, and since high-absorbency tampons can be left in longer, the risk for infection increases. This, in conjunction with the way tampons were previously manufactured, has contributed to skepticism regarding the safety of high-absorbency tampons for years.

“Back in the 80s, there were these high-absorbency tampons that were also probably not being appropriately used, and so more women were getting toxic shock syndrome, whereas now there's a lot more research going into manufacturing and preventing the bacteria from growing," says Mandal. “There are also a lot more warnings for the public to prevent TSS from happening.”

Tampon safety and SequelThe bottom line is that tampons are a completely safe option when used as intended, says Mandal. The only time she typically recommends forgoing them is for situations when the tampon would be left in for more than eight hours.

“I usually recommend the highest absorbency maxi pad for sleeping, but during the day tampon use is fine,” says Mandal.

And since Sequel's new tampon design meets FDA regulations for absorbency, Mandal describes them as an exciting development in the period space.

“I think a lot of women deal with heavy cycles, which really interferes with their personal and professional lives,” she says. “And so if there is a product that’s safe and can be used so that they’re not worried about getting their clothes stained or dealing with leaks, that is great.”