BISA President Speaks at MDIC Patient Forum in Washington, D.C.

Maria Gmitro, president and founder of the Breast Implant Safety Alliance (BISA), has been a member of the Medical Device Innovation Consortium (MDIC) since 2020. Currently, she serves on the Patient Advisory Group, SPI Post-Market Working Group, and the SPI Steering Committee.

The MDIC invited Gmitro to speak at the 2022 MDIC Annual Patient Forum and the MDIC Annual Public Forum in Washington, D.C., from Sept. 12-13. Industry, medtech leaders, device manufacturers, members of the FDA, and patient representatives were all in attendance for the forum, held at the JW Marriott. 

Gmitro was part of the sessions: “Patient Lived-Experience Panel - What the Device Manufacturers Should Know About Me” and “Transforming Patient Engagement in MedTech.”  Organized by Heidi Doshe, the patient. sessions centered on sharing personal experiences with medical devices.  The session was moderated by Dan Stephens, Ph.D., Global Advocacy Fellow of Boston Scientific and MDIC Steering Committee Chair. Other panelists included Erich Lin, Greg Guinther, and Maddie Gittens.

After describing her personal experience with breast implants, Gmitro made the following recommendations: 

• List patient advocacy organizations on manufacturer websites as resources.

• Provide educational opportunities for advocates to support them in better serving their patient community.

• Provide platforms for patients to speak on experience and share input in the total product life cycle.

• Provide reasonable compensation for patient representation, which should be a standard of best practice. This will also contribute to more diversity and more inclusive representation.

• Provide additional support for patients who are harmed, and now facing cancers caused by breast implants.

• Require UDIs for device tracking of all medical devices.

• Notify patients sooner when adverse events occur.

• Improve collection and reporting of safety data.

• Do not discontinue post-approval studies before fulfilling requirements. 

Maria’s Final Thoughts

“Overall, the experience was positive,” Gmitro said.”I’m grateful for the opportunity to have a platform to discuss concerns from our patient community.” 

Gmitro believes a broader understanding of patient advocate perspectives using the language used by industry can help to develop solutions, as well as innovative pathways to improve patient engagement and outcomes.

“Patients have valuable input, and everyone can benefit from keeping them engaged throughout the Total Product Life Cycle,” Gmitro explained.

As advocate and BIA-ALCL patient Terri McGregor said in 2019 at the first World Consensus Conference on BIA-ALCL in Rome, “Engage your patients. They are the ultimate stakeholder.”

Gmitro is especially grateful to Doshe, President and Founder of Tour de Heart, for organizing an outstanding experience for patient representatives. 

“Heidi is a dedicated mentor and patient advisor, who went above and beyond in making the patient panelists feel welcome… and most of all, valued,” Gmitro explained. “I also want to thank Dan Stephens, Kurt Gunasekaran, and Neil Ichiro Lauran for their continued support. I look forward to our future collaborative efforts.” 

If you have questions or concerns, please contact Maria Gmitro at maria@bisanonprofit.org.