FDA’s Draft Breast Implant Guidance Still Needs to be Strengthened, Made Mandatory

For Immediate Release                                                                                         

October 23, 2019

Contact: Connie Matthiessen
Communications Manager
415.243.9301×15
cmatthiessen@bcaction.org

SAN FRANCISCO, CALIFORNIA (October 23, 2019) – Breast Cancer Action (BCAction), the watchdog for the breast cancer movement, today recognizes an important, and overdue, step to strengthen labeling and informed consent for breast implants with the Food and Drug Administration (FDA) release of a new draft guidance on the topic.

For decades, thousands of women have reported serious health harms associated with their breast implants, as early as 1995 rallying in Washington DC to call for stronger regulation. Despite several FDA hearings over the years, the most recent of which was March 2019, the FDA was slow to act and many women were never warned of the serious, and potentially life-threatening, risks associated with breast implants.

“Tens of thousands of women have been harmed by their breast implants, due to foot-dragging by industry and inaction by the FDA. Many people are shocked to learn these medical devices have never been proven to be safe and effective,” said Karuna Jaggar, Executive Director of Breast Cancer Action. “Although the risks associated with implants are rare, they can harm a large number of women due to the popularity of these devices.” 

Jaggar serves on the Breast Implant Working Group and the Executive Committee for the Breast Device Collaborative Community. According to the draft guidance released by the FDA, the risks associated with breast implants include breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), Breast Implant Illness (BII), disfigurement, and disability, to name a few.

It is not clear if the draft guidance will be voluntary or mandatory. “Not only does the draft guidance released by FDA need to be strengthened, it is essential that the warning language is mandatory,” said Jaggar. “Women deserve to know the risks when making life-changing and deeply personal medical decisions.”

Boxed warnings, aimed at consumers and health care providers, describe risks associated with drugs and medical devices and are the strongest warning required by the FDA. “Standardized language for informed consent and label warning is especially important given the fact that many plastic surgeons minimize the risks of breast implants, assuring women they are safe when counseling patients who are considering this surgery,” said Jaggar. 

 “For too long the FDA gave manufacturers of breast implants a pass when it came to collecting important data on the long-term harms of breast implants,” said Jaggar “It’s almost as if manufacturers of breast implants figured out that the best way to avoid telling women about potential harms of these problematic medical devices was to not collect the data in the first place,” said Jaggar. “But the truth is seeping out—just like the silicone seeps out of many implants.”

“As is so often the case, for decades women’s reported symptoms have been dismissed. But the problem wasn’t in their heads, it was in their chests.”

Breast Cancer Action provides unbiased information to anyone who needs it about their breast cancer treatment options. “Many women are made to feel that reconstruction after mastectomy for breast cancer is an essential part of the treatment plan,” noted Jaggar. “The draft informed consent checklist appropriately notes that breast reconstruction is an elective procedure and women may choose not to undergo reconstruction after breast cancer treatment.”

The FDA is accepting public comments through December 23rd on the draft guidance.  “We know that manufacturers will be working hard to weaken the language but we’ll continue to push for strong regulation that puts women’s health before corporate profit. It’s one of the reasons we refuse corporate funding that could create a conflict of interest, so we can go toe-to-toe with industry when we need to.”

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Breast Cancer Action (www.bcaction.org) is a national education and activist nonprofit organization whose mission is to achieve health justice for all women at risk of and living with breast cancer. BCAction has a strict conflict of interest policy and refuses to accept corporate funding from companies or organizations that profit from or contribute to the breast cancer epidemic.

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