FDA greenlights spiral tampon breaking 90-year-old design, while research reveals optimal menstrual product type

18 Aug 2023 --- This article unveils the latest innovation and research on menstrual health and hygiene products. Startup Sequel has received approval from US FDA for its tampons designed to better absorb menstrual fluid. Meanwhile, researchers tested the volume capacity of various menstrual products using expired human packed red blood cells.

Heavy menstrual bleeding has a negative impact on up to one third of menstruating individuals’ quality of life, according to researchers at Oregon Health & Science University.

“The diagnosis of heavy menstrual bleeding is based primarily on history taking, which is highly dependent on traditional disposable menstrual products such as pads and tampons,” the authors of the study flag.

The new Seqel tampon is shaped with helical grooves in contrast to the linear channels found on mainstream tampons.“Only tampons undergo industry-regulated testing for absorption capacity. As use of alternative menstrual products is increasing, there is a need to understand how the capacity of these products compare to that of standard products.”

The researchers highlight a need of modernizing understanding of menstrual products and absorption as using saline to test products is not meaningful as it does not reveal how a patient feels or functions with the tampon.

Furthermore, separate research suggests that there is a lack of clarity on diagnosing heavy flows based on the menstrual products used. 

“This lack of clarity may be partly due to lack of industry standardization for absorbency levels. Although labeling of tampon absorbency levels is strictly regulated based on saline absorption capacity, there

is no regulation in pad labeling, resulting in differences among, and even within, brands.”

“Groundbreaking” tampon design 
In new product designs, Sequel’s tampons are shaped with “helical grooves” in contrast to the linear channels found on mainstream tampons. The grooves make the flow path longer and can catch “escaped fluids,” while the liner makes the path shorter, causing risk of leaks.

The approval enables the startup to bring its tampon to market, bringing comfort and better care for women. The brand underscores that the traditional tampon has not changed in 90 years, and is “reinvigorating” a saturated space that has little product differentiation.

“From the beginning, I’ve been impressed with Sequel’s mission to raise the standard of women’s health and wellness, and with this first product, they’ve brought meaningful innovation to a category ready for change,” says Claudia Kotchka, longtime Sequel Advisor and former VP of design, innovation and strategy at Procter & Gamble.

Patent to proprietary manufacturing
Sequel has obtained 11 patents in the US and globally with seven more pending patents.

Seqens highlights that straight flow paths along typical tampons are more prone to leaks than the helical design.“The FDA clearance has been a long process for us, and we know that this is one of the largest barriers to entry for new products in this category,” comments Greta Meyer, co-founder and CEO at Sequel. 

“However, we understand the importance of these devices being held to the highest standards of safety and quality. We are proud of the work our team has done to reach this milestone for Sequel.”

The company shares that it has a proprietary manufacturing method that will enable it to scale up quickly and “transition from proof-of-concept manual manufacturing to automatic manufacturing.” 

The founders Greta Meyer and Amanda Calabrese have formed a manufacturing partnership with Albaad, touted as one of the largest manufacturers of feminine hygiene products and wet wipes. The company plans to start consumer trails of its Sequel Spiral Tampon.

Furthermore, the founders have been featured in this year’s Forbes under 30 list and raised US$5 million in seed funding from Pear VC and MaC Venture Capital.

Menstrual discs top the list
In developments surrounding feminine hygiene research, scientists at Oregon Health & Science University assessed heavy menstrual bleeding and absorbance of menstrual products.

Of the 21 menstrual hygiene products tested, they found that the menstrual disc (Ziggy, Jiangsu, China) held the most blood of any product (80 mL). 

The tampons, pads (heavy/ultra), and menstrual cups held approximately 20 to 50 mL. The most inefficient product was perineal ice-activated cold pack and period underwear, holding less than 3 mL each. 

Meanwhile, researchers working with the American Chemicals Society have analyzed over 100 period products for fluorinated compounds, an indicator of potentially harmful per- and polyfluoroalkyl substances, or PFAS. Their results show that while PFAS are absent from many menstruation products, fluorine was identified in wrappers for numerous pads and some tampons.

They warn that the compounds – which remain in the body for many years when absorbed into the body – might be accidentally or intentionally added to some types of menstruation products by manufacturers.

By Venya Patel