Breast implant monitoring is important to patients, advocates, physicians and even manufacturers. That’s why Allergan is backing the Aesthetic Society creation of the Patient App. The HIPAA-compliant personalized mobile app will securely store patient implant records and offer information and safety updates, as well give patients a way to send feedback.
The Patient App’s roots go back to a March FDA General and Plastic Surgery Devices panel meeting about the risks and safety of breast implants. Patients and advocates in attendance told the group they wanted better-informed consent and updated information about their breast implants. However, on the manufacturers’ side, there was a need to better collect data and monitor patients so they could deliver that information.
“The new mobile app technology makes it possible to connect previously siloed data, giving patients and their providers more proactive control over their health and safety,” Carrie Strom, Allergan senior VP for medical aesthetics in the U.S., said in an email interview.
“As healthcare becomes more personalized, Allergan is utilizing the latest in technology and innovation to compete with traditional methods in the delivery of highly personalized health (medical aesthetic) education. Part of that innovation is building tools that allow for a more seamless engagement, which is what the Patient App is designed to do,” she added.
Patients will be able to download the app, expected for release in 2020, but Allergan will also promote the Patient App on its Natrelle breast implant digital and social media channels as well as in in-office brochures. The Aesthetic Society plans to promote the app to plastic surgeons and encourage them to talk directly to their patients about the app.
Allergan sales of breast implants in 2018 hit $393 million worldwide, with $263 million of that total coming from the U.S. However, that revenue has dropped this year as Allergan faced safety issues with one of its products.
This summer, the drugmaker removed its Biocell textured breast implants and tissue expanders from the market at the request of the FDA after the agency’s investigation into reported cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), including 33 deaths. The FDA reported that of 573 new cases, 481 patients were reported to have Allergan breast implants at the time of diagnosis, and 12 of the 13 deaths where the manufacturer was known had Allergan implants at diagnosis.