2017-10-12 16:11:03
A Condom-Maker’s Discovery: Size Matters

Condoms get a bad rap for being a bad wrap. Men often complain of discomfort, diminished sensation and poor fit. A recent federal study found only a third of American men use them.

Now, changes by the Food and Drug Administration and industry-standards groups have opened the door to the condom equivalent of bespoke suits. A Boston-based company has begun selling custom-fit condoms in 60 sizes, in combinations of 10 lengths and nine circumferences.

Will the development improve the appeal of condoms, the only birth-control method that protects against most sexually transmitted diseases? Public health experts are unsure.

Many ideas for improving condoms have fizzled, sometimes stymied by the costs of testing required to satisfy the F.D.A., which considers condoms to be medical devices. A competition sponsored by the Bill and Melinda Gates Foundation sought ideas for more pleasurable condoms in 2013 but has not yet brought one to market. While some winners are still pursuing prototypes, others have given up.

As the custom-fit condom company, Global Protection Corp., pressed the F.D.A. and industry standards associations for changes, a key priority was smaller sizes, said the company’s president, Davin Wedel. Until recently, standard condoms had to be at least 6.69 inches long, but studies find the average erect penis is roughly an inch shorter.

“The idea was it had to be long enough to fit most men, and excess length could just be rolled,” said Debby Herbenick, a sexual health expert at Indiana University. She and her colleagues published a study of 1,661 men living throughout the United States that found that 83 percent had penile lengths shorter than standard condoms. The average length was 5.57 inches.

In studies, some men have complained that “condoms tend to slip off,” said Ron Frezieres, a vice president of research and evaluation at Essential Access Health, a nonprofit. And sometimes larger condoms actually felt tight because ”shorter men had a big roll of latex at the base of the penis.”

The custom condoms, marketed under the brand name myONE Perfect Fit, come in lengths of 4.9 to 9.4 inches and circumferences of 3.5 to 5 inches. (Standard condoms are typically 6.7 to 8.3 inches long and 3.9 to 4.5 inches in circumference.) The template that men are given to measure themselves does not include inches or centimeters, instead using randomly ordered letters and numbers. One man might be E99, another Z22.

“If they bought a small condom before and it was still too big, it’s horrible for men to have that experience,” said Mr. Wedel, whose company owns myONE condoms. Within hours of going on sale, he said, customers had ordered condoms in all 60 sizes.

One customer, Shawn Reimund, 34, of Austin, Tex., ordered B17. With standard condoms, “the length was frustrating because you would get a lot of sliding,” he said, and excess latex would be “cutting off your circulation. I compare it to an anaconda wrapping around you.” Also, “sometimes the girth just wasn’t enough.”

Some other condom improvement ideas have been downright perplexing. The Galactic Cap, a polyurethane number that covers only the tip and attaches with medical adhesive, hasn’t been tested nearly enough to try for F.D.A. approval. But Charles Powell, its California inventor, nonetheless sells it for $20, “flying under the F.D.A. radar,” he said.

“If they do come after me, I’m going to move my operation across the border into Mexico,” he said. He contends the Galactic Cap allows more sensation because more skin is uncovered, but admits it won’t necessarily protect against sexually transmitted diseases and has prompted complaints that its Band-Aid-like adhesive makes it “painful coming off.”

Other ideas seemed feasible but stalled for financial reasons. Mark McGlothlin, awarded $100,000 by the Gates Foundation to develop natural-feeling collagen condoms from cow tendon or fish skin, said he lacks $2 million for the necessary clinical trials.

Origami condoms, pleated to allow movement inside, received fanfare and a Gates grant. But efforts to check its status with the inventor were unsuccessful and its website appears defunct.

One Gates winner, Mahua Choudhury, a medical pharmacologist at Texas A&M Health Science Center, said condom companies are considering investing in her stretchy hydrogel condom. Her proposal also claims that embedding an antioxidant in the condom can promote blood flow and muscle relaxation to “stimulate and maintain erection.”

Mr. Frezieres’s organization, which won two Gates grants totaling $1.2 million for a clingy, polyethylene “ultra sheer wrapping condom,” has corporate partners and clinical trial results. Now it is “tweaking the material,” hoping to conduct final testing soon, he said.

The custom-fit company president, Mr. Wedel, 50, got into the condom game as a Tufts University undergraduate, when he and a classmate sold condoms in packages festooned with the university’s mascot, Jumbo the elephant.

AIDS was raging, he said, and “we put a fun slogan and a picture on a condom, and presto, we were changing condoms from something taboo.”

Soon, Mr. Wedel, who considered becoming a professional violinist, informed his mother, a church choir director in Crystal Lake, Ill., that he was going “all in on the condom career.” He co-created a glow-in-the-dark condom, helped open Manhattan’s Condomania store, and won a court battle to sell Pleasure Plus, a condom that balloons near the tip.

Still, “condoms have an enormous image problem,” acknowledged Mr. Wedel, whose company works closely with public health organizations. The new federal study found “condom non-use remained common,” and that nearly 7 percent of women using them said condoms “broke or completely fell off.”

Although custom condoms became available in Europe in 2011, sold by TheyFit, which Global Protection purchased, it took years of pressing the F.D.A. and two standards organizations, ASTM International and ISO, for the devices to reach the United States, Mr. Wedel said.

One hurdle: tests like the “hang-and-squeeze,” during which condoms are filled with water and squeezed to see if they leak, and the “airburst” exam, which checks whether condoms break when inflated. Both evaluations were designed for larger condoms.

“If you make a condom that’s less than half the volume of a standard condom, you’re not going to fill it with as much water, or it’s not long enough to stretch on the mandrel for airburst testing,” he said.

Eventually, the F.D.A. granted clearance for expanded sizes, and last year ASTM International devised new testing methods for a wider range of condoms.

On a Reddit page for men who consider their penises small, reaction to custom condoms was mixed.

One member, RatsSewer — who like other users declined to provide his real name — said non-latex materials “would be way more helpful than custom condoms,” adding “If I want good sex, I don’t use a condom.”

Another, Thrown_away011235, seemed interested, citing “condoms rolling up and slipping off in the past.”

Monkeyfun14 said he had ordered custom condoms, and “while they fit well,” he considered standard cheaper ones sufficient. “It’s not like a pair of shoes or a brassiere that you have to wear all day.”

Yaforgot-my-password ordered them, too, saying regular condoms were too small. (“I know it doesn’t fit this subreddit,” he said pointedly, “but I browse here sometimes.”) The custom ones are “pretty good so far.”

Custom condoms cost 66 cents apiece in regular 24-pack shipments ($1.66 apiece in a single six-pack). Early purchasers were also sent the next larger and smaller sizes for free.

Michael Davis, 21, a college student in Waverly, Fla., said he preferred the M77, the size above the one he first ordered. Standard condom circumferences were “just basically too big,” he said. With custom-fit condoms, he has found “no slippage whatsoever.”

Dr. Herbenick said condom education, along with tips like adding lubricant, are more important than access to 60 sizes. She and colleagues published a study that found custom-fit condoms less likely to break but, for some men, more likely to slip.

Some men might “prefer a condom that they think fits their penis,” she said. “But for the most part, men and their partners are fine with existing condoms.”

Still, Mr. Frezieres said, even without “true benefit,” custom condoms might increase usage, simply by being “confidence boosters.”