Could Breast Implant Registration Become Standard Operating Procedure?
by Dr. David Sayah
Breast enlargement is consistently one of the most popular cosmetic procedures in both the U.S. and worldwide. As its popularity endures, it grows increasingly important for both plastic surgeons and federal or international agencies to monitor breast implants in order to ensure the highest quality of patient care. Following some recent issues with French-made silicone implants, the UK has implemented a mandatory national registry to help notify patients of any potential concerns with their own implants. The question on the table for U.S. doctors and the FDA is whether the existing registration system, which is currently optional, should be made compulsory to further increase safety standards.
The Impact of the PIP Crisis
A recent article in The Guardian details the fallout from the discovery of faulty breast implants manufactured by French medical products manufacturer Poly Implant Prothese (PIP). After it was discovered that the implants illegally contained industrial grade silicone, it was important to be able to immediately find patients who had received them. Without the benefit of a national registry, it was difficult to isolate which patients were affected. It’s estimated that almost 50,000 UK women and up to 400,000 women internationally received these non-medical grade devices during their breast enlargement.
Because of sub-par records maintenance in many UK clinics and the lack of a central databank, offering immediate assistance to those women who were potentially impacted was overly challenging and time-consuming, and a more streamlined approach toward recalling the devices would certainly have been beneficial. In light of this failure and the ensuing scandal, the director of the UK’s National Health Service recommended a mandatory national registration system following a governmental review.
Should the U.S. Follow Suit?
Here in the U.S., the FDA currently approves a total of 5 types of medical grade breast implants. While these have been extensively tested for safety, the FDA emphasizes that breast implants do not have an unlimited lifespan. With recent recalls of other medical devices such as some artificial hips and urogynocologic surgical mesh (“transvaginal mesh”), it’s clear that there may be a benefit to a more systematic approach. As medical technology continues to develop and more and more synthetic devices are created for surgical use, it grows increasingly important to take all steps necessary to ensure patient health and wellbeing for years following surgery.
The Future of Medical Device Safety
With an eye toward the future, the International Breast Implant Registry (IBIR) was designed to be a first step toward a comprehensive international registry. Because of the sheer number of manufacturers, different national standards, and lack of data on long-term safety for various types of implants, this type of system should offer an improved degree of follow-up care for all breast enlargement patients.
The IBIR is a good starting point for both doctors and patients who want to take proactive steps for more stringent safety. The IBIR is administered with the cooperative participation of the International Confederation for Plastic, Reconstructive, & Aesthetic Surgery (IPRAS), American Society of Plastic Surgeons (ASPS), and the European and International Committee for Quality Assurance, Medical Technologies And Devices in Plastic Surgery (EQUAM). However, under current federal law, breast implant registration in the United States remains optional. Until or unless the U.S. mandates its own national registry, this international collaborative body offers the strongest movement toward standardized breast implant registration and safety.