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A proposed class action alleges the Penuma penile implant is neither safe nor effective—nor cleared by the FDA—for its advertised purpose of cosmetic penis enlargement.
The 34-page lawsuit says that although defendants International Medical Devices, Menova International and Gesiva Medical have advertised the Penuma product as “FDA-cleared” and safe and effective for healthy men with normal bodies who want a larger penis, the parties do not disclose that the device is cleared by the FDA only for use in the cosmetic correction of soft tissue deformities. The suit also alleges another defendant, Dr. James J. Elist, has performed thousands of Penuma implantation procedures despite the fact that the companies have given reasonable consumers the “false impression” that the device has been determined by the FDA to be safe for cosmetic penile enlargement.
According to the complaint, the implantation of the Penuma device does not result in the touted cosmetic benefits, but instead frequently “causes scarring, resulting in the penis becoming shorter,” and interference with normal penile functions. Moreover, the case alleges the defendants have misrepresented that Penuma implantation is both permanent and reversible, as the procedure, the suit says, often leads to infections and complications that require removal of the device, causing permanent damage to the patient.
“Defendants knew these facts at least by 2015, but nevertheless continued to market Penuma as ‘the first FDA-cleared penile implant for cosmetic enhancement’ and to urge consumers with healthy, normal penises to purchase the Penuma device and procedure to ‘enhance and enlarge the length, girth, and size of your penis,’” the lawsuit alleges, claiming the defendants have “profited substantially from these misrepresentations.”
Per the lawsuit, the Penuma device and implantation procedure typically cost $15,000 to $20,000 each.
According to the complaint, Dr. Elist received a patent on the Penuma device in 2002 and subsequently submitted an application for FDA clearance in 2004, analogizing the device to a silicone implant such as that used for reconstructive surgery of the ear, nose and throat. The lawsuit says that in the initial and all subsequent FDA clearance applications, the defendants specifically limited the intended use of the Penuma device for the “correction of soft-tissue deformities,” such as Peyronie’s disease, congenital micropenis and congenital ventral curvature.
The lawsuit alleges overall that the defendants’ advertising claims are wholly false and backed by no evidence. The case also alleges the defendants have known of the disfiguring complications caused by the Penuma’s design for “at least over half a decade.”
The lawsuit looks to represent all individuals in the United States, including its territories and the District of Columbia, who purchased a Penuma device and implantation procedure from four years prior to the filing of this lawsuit through the date of class certification.
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