FDA approves the use of Sequel’s spiral tampon

FDA approves the use of Sequel’s spiral tampon | Image Credit: © Studio KIVI - © Studio KIVI - stock.adobe.com.

The FDA has approved the spiral tampon developed by Sequel as a medical device.¹

Sequel is a startup founded by 2 high-level athletes and Standford engineers, with a goal of improving the standard for women’s products. The approval of their spiral tampon from the FDA provides consumers with a more comfortable option with decreased leakage.

The product features a spiral design which is more fluid mechanically efficient, allowing it to absorb more evenly. This is engineered to prevent leaking before the tampon is full. The FDA approval followed extensive testing of the tampon’s safety and efficacy, the results of which have increased Sequel’s confidence in the design.

Up to 1/3 of menstruating individuals are impacted by heavy menstrual bleeding which negatively impacts their quality of life.² A diagnosis of heavy menstrual bleeding is often based on history taken through menstrual products including pads and tampons.

A recent study evaluated the absorption capacity of alternative products compared to tampons, which are the only absorption product with industry-regulated testing. Products assessed included tampons, pads, menstrual cups and discs, and period underwear. Investigators measured the volume of blood needed for filling or saturation to determine absorption capacity.

The highest capacity of blood cell volume in any product was 80 mL, recorded in a menstrual disc. Under 3 mL have blood were absorbed by the perineal ice-activated cold pack and period underwear separately. Overall, menstrual discs had the greatest capacity with an average absorption of 61 mL, while period underwear had the lowest at 2 mL.

About 20 mL to 50 mL of blood could be absorbed by tampons, pads, and menstrual cups separately. These results showed variability in the blood cell volume capacity of menstrual products, indicating importance for clinicians to ask their patients which product they use.

Investigators concluded understanding new products could help clinicians identify menstrual blood loss and provide treatment. The spiral tampon may be a new option for these clinicians to recommend to their patients, providing improved absorption and comfort.

"Seeing innovation in Womens' healthcare products is always exciting, and the Spiral Tampon holds promise to bring an added quality of life to women who struggle with heavy menstrual bleeding," said Christine Isaacs, MD, professor and vice chair of obstetrics & gynecology at the Virginia Commonwealth University School of Medicine. "Giving women added personal hygiene choices has the potential to be very liberating. Ultimately, consumers will vote with their purchase power, but I am excited to see advancements that may positively affect all women."

Reference

1. Sequel Spiral™ Tampon receives FDA approval as medical device. BusinessWire. August 15, 2023. Accessed August 16, 2023. https://www.businesswire.com/news/home/20230815165783/en/Sequel-Spiral%E2%84%A2-Tampon-Receives-FDA-Approval-as-Medical-Device

2. DeLoughery E, Colwill AC, Edelman A, Samuelson Bannow B. Red blood cell capacity of modern menstrual products: considerations for assessing heavy menstrual bleeding. BMJ Sexual & Reproductive Health. 2023. doi:10.1136/bmjsrh-2023-201895