Penuma Penis Implant Pain and Scarring Class Action

According to the complaint for this class action, Dr. James Elist promotes himself as the “Thomas Edison of penis surgeries,” having invented the Penuma device, a silicone implant designed to enlarge penis size. Elist and the companies associated with the device advertise it as being “FDA-cleared,” the complaint says, but it claims that the device is neither safe nor effective.

The class for this action is all individual in the US, including its territories and the District of Columbia, who bought a Penuma device and implantation, and whose procedures were performed by Dr. James Elist at the Beverly Hills South Pacific Surgery Center, between May 19, 2018 and the date the class is certified in this case.

According to the complaint, medical devices like the Penuma are subject to the Medical Device Amendments of 1976 (MDA) to the Food, Drug and Cosmetic Act (FDCA). In keeping with that, the complaint suggests that the Penuma should have been subject to a rigorous scientific review and premarket approval (PMA) process by the Food and Drug Administration (FDA).

However, the complaint claims that the Penuma did not go through that process, but was grandfathered in: “Manufacturers seeking a less stringent review can thus avoid the FDA’s thorough, scientific PMA process by showing that their devices are ‘substantially equivalent’ to devices that were already on the market in 1976.” Thus, the complaint claims that the device was “FDA-cleared” without the rigorous testing usually required for such devices.

But according to the complaint, the Penuma was cleared only “for use in the cosmetic correction of soft tissue deformities” and not for the enlargement of normal, healthy penises.

The plaintiff in this case, Edward Peña, claims to have had “a normal, healthy penis” with no soft-tissue deformity. In reading the advertising for the Penuma, he says he believed it had been approved by the FDA and was safe for enlarging normal penises. He had the surgery in October 2021.

After the surgery, the complaint alleges, his penis had “no feeling on the top of the shaft and pain on the bottom of the shaft. Two corners of the implant began sticking out…” The complaint alleges he had pain during intercourse and that ‘[t]he implant eventually punctured the skin and poked out through a small hole, through which fluid discharged.” The implant interfered with his sleep, the complaint claims, and gave him painful erections.

Peña eventually had the implant removed, but the complaint alleges he “has continued to suffer complications, including retraction, loss of sensation, and scarring.” The complaint alleges that the implant sometimes even makes penises shorter, because of the scar tissue it causes.

The complaint brings suit against Elist and various related companies associated with the device: International Medical Devices, Inc., Menova International, Inc., Gesiva Medical, LLC, and James J. Elist, MD, a Medical Corporation.

Article Type: Lawsuit
Topic: Medical Devices
Tags: Deceptive Advertising, Defective Medical Devices, Item Does Not Do What It Is Advertised to Do, Medical Devices, Providing False or Misleading Information