How the Breast Implant Registry Has Changed the Industry

With nearly 150,000 cases entered into the National Breast Implant Registry over the past 14 years, researchers have access to more data than ever to track and study breast implants. From recall monitoring and communication to serving as a resource for patients and doctors, the implant registry has made a significant impact since it began in 2012.

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What Is the National Breast Implant Registry?

Started in 2012, in collaboration with the Plastic Surgery Foundation, FDA, patients and breast implant manufacturers, the goal of the breast implant registry is to better track and collect data on implants and devices.

“The implant registry is a secure database that tracks breast implants—by recording information on the type, manufacturer and serial number,” explains New York plastic surgeon Mokhtar Asaadi, MD. “This ensures a traceable history for every device placed.”

“The idea was that by having a national registry, patients would have their information stored in a safe, secure location,” adds Tucson, AZ plastic surgeon Raman Mahabir, MD. “So if 10 years later, they went to see a surgeon for an implant replacement, that surgeon could access the registry and know what implants they had.  More importantly, if there was a recall, patients could be notified.”

The Trouble with Multiple Registries

One major sticking point for experts is that there isn’t just one registry.

“There are actually multiple breast implant registries,” explains Tucson, AZ plastic surgeon Silvia Kurtovic, MD. “The two highest profile registries are the NBIR (National Breast Implant Registry) and Aesthetic One. NBIR is through the American Society of Plastic Surgeons and The Plastic Surgery Foundation. And the second, Aesthetic One, is through The Aesthetic Society. Unfortunately, the two are not connected and do not collaborate. Surgeons are most likely entering cases into only one of the two registries. And the patient may not necessarily know which ones they’re being registered in. In my opinion, it’s actually causing a lot of confusion.”

Because the two registries don’t share data, the dream of a unified response in the event of a recall isn’t fully realized. But it is better than nothing.

“It really is a sad commentary that the two national plastic surgery societies refused to collaborate on just one national registry,” Dr. Mahabir notes. “That said, having a registry is better than having no registry. We saw that during the textured breast implant recall where patients that had implants that were causing cancer were unable to be notified, as there was no way to uniformly identify and contact them.”

What Are the Benefits of Being in the Implant Registry?

“For research purposes, the implant registry offers a huge amount of data, allowing researchers to hone in on a particular patient group or a type of implant,” explains Encino, CA plastic surgeon George Sanders, MD. “The more data the better, and we’ve already seen it work, when the registry’s tracking was immensely valuable to monitor textured implants and their potential for developing anaplastic large cell lymphoma. Without that large amount of data, you’re not going to pick up correlations like that.”

At the same time, a centralized registry also enables a swifter response to recalls.

“The registry allows surgeons and manufacturers to monitor implant performance, quickly identify trends or issues and take action if a recall or safety alert is necessary,” Dr. Asaadi adds. “This level of transparency has raised industry standards and improved patient trust.”

Additionally, the registry can be very useful to patients down the line. “Sometimes a patient will return for aesthetic services years after their initial augmentation, and their doctor has retired or it’s been so long that their medical records are no longer on file,” Dr. Sanders says. “And the registry holds that information, so we can always access exactly what they had.”

Who Might Not Want to Join?

Despite the advantages for researchers, practitioners and patients, not everyone is all-in on the implant registry.

“My patients in California are much more concerned with ensuring their privacy than they are with those benefits,” Dr. Sanders explains. “In an era of online security concerns and hacking, they can be particularly averse to a centralized registry of their data.”

Currently, joining the implant registry is opt-in. Providers and manufacturers do have their own internal systems for reaching out to patients impacted by recalls, but Dr. Kurtovic points out the registry is an improvement over this approach. “The old days of paper charts and pulling paper charts to see who had what implants are antiquated and has shown to be ineffective,” she says, “The registry is a huge step forward for patients’ safety.”