The term “battle of the bulge” is commonly associated with military history or medical conditions, but it has taken on a new legal meaning in a recent intellectual property dispute between two companies that manufacture cosmetic penile implants. The case, International Medical Devices, Inc., et al. v. Robert Cornell, et al., Case No. 25-1580, Dkt. 53 (Fed. Cir. Apr. 17, 2026), centers on the Penuma and Augmenta devices, which claim to enhance penile size and structure. The ruling highlights the complex interplay between trade secrets and patent law in the medical device industry.
Cosmetic procedures often have both aesthetic and medical implications. For example, the Women’s Health and Cancer Rights Act of 1998 (WHCRA) requires health insurance plans covering breast cancer mastectomies to also fund post-mastectomy reconstruction, highlighting the psychological and physical benefits of such procedures. Similarly, men facing trauma, congenital conditions, or other penile issues may benefit from “cosmetic” penile implants that restore function and self-esteem. These implants are not purely aesthetic; they can address functional impairments and psychological distress.
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The recent legal outcome in the International Medical Devices case reveals a key distinction in IP disputes: trade secrets versus existing patents. The trial court identified four trade secrets related to the Penuma device, including the incorporation of internal pockets in the silicone body and mesh tabs for tissue ingrowth. The jury ruled these trade secrets were both “protectable and misappropriated.”
A central issue in the case was the definition of a trade secret. As noted in In re Providian Credit Card Cases (116 Cal. Rptr. 2d 833, Cal. Ct. App. 2002), public disclosure “is fatal to the existence of a trade secret.” The burden of proof lies with the plaintiff to demonstrate that the information is not generally known. The court in International Medical Devices found that the plaintiffs’ claims lacked sufficient evidence to support their assertion that the trade secrets were not publicly available.
The U.S. Supreme Court has long recognized that patent law and trade-secret law can coexist, but with a critical caveat: once information is publicly disclosed—whether in a patent, medical device application, or other means—trade secrecy ceases. The ruling reinforces the importance of distinguishing between trade secrets and patents, particularly in cases where information is publicly available.
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The outcome of the International Medical Devices case has broader implications for the medical device industry. It reinforces the importance of distinguishing between trade secrets and patents, particularly in cases where information is publicly available. The ruling also shows the need for companies to handle IP law carefully, ensuring that their claims are legally defensible.
As the case illustrates, the availability of multiple cosmetic penile implant options is key for patient choice and competition. Just as there are various breast implant designs, the medical device industry benefits from a range of solutions that address both aesthetic and functional needs. This approach helps prevent monopolies and ensures that patients have access to diverse, high-quality care.
