One Condoms has begun selling its custom MyOne Perfect Fit Condom, which come in 60 different sizes, following changes in regulations from the FDA and industry standards groups.
Does size matter?
It’s no secret than many people don’t like to use condoms. Common complaints focus on issues related to fit and feel, such as the condom being too loose, tight, short or long. Poor condom fit is a contributing factor to loss of sensation, loss of erection, and difficulty achieving orgasm. In cases where the condom slips off or is removed prematurely, there is an increased risk of unintended pregnancy and sexually transmitted infections (STIs).
Surprisingly, previously available condoms properly fit only 12 percent of men. Here are some examples of the problems that people face with existing condoms:
MyONE Perfect Fit solves these issues by offering a range of 60 condom sizes that will provide a better fit for 9 out of 10 men. These include 28 sizes larger than the leading XL condom and 27 sizes smaller than the average condom—in terms of length, width or both. MyONE lengths range from 4.9 to 9.4 inches, while prior condoms available ranged from 6.7 to 8.3 inches in length. The circumferences available from myONE range from 3.5 to 5.0 inches, while prior condoms available ranged from 3.9 to 4.5 inches.
“After years of dedication and hard work, we are thrilled to announce a condom that will finally address complaints about fit,” said Davin Wedel, president of ONE Condoms. “You might be able to squeeze your large hands into a size-small glove, but that doesn’t mean it will be comfortable to wear. We want the world to know you shouldn’t have to sacrifice comfort for safety when it comes to condoms. Whether big, small or in between, myONE has a condom perfect for you.”
Bringing myONE to market: regulatory and manufacturing challenges
Condoms are classified as Class II medical devices under the Food and Drug Administration (FDA) and conform to safety and testing standards set by the International Organization for Standardization (ISO) and ASTM International. Previously, the only testing standard that existed for new condoms was based on the one-size-fits-all model. This meant that all condoms sold in the United States prior to myONE were required to be at least 6.7 inches long and between 1.9 and 2.2 inches wide in nominal width, which did not accurately reflect the wide range of penis sizes.
Bringing myONE Perfect Fit to the U.S. market has been an ongoing process, spanning over seven years, and has required extensive work among researchers, standards organizations, and ONE’s R&D and manufacturing experts. This effort resulted in updated testing standards and the eventual FDA clearance for myONE Perfect Fit in the United States.
Offering 60 different condom sizes is also a major manufacturing challenge, because it requires the creation of cylindrical glass moulds in all the 60 different sizes. Normally, over 3,000 expensive glass molds are on a production line for each size of condom. Therefore, having 60 different sizes is not only incredibly expensive, but the time to change the lines over is a challenge.
“Although manufacturing myONE is a significant investment and required specialized manufacturing processes and equipment to be developed, we are strongly invested in myONE and its potential to increase condom use overall,” said Davin Wedel.
Public health impact
ONE was founded on the principle of promoting safer sex through condom innovation and design. MyONE is the next evolution in condoms and allows men who have previously not been satisfied with the fit of standard condoms to have a more pleasurable experience.
“MyONE has the potential to change people’s perception of condoms and ultimately, reduce the number of unintended pregnancies and STI occurrences,” says Davin Wedel. “We’re committed to bringing a smart solution to market by offering comfortable condoms at affordable pricing. In fact, we’re giving away 1 million condoms to help men find their fit.”
The effect that myONE may have on public health efforts is particularly important to Wedel, who founded the company in 1987 with a mission to make condoms as socially acceptable as toothpaste in an effort to prevent the transmission of HIV.