With nearly 150,000 cases entered into the National Breast Implant Registry and over 120,000 entered into the American Registry for Breast Implant Surveillance, 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, these implant registries have made a significant impact since it began.
Featured Experts
- Mokhtar Asaadi, MD is a board-certified plastic surgeon in New York
- Raman Mahabir, MD is a board-certified plastic surgeon in Tucson, AZ
- Silvia Kurtovic, MD is a board-certified plastic surgeon in Tucson, AZ
- George Sanders, MD is a board-certified plastic surgeon in Encino, CA
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.”
What Is The American Registry for Breast Implant Surveillance?
Utilizing a simple QR code scan, the American Registry for Breast Implant Surveillance (ARISE) offers a physician-friendly way to easily enter breast implant data. FDA-recognized, ARISE was started in collaboration with Allergan in 2017, and offers a comprehensive patient portal, a secure registry, a wealth of research data and a way for manufacturers to contact patients in the event of issues with a breast implant type.
“The registry provides research data for the Aesthetic Society’s educational and research foundation,” notes Laguna Beach, CA plastic surgeon Dan C. Mills, MD. “There are many factors in a breast augmentation, including whether or not the implant is placed under the muscle or over the muscle, smooth wall versus textured, inframammary or transaxillary incisions. All of these will all give different results, and the registry allows us to do research on each of these approaches with all the different companies that could possibly find trends.”
Wall Township, NJ plastic surgeon Caroline Glicksman, MD adds that ARISE’s new oversight committee includes two members of the FDA’s Center for Devices and Radiological Health (CDRH). “ARISE is also launching the first prospective clinical trial enrolling 1,000 patients who will be followed from day of augmentation for two years,” she explains.
This ability to follow-up with patients allows for more comprehensive tracking of even the smallest details.
“We are able to determine who has more capsular contractures, and what breast implant approach results in capsular contracture or infection or even rupture over the years,” Dr. Mills adds. “It will track all of these differences down to the granular part of if you use a funnel to put the implant in or if you cover the nipple to keep bacteria from coming out in the middle of the surgery or what irrigation you use in the pocket to cut down on bacterial contamination.”
In addition, the patient portal’s comprehensive information allows patients to see a full view of their implants. “It includes everything from the serial number, lot number, size, style number, and if it is textured or smooth wall, if it is gummy bear or fourth or third generation gel,” says Dr. Mills. “They can easily take that information to another doctors office to collaborate with what they’re wanting to do.”
The Trouble with Multiple Registries
One major sticking point for experts is that these two registries don’t collaborate.
“There are actually two breast implant registries,” explains Tucson, AZ plastic surgeon Silvia Kurtovic, MD. “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.
“We have attempted to collaborate on several occasions,” explains Dr. Mills. “And we are optimistic about collaboration in the future, but NBIR is currently refusing unless ARISE provides all it’s proprietary data, which is a hurdle we haven’t been able to overcome, yet.”
“It really is a sad commentary that the two national plastic surgery societies do not collaborate on just one national registry,” Dr. Mahabir notes. “That said, having these registries 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, both registries offer 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 both registries 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 joining one of the two registries 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 registries are a huge step forward for patients’ safety.”
