Women Seeking Breast Implants Must Now Be Warned of the Potential Health Risks, FDA Says

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breast implants
breast implants

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Patients seeking breast implants must now be warned about the potential health risks before they can consent to surgery, the Food and Drug Administration said Wednesday.

The federal health agency laid out new requirements for breast implant surgery, which will mandate that plastic surgeons and manufacturers include a checklist of the possible complications that come with breast implants. The change comes after years of complaints and hearings with thousands of women who detailed side effects from their implants such as brain fog, fatigue and in some cases, the development of a rare, severe form of cancer.

Under the new rules, surgeons will run through a checklist with a potential patient "to help ensure that a patient receives and understands the benefits and risks of these devices." Patients will then have to sign their initials confirming that they have been informed of the possible side effects from surgery, such as breast pain, scarring and asymmetry and the risk of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), a rare form of cancer more common with textured breast implants.

Patients will also confirm that they've been informed of the possible systemic symptoms, which include "joint pain, fatigue, rash, memory loss and 'brain fog' that some patients have called breast implant illness," the FDA said.

RELATED: FDA Recommends Its Most Serious Warning Label for Breast Implants

"While the causes of these symptoms are unclear, some patients have reported relief of these symptoms with removal of their implants and surrounding scar tissue capsule, however not all patients may experience improvement in their symptoms," they said. "Researchers are working to better understand the possible link between breast implants and these symptoms."

The checklist also warns that "a breast implant is NOT a lifetime device" and typically last around eight to 10 years. Additionally, patients are to be made aware that they can rupture or leak "at any time."

"This is information that every patient contemplating breast implants should know," Binita Ashar, director of the Office of Surgical and Infection Control Devices in the FDA's Center for Devices and Radiological Health, told The Washington Post. "We want patients to make informed decisions about whether or not breast implants are right for them."

RELATED: 20 Stars Who Regretted Getting Breast Implants

In recent years, plastic surgeons are seeing a rise in requests for breast implant removals, and several celebrities have spoken out about making the change, including Ashley Tisdale, Mina Suvari, Real Housewives of Orange County's Tamra Judge and Bachelorette Clare Crawley.

RELATED VIDEO: Tamra Judge Removes Breast Implants, Says She's Already Noticing 'Health Improvements'

Tisdale, 36, said she chose to have hers removed after "struggling with minor health issues" that she believed were caused by her implants.

"Little by little I began struggling with minor health issues that just were not adding up — food sensitivities as well as gut issues … that I thought could be caused by my implants. So, last winter I decided to undergo implant removal," she said in Aug. 2020.

RELATED: FDA Warns Breast Implants Increase the Risk of a Rare Type of Lymphoma

Along with the checklist, the FDA also reiterated their recommendation from last year that manufacturers include a large warning on the boxes of breast implants stating the possible complications, in a format similar to the cancer warnings on packs of cigarettes.

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