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.

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.

In her recent Guardian article, “Can Breast Implants Make You Sick?” Adrienne Matei chronicles a patient’s struggle with Breast Implant Illness (BII), highlighting the often-overlooked systemic symptoms experienced by women with breast implants.

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.

BISA wants to keep women healthy, safe, and informed. How much do YOU really know about breast implants? Test you knowledge by taking our short quiz.

With Dr. Michelle Tarver’s appointment as the new director of CDRH, BISA hopes for stronger patient-focused oversight, contrasting with past controversies.

Maria Gmitro, president of Breast Implant Safety Alliance (BISA) BISA was recently quoted in The New York Times regarding the announcement of Dr. Michelle Tarver as the new FDA CDRH Director.

The FDA welcomes participation during the October 30, 2024 Patient Engagement Advisory Committee (PEAC) meeting on patient-centered informed consent in clinical study of FDA-regulated medical products.

BISA wants to keep women healthy, safe, and informed. Here are 5 important things all women should know about breast implants.

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

BISA worked improve the FDA’s Advisory Committee process by speaking at a recent listening session, along with a post-meeting with the Federation of American Scientists to discuss next steps.

BISA submitted public comments on the FDA’s recent draft guidance on improving the informed consent process.

BISA delves into the agency statements on the recently published recommendations about the removal of textured implants in asymptomatic patients.

BISA is part of the Patient, Consumer and Public Health Coalition. The Coalition recently sent a letter to the FDA’s Commissioner Robert Califf expressing concerns about Advisory Committees.

Maria Gmitro of Breast Implant Safety Alliance (BISA) addresses breast implant related illness and cancers, BIA-ALCL, and BIA-SCC with a focus on informed consent and her personal experience with breast implants, advocacy and the FDA.