Breast implants contain either saline or silicone. (The recalled devices aren't pictured.) Donna McWilliam/APPhoto
On July 24, 2019, breast implant manufacturer Allergan removed itsBIOCELL textured breast implants from the market after the Food and Drug Administration requested the manufacturer do so for safety reasons.
The request came afterU.S. health officials urged doctors to stay on the lookout for breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL, a rare form of cancer that's been linked to Allergan's textured breast implants.
In aletter the FDA sent to healthcare providers published in February 2019, the FDA said it wanted to increase awareness of BIA-ALCL, which the administrationfirst reported was linked to implants in 2011. Since then, more research has been published on this link, the letter said.
As of September 2018, the FDA had received 457 unique reports of BIA-ALCL, including nine deaths "which may be attributable" to the cancer, the letter added.It also called for doctors to report any cases of the condition to the FDA.
Currently, research estimates that the incidence of BIA-ALCL in people with implants can vary widely, from 1 in 3,817 patients to 1 in 30,000 patients, the FDA letter said.
The Allergan recall reminded consumers and doctors alike that breast implants, although common, are medical devices with potentially life-threatening side effects.
Some women began pursuing explants, or breast implant removal procedures, and some doctors have even stopped offering breast implants altogether thanks to thousands of women's reports of a mysterious "breast-implant illness" that gave them rashes, nausea, hair loss, and chronic inflammation.
In October, the FDA also urged all breast implant manufacturers to put black box warnings, the most serious type of medical warning, on all breast implants going forward.
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