番茄社区

The FDA has warned a California company about its inappropriate off-label claims regarding several sexual devices including a "MegaVac" penis pump, an "Ultimate" penis extender, and a "Clitoral Enhancement System."

The agency claimed that the firm , a sexual enhancement device manufacturer founded by a namesake psychologist, violated the law by marketing the penis pump as increasing "length and thickness," the penis extender as reversing "shrinkage," and the female device as increasing "clitoral sensitivity and sensation," among other claims.

In the January 8 , the FDA alleged the firm doesn't have the approvals needed to market the devices in these ways. The agency also pointed to problems with the manufacturing processes used to make the devices.

Erectile dysfunction medicine is a big business even outside of pills like sildenafil (Viagra). In 2023, worldwide market revenue for erectile dysfunction devices -- including penis pumps, penile implants, and shockwave therapy -- was an estimated $1.7 billion, according to by the consulting firm Markets and Markets. The market is projected to grow to $2.7 billion in 2028 as more men develop erectile dysfunction due to diseases like prostate cancer and as new-fangled shockwave therapy becomes more popular.

The FDA regulates medical devices in the U.S., including penis pumps (also known as external vacuum erection devices), and companies must follow rules about their marketing and manufacturing.

In an interview, Sanket Dhruva, MD, MHS, a cardiologist at the University of California San Francisco, said the FDA has classification tiers for a huge variety of medical devices, ranging from simple ones such as stethoscopes, to complex ones such as heart valves and deep brain stimulators.

"If you say you're going to treat disease, you have to be authorized by the FDA through the approval regulatory pathway," said Dhruva, who studies medical device regulation.

In a message to 番茄社区, the Dr. Joel Kaplan company cast shade on the FDA: "They are such a large organization that often paperwork submitted gets lost on their end. To date, all the observations from the FDA have been positively addressed, and we are working with them to track down the records we sent, and following up to ensure they have all the documentation they need to satisfy regulatory requirements."

However, some claims targeted by the FDA remain in company materials and on its website.

• The MegaVac Pump System and Metal Hand Pump System product inserts state, "users report an increase in length and thickness ... or correction of mild penis curvature," and use leads to "bigger, harder erections."
• The company's website states that the Stimulate device "embodies decades of research on red-light therapy to maximize erection quality and size by boosting blood-flow, testosterone, and cellular repair." The site also claims it will "reverse penile atrophy."
• According to the website, the Deep penis extender will "reverse shrinkage due to aging or medical conditions" and will straighten penile curvature due to Peyronie's disease.
• The website also states that the Clitoris Enhancement System "effectively increases clitoral sensitivity and sensations," and touts "heightened arousal: increased blood-flow to the clitoral region triggers arousal and physical desire."

The FDA noted that "the exemption from premarket notification procedures" doesn't apply to these devices because of these claims. This means the devices have to undergo a special approval process in order to be legally sold.

The letter suggested that the agency has been targeting the Dr. Joel Kaplan company for some time. In regard to the Clitoral Enhancement System, the agency called it a "clitoral engorgement device," and noted that "a review of our records reveals that you have not addressed our 2014 warning letter violations."

The FDA said that the claims about the clitoral device and others "indicate that this product will use vacuum pressure to increase blood flow to the clitoral region and stimulate clitoral nerve endings to treat female sexual arousal disorder." This "shows an intent for use in the treatment of disease or other conditions."

The agency also claimed that the company failed to follow proper manufacturing procedures in areas such as quality audits, evaluation of contractors, and handling of customer complaints.

In an interview with 番茄社区, Joel Kaplan, PhD, said he is a clinical psychologist with a degree in engineering. He developed the company and "basically" gave it to his nephew-in-law Shumuel Itshaki and his wife about 8 years ago, he said. The FDA warning letter was addressed to Itshaki and identified him as the firm's chief executive officer.

"I went into the office about a week ago, and they were very upset with the warning letter," Kaplan said. "I know they've spent tens of thousands, even hundreds of thousands, working with FDA compliance companies and FDA. They're feeling very frustrated. Whatever they do, the FDA is in their face and won't leave them alone."

Penis pumps are legitimate and long-standing treatments for erectile dysfunction. According to Augusta Medical Systems, which manufactures the devices, the FDA required prescriptions for the devices prior to 1997, the same year that the first "Austin Powers" movie the fictional secret agent's book titled, "Swedish-Made Penis Enlarger Pumps and Me."

Penis pump users use hand pumps or battery-operated pumps to create a vacuum inside a cylinder that's placed over the penis. The vacuum is supposed to draw blood into the penis and create an erection. The user then places a constriction device at the base of the penis to keep the erection rigid.

The devices can help some men with erectile dysfunction, Ryan Terlecki, MD, a urologist at Wake Forest University School of Medicine in Winston-Salem, North Carolina, told 番茄社区. However, "it's rare that you'll find guys who are highly satisfied and continue using it for a long period of time."

As for the penis extender, Terlecki said similar "traction" devices are used to correct curvature of the penis caused by plaques and scarring in patients with Peyronie's disease. The rely on so-called "penile traction therapy," which essentially stretches the penis.

The company website declares that its penis extender product comes with two extra "growth extension rods" and two "comfort foam head pieces." In a modern touch, there's a "tracking app" included, too.

The website also claims that penises will gain 1-3 inches through the use of the product.

A Men's Health writer tried a similar product and that it worked. While he became "significantly longer," at least temporarily, his girlfriend wasn't enthusiastic.

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