While breast implants have long been promoted as safe and effective, Breast Implant Safety Alliance (BISA) was published in an article that shines a light on the safety concerns and asks an important question: Are breast implants really as safe as we think? 

Are breast implants as safe as we think, and why do we still question the safety? Members of the Breast Implant Safety Alliance (BISA) reviewed a new article examining the reputation of the FDA concerning the safety of breast implants.

Jennifer Cook began as a breast implant patient. She learned about the risk of developing cancer from breast implants at a school play. A few months later, she started experiencing symptoms and was diagnosed with a cancer called BIA-ALCL. In this video, she shares her experience as a patient and as an advocate.

Save the date for the 10th International Breast Surgery Workshop (IBSW) and the 6th World Consensus Conference on BIA-ALCL, scheduled for April 11-12, 2025, in Tampa, Florida,

BISA’s president Maria Gmitro and BISA’s advisor data advocate Madris Kinard of Device Events were both quoted in MedTech Dive, citing the optimism regarding Dr. Michelle Tarver’s appointment as the new Director of CDRH at FDA.

It was encouraging to see the FDA gather expert opinions along with patient advocates and advisors to create improved guidance on more patient-centered informed consent materials for potential participants considering involvement in a clinical study. BISA compiled a few takeaways after the meeting.

Federal health regulators are alerting doctors to stop using BioZorb Markers due to reports of serious health problems among women who had these implants placed in their breast tissue for targeted cancer treatment.

The FDA has approved Motiva’s SmoothSilk Round and Round Ergonomix Silicone Gel-Filled Breast Implants for breast augmentation in people 22 and older.