In our continuing coverage of the laser vaginal rejuvenation issues highlighted by FDA in July, we have analyzed letters FDA sent to various companies. In this post, we examine the letter to Thermigen, Inc., a Texas-based company.
The FDA wrote to Thermigen, Inc. on July 24, 2018. The FDA wrote that may the company might be marketing the THERMIva, which meet the definition of a device as that term is defined in section 201(h) of the Federal Food Drug and Cosmetic Act (FD&C Act), in a manner that potentially violates the FD&C Act.
This device was cleared by the FDA via its 510(k) process. The device is a 20-watt electro-thermal radio frequency generator. The generator produces an oscillating electric field in the handpiece and is transmitted to the surrounding soft tissue to heat it.
The FDA’s letter noted that the THERMIva was cleared (K130689-Symphoni RF Generator) for use in dermatological and general surgical procedures for electrocoagulation and hemostasis and to create lesions in nervous tissue when used in combination with Neuro Therm (previously Smith&Nephew) thermal/coagulation probes. We note further that it was cleared to be used in dermatological and general surgical procedures for electrocoagulation and homostastis. Notice that unlike the MonaLisa device we recently covered, there is no mention of gynecology. For this and other reasons, it appears this company could be even more vulnerable to various claims in personal injury/product liability lawsuits where individuals have been injured, as well as other types of litigations, which makes this device of particular interest to the attorneys at KBA.
This device is made by Thermigen, Inc.. From its website we learn, Thermi®, is an Almirall Company, and presents itself as “a leading global manufacturer of temperature controlled radiofrequency technology.” ThermiGen, LLC appears to maintain its website. That same company has a 510(k) clearance for ThermiX Temperature Control Radiofrequency System, Accessories – RF Electrodes. The device at issue here appears to be the only device from this company, Thermigen, Inc., other than the ThermiX Temperature Controlled Radiofrequency (RF) System. In sum, following the corporation relationships and uncovering what each entity knew about the alleged risks and misleading claims will be interesting.
From a potential liability standpoint, in addition to the allegedly deceptive claims, we will be looking at post-marketing warnings failures to uncover safety signals that should have prompted changes in the company’s marketing and promotional activity or design changes. Like the MonaLisa, we did not find any adverse events reported to the FDA in its manufacturer database. This is another one we will continue to investigate for the time being.