We have reported on the FDA’s recent statements regarding devices used for “vaginal rejuvenation” when the Food And Drug Administration first issued its warning and more recently. Cynosure, Inc., a Hologic Company, posted a letter to its customers on August 2, 2018. It raises several important issues.
Within the letter on its website, the company noted that FDA questioned some of the claims on its website; specifically, whether its FDA 510(k) clearances included those claims. Specifically, FDA wrote to Cynosure, Inc. in Massachusetts and identified the following claims that might be beyond the scope of FDA’s clearance:
• “MonaLisa Touch is the only technology for vaginal and vulvar health with over 18+ published clinical studies.”
• “MonaLisa Touch is a simple, safe, and clinically proven laser treatment for the painful symptoms of menopause, including intimacy.”
• ‘During a treatment, a vaginal probe is inserted into the patient’s vagina, and delivers gentle, virtually painless laser energy to the vaginal wall, stimulating a healing response.”
• “It penetrates the wall of the vagina, and stimulates cells that are important in creating fluid, improving collagen synthesis.”
• “Fibroblasts activate biosynthesis of new collagen and produce main components of ground substance.”
This relates to a point we recently raised about off-label marketing in our last post about this topic. However, it reminds us of the broad range of misconduct that may be at issue here.
The Commissioner’s statements were broad and not company specific. Some followers of this issue have had the impression that the devices were not cleared or approved for any related use, which would present several serious legal issues. This particular company, and it is but one among others, is forecasting that in some cases, the regulatory issues may be murkier.
The company’s “MonaLisa Touch” device is called the DEKA SMARTXIDE2 Laser System. The device is a laser that delivers energy to the treatment area when operated by a footswitch. It has a wavelength of 10600 nm and a 60 Watt max power.
The FDA cleared it via the 510(k) process on September 5, 2014, a mere month after it was received by FDA.
It was cleared for the following indications for use: “It is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.” Based on the company’s letter and this language, it would appear the company will argue it had a broad clearance from FDA that included the uses at issue and claims it made.
The attorneys at KBA have been down this road before. In a prior medical device litigation KBA Attorneys fought for several years, the device companies made similar general vs. specific indication for use arguments. Our ability to achieve significant recovery for our clients turned in part on our ability to navigate these FDA issues by working with prominent industry experts that we developed. So we’ll be keeping a close eye on this one for a bit.
One of the directions this could take is looking at the companies’ failure to test the device adequately. The device was cleared without any nonclinical performance data or any clinical performance data. There was one animal study noted in the 510(k) summary, “Animal study on sheep’s skin was conducted to show the comparative effects of Smartxide laser and Affinity lasers on thermal lesion depth and width as well as ablation depth and width.” Failure to test allegations are a controversial topic in the mass tort legal community as between plaintiffs’ and defense lawyers, but the concept is a pretty well-enshrined approach to these cases if presented in accordance with the existing case law from around the country.
Of course, post-market surveillance will be at the center of our investigation of this potential medical device litigation because that is how medical device companies can prevent injuries and keep patients safe. Our preliminary research has not uncovered any adverse events reported to the FDA, which could mean the company is unaware of them, or, as happens all too often, the company is not reporting them as it should be.
On another note, the Food And Drug Administration also raised the issue of a modification to the device that may not have been cleared. The company did not see to address this in its letter. The FDA wrote, “The tip of the sterilized applicator that is inserted through the vulva and moved along the vaginal canal in an outward motion, applying the laser in a 360-degree pattern to the vaginal wall, appears to have been modified from the previous cleared device.”
This may be a regulatory infraction that the company has to deal with and unrelated to complaints from women of pain during sex and other issues, but it is interesting nonetheless, if for no other reason than it suggests the company may not be following the FDA law and regulations as closely as it should. In our experience, that is usually indicative of post-market failures as well.
The attorneys at KBA will continue to follow this developing story closly, and continue to give updates. If you have undergone a MonaLisa Touch vaginal rejuvenation procedure, and have suffered adverse side effects from these procedures, it is important to file a report through MedWatch. If you have any questions, or if you believe you have a case, contact us at KBA Attorneys.