The FDA just tightened its safety requirements for breast implants

While job jobs are a safe and now familiar procedure, many of us have also seen sloppy. In reality, most cosmetic surgeries carry at least a small risk of poor results, but when it comes to breast implants, those risks can be dangerous or even fatal. This is one of the reasons the U.S. Food and Drug Administration took several steps last week to help patients considering breast implants make more informed decisions before surgery. Breast augmentation, one of the most common cosmetic surgeries in the United States, is an important procedure for those seeking reconstruction after breast cancer or those who simply want to transform the size or shape of their breasts. Because of this, the FDA continually updates its implant research and practices, and these newly imposed restrictions focus on patient awareness.

These new efforts include new labeling for all legally marketed implants, which will include a “patient decision checklist” to ensure those seeking implants fully understand the risks, benefits, and a full range of information regarding the specific implants they are considering. This checklist will be discussed between the patient and the provider, both of whom must sign the checklist before the augmentation can take place. (Implant makers will be required to post within 30 days of the FDA ruling, so we’ll update this story with what, exactly, these checklists include as we learn more. ) The FDA has also restricted the sale and distribution of breast implants. only to healthcare providers and facilities that provide this checklist to patients.

Pre-surgical checklists can help protect both the patient and the provider. “These lists ensure that each patient understands certain key points, are easier to review than long, disjointed documents, and they provide greater liability coverage for the surgeon and the manufacturer on these issues,” says Steven Teitelbaum, MD , Clinical Associate Professor of Plastic Surgery at UCLA School of Medicine. He points out that in his experience, these comprehensive lists rarely change a patient’s final decision about surgery.

“We’re all used to signing consents and waivers, whether it’s to enroll in a workout class or to update the operating system on our phones…. [this checklist] will help patients make more informed decisions, but the reality is that no one who is inclined to get an implant chooses not to do so when you show them the documents, ”he says. “Most patients who receive implants today have researched implants extensively online, and by the time they’re ready to sign the consent, they’ve already made up their minds. But this is where the patient-doctor relationship becomes more important: “What patients pay attention to is how the doctor explains each problem in his own words. A patient is probably inclined to trust the prospect [though which] their chosen surgeon describes the problems.


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