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In an effort to educate women about the risks associated with breasts implants, the U.S. Food & Drug Administration has proposed manufacturers add a warning to information given to those considering getting them.
The recommendation was made following public outreach and a public advisory panel meeting held earlier this year on the topic of plastic surgery devices such as implants. Many women, according to the agency, have not been properly educated about the side effects associated with them—which can include, pain, scarring, and even cancer.
“We have heard from many women that they are not fully informed of the risks when considering breast implants,” the agency said in a statement. “They’ve stated that they need more information to facilitate meaningful conversations with their doctors and to make appropriate decisions for themselves.”
The side effects and health risks would be outlined in a “boxed warning,” that would communicate any possible problems associated with the devices. Additionally, a small booklet or brochure—which the FDA refers to as a checklist—would be provided to women considering implants.
“A checklist gives patients the opportunity to acknowledge individual risks of breast implants, such as potential risks from the surgery, the risk of BIA-ALCL [breast implant-associated anaplastic large cell lymphoma] and risk of implant rupture, among others,” the agency wrote in its statement.
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Before the recommendations are updated, they must undergo a public comment period. Those interested in weighing in on the topic can do so by clicking here.
Many women in the fitness industry have experienced severe symptoms—including migraines, fatigue, chronic inflammation, and even hair loss—that went away almost immediately after getting their implants taken out. The FDA hopes its recommendations could lead to fewer cases like theirs.
“We believe women should have thoughtful and balanced discussions with their health care providers about both the benefits and risks of breast implants based on clear and current information,” the FDA said. “This draft guidance is an important step in making that happen.”
Although implants are often marketed as lifelong devices, one in five women get them removed within eight to 10 years due to medical reasons, according to the FDA. The agency also wants companies to make that clear to women who might consider implants.
One model of implants, called textured implants, was recalled by Allergan Inc. in July after concerns were raised that they could be linked to a rare form of cancer. The FDA requested that recall after a report found that out of 573 people with breast implant-associated anaplastic large cell lymphoma, 481 reportedly had Allergan breast implants.
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