After years in the making, NBIR launches at annual meeting
It's been 57 years since Thomas Cronin, MD, and Frank Gerow, MD, helped develop the first silicone breast implant, and 56 years since the first augmentation mammoplasty was performed. Now, for the first time in the United States, a national registry is in place to track the devices and provide plastic surgeons and patients with more concrete information on breast implants than has ever been available.
In collaboration with the FDA and breast implant manufacturers, The PSF developed the National Breast Implant Registry (NBIR) to strengthen national surveillance for these devices in the United States. The NBIR, which is more than six years in the making, is available to any site performing breast implant procedures. The registry is a prospective, non-interventional, population-based, outcomes- and safety-surveillance registry and quality-improvement initiative. The NBIR will collect clinical, procedural and outcomes data at the time of operation and any subsequent reoperations. Data collection is anticipated to continue as long as breast implants are being manufactured – and registration opened during Plastic Surgery The Meeting 2018 in Chicago in late September.
"This is an important mechanism by which we can continue to ensure the safety of breast implant surgery," says The PSF President Andrea Pusic, MD, MHS, who is also the NBIR Subcommittee co-chair and helped steer the registry's creation.
At press time, the NBIR had already gained nearly 100 sites registered from solo, private and academic practitioners.
The registry will enable both plastic surgeons and breast implant manufacturers to identify trends and other information that can be used to improve the safety of implants for both current and future patients. Patient demographic, risk/co-morbidity, procedural, adverse and complication/adverse event data related to breast implants are all types of information that can be collected through the registry.
"Through interactive dashboard reports, the NBIR will give ASPS members invaluable insights into their own outcomes and the ability to benchmark their performance with colleagues nationally," Dr. Pusic says.
During the PSN Presidents Forum at Plastic Surgery The Meeting 2018, Dr. Pusic noted the timing of the registry is fortuitous for the specialty ahead of a meeting that the FDA will host next year. The FDA called the meeting following the publication of a recent study that suggested a link between silicone breast implants and higher rates of rare health conditions. Although the agency refuted the link, it wants to review all available data on the topic, and Dr. Pusic says she would love to show the FDA panel robust engagement around the registry. Moreover, she adds that breast implant safety continues to be a frequently covered topic in the media.
"Through the NBIR, we will collect the data that we need to communicate our commitment to patient safety," she says.
Seeking hard numbers
Charles Verheyden, MD, past president of The PSF, and the other co-chair of the registry, says the effort to establish the NBIR has been a long time coming.
"I was just talking to Dennis Lynch, MD, my former partner, who was chairman of the Government Relations Committee in the early 1990s when we went through the 'breast implant crisis,'" Dr. Verheyden says. "We recalled at the time that we had no data at all about breast implants and the implant companies really didn't have any meaningful data, either. As we started work on our registries, and time went along, people began thinking about a registry to look at what we were actually doing with breast implants."
The FDA has been pushing the development of registries for several specialties based on the quality of information they can get on medical devices. Although there have been several papers and journal articles written about breast implants and various issues surrounding them – Dr. Verheyden notes a literary review on the devices that Tufts University did for Annals of Internal Medicine that included nearly 6,000 published works – the data has not produced hard numbers for plastic surgeons or their patients.
"I'm excited about having good data," he says. "Even though we've been using breast implants for more than half a century, we still don't have the hard numbers on capsule contracture rate, rupture rate, how many reoperations these patients have or how long an implant lasts. It will be good to have numbers you can hang your hat on."
The registry is supported by Allergan, Mentor, Sientra and Ideal Implant. You can register for the NBIR by visiting thepsf.org/nbir.