A San Diego doctor landed in the FDA’s crosshairs this month for running a website that makes penis and clitoris pumps that the agency says aren’t properly reviewed.
The federal watchdog agency warned Dr. Barry Kaplan for claims made on his website, where he sells the best penis pump and clitoris enhancement devices along with pills that he calls a "natural Viagra alternative."
Kaplan’s original MegaVac system won 510(k) clearance in 1998 as a device indicated for "external penile rigidity," defined by the FDA as a technology "intended to create or maintain sufficient penile rigidity for sexual intercourse."
Kaplan has since added claims that this vacuum pumps can help resolve erectile dysfunction, add permanent size, increase girth and correct curvature, and other claims that haven’t been cleared by the FDA.
The website also features a "clitoris enhancement system" that the FDA says it hasn’t reviewed at all. The website makes fewer claims for that device, stating only that it’s "designed for women who want to enhance stimulation and/or enlarge their nipples and clitoris."
The FDA ordered Kaplan to act quickly to address the violations or risk further regulatory action, such as seizure, injunction or fines.
