Breast implants.Photo: Getty
Patients seeking breast implants must now bewarned about the potential health risksbefore they can consent to surgery, the Food and Drug Administration said Wednesday.
The federal health agencylaid out new requirementsfor 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 arare, 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 cancermore 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.
“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,toldThe Washington Post. “We want patients to make informed decisions about whether or not breast implants are right for them.”
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, includingAshley Tisdale,Mina Suvari,Real Housewives of Orange County’sTamra JudgeandBacheloretteClare Crawley.
RELATED VIDEO:Tamra JudgeRemoves Breast Implants, Says She’s Already Noticing ‘Health Improvements’
Along with the checklist, the FDA also reiterated their recommendation from last year thatmanufacturers include a large warning on the boxes of breast implantsstating the possible complications, in a format similar to the cancer warnings on packs of cigarettes.
source: people.com
