One year and six months after the FDA heard from dozens of women reporting a variety of breast implant related ailments, the federal agency has issued guidelines for breast implant manufacturers to include a black box warning (https://bit.ly/3kz9Hnm) to implants filled with saline or silicone gel. As we reflect on this important news during Breast Cancer Awareness Month 2020, we must celebrate the impact of the wider movement over the years. No one can argue that Breast Cancer Awareness Month has significantly increased awareness on a national level and raised critically needed funds to accelerate research. Even more promising, in recent years we have seen an increase in messaging beyond screening, including biomarker testing and “beyond-the-pink” public education. No doubt this is a month to reflect and be inspired by the strength, courage and effectiveness of all breast cancer communities, survivors and advocates.
The recent guidelines are the tangible result of the power of an organized and focused community. However, they also signify how much work still lies ahead. Our friend Andrea Ottaiano, Certified Health Coach, Health and Wellness Advocate, and Founder, Silver Lining Holistic Health and 13-year metastatic breast cancer survivor, has been an important voice and contributor behind these efforts. She enthusiastically joined other Breast Implant Illness advocates and survivors in Washington, D.C. back in March of 2019. It was the first open Advisory Board Meeting on the topic, held at the FDA, where 50 women testified about the health complications relating to Breast Implants. In her own words,
“We would like to see the guidelines call for a mandatory black box warning, not just a recommendation. Advocates have been fighting for manufacturer, surgeon, and FDA accountability for over 30 years. Equally important are establishing more long-term studies and effective Adverse Event reporting.”
Andrea is also a Breast Implant Safety Alliance Advocate. The Breast Implant Safety Alliance (BISA) has led the effort to change regulations and help protect women by ensuring patients are alerted to and understand the potential health risks of breast implants—from systemic symptoms categorized as “breast implant illness,” or BII, to a type of cancer called breast implant associated anaplastic large cell lymphoma (BIA-ALCL). According to Andrea, at least 6 women with BIA-ALCL testified back in March of 2019.
The guidelines are the result of years of orchestrated efforts by leaders like Maria Gmitro, BISA President. However, there is still much work to be done until the black box warning is required. BISA is continuing to push for full disclosure by working with state legislators to pass bills requiring surgeons to share the full list of possible health related risks. The evidence is clear. It is time for all parties to take responsibility for patient safety.
In talking with Andrea, she would like to see a larger paradigm shift where the healing process is the primary focus for breast cancer patients, not the aesthetic look you will get after surgery. Conversations and support centered on healing and optimal health during and following chemotherapy, radiation, and surgery should be the focus. In the meantime, ensuring that patients are made aware of all health risks associated with implants is imperative so women can make informed decisions. In her experience with breast cancer and dealing with her plastic surgeon, implants were upfront, as part of the “treatment plan”. When a woman is dealing with breast cancer, rounds of chemotherapy, surgery and radiation, it’s just not right to throw that into an already overwhelming intense decision making situation.
During Breast Cancer Awareness Month, and all awareness months, the best thing to do is act. To honor and effectively support these communities we need to move from awareness to action. Given scientific advances in treatment options across cancers and access to information, gone should be the days of passive education. Awareness months are best served to empower anyone impacted by cancer.
No matter your area of interest or passion, organizations like BISA are removing barriers and simplifying the process of joining their efforts by outlining specific action steps people can take to make a difference. Have a look at their “Call to Action Campaign” on their website for some inspiration (https://bit.ly/3ksT6Bt) and remember a donation is always an appreciated and highly impactful action to help further the work of important organizations like BISA.