The medical device landscape is witnessing growing innovation in specialised implantable technologies designed to address both functional and quality-of-life needs. In this evolving space, Himplant, a penile silicone implant procedure developed by Dr James Elist, has expanded its presence across international markets following regulatory approvals in several countries.
The recent approval from Argentina’s Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) marks another step in Himplant’s expansion across Latin America, where the procedure is already available in Mexico, Colombia and Chile. The approval also highlights the importance of regulatory evaluation, physician training and patient-safety protocols as implantable medical technologies enter new markets.
In this interview with MedTech Spectrum, Dr James Elist, M.D., inventor of the Himplant procedure, discusses the significance of the ANMAT approval, the regulatory and technical considerations involved, physician training and patient selection, clinical evidence and post-market experience, as well as Himplant’s plans for further expansion across Latin America and other global markets.
Regional Strategy: What does the ANMAT approval mean for Himplant’s Latin American expansion, and how significant is Argentina within your regional growth strategy?
Argentina is a key market for Himplant. The country has a unique, wonderful culture, people, and drive. We want to support men in Argentina and globally to achieve their full potential and confidence. Himplant is also now available in Mexico, Colombia, and Chile in Latin America with other markets coming online soon.
Regulatory Considerations: What were the key regulatory and technical considerations involved in securing ANMAT approval, and how does this process compare with regulatory requirements in other markets where Himplant is available?
ANMAT conducted a full, rigorous assessment of Himplant’s technical specifications, certification, published articles, track record, and other considerations. After this rigorous review, they approved Himplant for use in Argentina.
Physician Training: What does your physician training program cover, and how do you ensure that surgeons are adequately prepared to manage patient selection, surgical procedures, and potential complications?
We work with select surgeons in each market. We conduct training courses and proctoring to help surgeons and their clinical staff as they onboard this new therapy.
Patient Safety: As Himplant is a cosmetic medical device involving implantable silicone, what measures are in place to ensure patient safety, appropriate screening, and informed decision-making before the procedure?
We are very committed to patient safety first and foremost. We have standardized protocols, informed consent documents, and screening mechanisms to help with this key objective of safety.
Clinical Evidence: What clinical evidence and post-market experience have informed the development and adoption of Himplant, particularly regarding patient outcomes, satisfaction, and complication management?
We have published many articles in scientific, peer-reviewed journals regarding this penile silicone implant. We have published on high satisfaction rates (from patients and their partners), high patient confidence rates, and low complication rates. We have also published on the use of this device for the treatment of penile curvature, retractile penis, post-Peyronie’s disease improvement, and other conditions. Our goal is to help as many appropriately qualified men as we can.
Future Outlook: What are Himplant’s key priorities for expanding its physician network across Latin America, and are there plans to enter additional markets in the region or globally?
We plan to expand Himplant methodically around the world as part of our overall expansion of Himplant’s availability to patients.
