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FDA Considers Black Box Warning for all Breast Implants

By: Mariel Carbone
ABC WCPO 9 Cincinnati

Excerpts:

In March 2019, at an FDA conference about breast implants, women, doctors and surgeons shared harrowing stories of complications connected to receiving implants after a mastectomy.

“I experienced extreme exhaustion, rapid weight gain, paralyzing brain fog,” Julie Elliot testified.

“I was completely bedridden, waiting to die,” said Terry Diaz, who described herself as a breast implant survivor. “I couldn’t even walk up a flight of stairs.”

The women said their implants caused these issues. Others experienced an even more serious complication: A rare form of cancer called breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL, in which lymphoma develops in the tissue around the implant.

“Life as I knew it ceased to exist,” Terry McGregor, a BIA-ALCL survivor, told the FDA panel. “Four years ago, I was diagnosed with ALCL from breast implants that were six years old. My diagnosis was stage four. The joy of life was cut short by a profit-driven, man-made cancer.”

The FDA released more findings about BIA-ALCL in July, months after the conference. According to U.S. and global medical device reports, there have been 573 reports of BIA-ALCL. Thirty-three patients died.

Of those cases, the FDA said a majority are linked to a single pharmaceutical manufacturer, Allergan, and its textured BIOCELL implants. The company recalled the implants on July 24.

“Patient safety is a priority for Allergan,” the company said in a news release announcing the recall. “Patients are advised to speak with their plastic surgeon about the risks and benefits of their implant type should they have any concerns.”

In October, the FDA proposed adding a black box warning to all breast implants warning patients about the potential side effects of breast implant illness and BIA-ALCL.

Read the full article at ABC WCPO 9 Cincinnati