National Breast Implant Registry to improve patient safety By Paul Snyder

affirming to me when I see the women in my practice in Boston, who have similarities in what they think about, worry about and the things that make them happy.

It’s with this in mind that the plastic surgery community needs to continue to be there for women who are going through their own breastcancer journeys. We can continue global education when it comes to capacity building, techniques and know-how – how to do procedures safely in their own environment. How we measure that is difficult, but there are things we can look out for from community and patient perspectives.

Although I made a recent trip to Dar es Salaam, there’s a special reason I’m returning right now. While the Aga Khan hospital our program works with typically helps to finance these trips, the local community recently established its own fundraiser and donated money so that our surgeons could return and provide procedures for more patients this summer. The community sees the value of reconstructive surgery capacity-building and the education we can provide. We think about metrics differently in the United States in terms of measurements and figures that we can count, but to me, this local effort is just as significant. A community in Tanzania is saying, “Come back and expand this program.” As an example of this, I’ve been working for several years with a young surgeon at the public hospital there. Although he hasn’t had plastic surgery training, he is skilled in plastic surgery and he and I have worked together multiple times, building his skill set in reconstructive breast surgery. On this trip, I’ll be assisting him. As I said earlier, the little things are adding up.

We need to continue building upon that so that we can be there for as many women as we can.

Registry is a vital step toward patient safety

By Paul Snyder

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, more than six years in the making, debuted in 2018 and is available to any site performing breast implant procedures. The registry is a prospective, non-interventional, populationbased, outcomes- and safety-surveillance registry and quality-improvement initiative. The NBIR collects 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.

“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 cochair and helped steer the registry’s creation.

The registry enables 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.

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 – Charles Verheyden, MD, PhD, past president of The PSF and co-chair of the registry, 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. The NBIR looks to change that.

“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.