In the past year, the Brazilian butt lift (BBL)has swarmed many TikTok feeds with women sharing their experiences, both good and bad. From 2017 to 2019, the number of BBL procedures has increased by about 38 percent. This is despite a 1 in 20,117 patient mortality rate when performed by a board-certified plastic surgeon in the United States, which is higher than the death rate of outpatient surgery overall. This has accompanied an overall 33 percent increase in cosmetic surgery for women between 2000 and 2020. Though, with a growing number of patients, the safety measures meant to guarantee their safety are disputed among experts.

Is Breast Augmentation Plastic Surgery?

Such controversy is present with the regulations regarding breast augmentation, the fourth most popular cosmetic procedure among women. On October 27, 2021, the Food and Drug Administration (FDA) strengthened safety measures for breast implants, limiting distribution of implants to healthcare providers that review an approved checklist of risks and information with patients to ensure they understand the nature of their procedure. This follows previous regulations on breast implants that have aimed to provide patients with more information regarding potential complications after some women reported developing symptoms, like chronic fatigue, migraines and a low-grade fever, of which they were not warned.

“This is something that I have been doing for many years and the vast majority [of doctors] have as well. This is a good thing that they are doing this, but we should already be doing this,” said Dr. Anthony Youn, a board-certified plastic surgeon who has over seven million fans on TikTok for his videos debunking myths and educating the public on plastic surgery. “Unfortunately, with some doctors their consultation is not about education, it's about selling.”

What Are the Risks of Breast Augmentation Surgery?

A lot of information on social media, according to Youn, tends to be advertisements, rather than credible material. There is little regulation, however, on who is able to perform plastic surgery in the United States. As Youn mentioned, not all doctors seem to put patient safety first. By law, any licensed doctor can perform plastic surgery regardless of their field and qualifications. Board certification is also not required for plastic surgeons. With such a lack of legal oversight, the idea behind this checklist is that it can help inch patients and surgeons closer to honest and informative conversations.

“With breast augmentation, it is very appealing that a patient may want it so badly, [overlooking] that there are potential downsides or risks or maintenance,” said Dr. Allison Lied, board-certified plastic surgeon and member of HealthyWomen’s Health Advisory Council. Recent regulations seek to provide patients with the information necessary to make an educated decision. Since cosmetic surgery is elective, it is especially important that there be informed consent as the procedure has the ability to put a healthy individual into a potentially life-threatening condition, according to both Lied and Youn. “I think [checklists are] good because it makes the patient slow down and consider those potentials.”

With these new mandates, surgeons must review the checklist with patients, and to confirm their understanding, patients must initial and sign the document. While this may be satisfactory enough to ensure that patients receive all information needed to guarantee their safety, Dr. Diana Zuckerman, president of the National Center for Health Research, is still concerned about the enforcement of the regulation.

“There is nothing to stop the surgeon... from saying ‘I have to give this [checklist] to you and you have to sign it, but honestly this is the safest procedure possible, and breast implants have been studied and you really don't have to worry at all,’” Zuckerman said. While she is glad to see further regulation, she questions how the FDA will be able to ensure the thoroughness of the consultation and discussion of the checklist. “Are the women actually reading [the checklist]? Are they understanding it?”

Despite the checklist being comprehensive and informative, the design of the checklist may hinder a patient's ability to understand the surgery and how a patient’s health may be affected, according to Zuckerman. “It starts with information you’ve already heard about... then, by the time they get to page four or five where the more important information is, are [patients] even going to be paying attention?”

The Best Breast Augmentation Information Versus FDA Hesitation

Before the release of the FDA’s most recent mandate, The Breast Implant Working Group, which includes Zuckerman along with surgeons, health policy experts and patients, spoke with the FDA to request a checklist that is more “user-friendly” than the one that the FDA had planned to release. Suggestions included clarifying potential risks, such as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), a cancer of the immune system, and Breast Implant Illness (BII), which includes symptoms like memory loss, chronic fatigue and a low-grade fever. They also advised implementing a more comprehensive list of possible symptoms with stronger descriptions. The Working Group recommended that the FDA work with manufacturers to create a certification course for surgeons using their implants as well in order to address the issue of enforcement for the checklist. While these experts and advocates believed that these revisions would help to ensure informed consent for patients, the FDA proceeded with their own checklist, largely ignoring the recommendations made by the team.

A number of experts, though, were satisfied with the FDA’s latest regulation. This discrepancy in opinion on the FDA’s regulations may be rooted in the research surrounding breast implants, or rather what research certain experts believe. While the Working Group referenced various studies in its correspondence with the FDA on the correlation between implants and BII, Lied states there is no link yet between implants and BII.

Though this regulation may be a step in the right direction, the FDA’s hesitancy to listen to recommendations and research from medical experts as well as insight from patients is not new. Women reporting symptoms of BII have been met with skepticism and hesitancy from doctors and experts alike, leading them to testify before the FDA that their illness exists. Later research, however, has supported their claims, showing that women experiencing symptoms of BII experienced relief within 30 days of their implants being removed.

(C) National Cancer Institute

How Can Breast Augmentation Patients Protect Themselves?

Despite disagreements between health experts on what risks can credibly be associated with breast implants, many agree that listening to patients is still important. “We have to start somewhere,” Lied said. “I think it opens our eyes to more research.”

While it is understandable that the FDA would be cautious about passing new regulations on something that is perhaps novel and under-researched, this is not the case for breast augmentation. With 193,073 individuals receiving breast augmentation surgery in 2020, the FDA’s hesitancy to recommendations and research may prove more dangerous than beneficial.

“No matter what's in writing and what's required, once you are in the doctor's office and it's just you and the doctor or you and the nurse, what is there to ensure you are getting accurate information?” said Zuckerman. Patients can do their own research on surgeons and procedures, but experts and policy makers in the field can further support their education and safety. For those women going under the knife and the experts supporting them, being listened to may be what defines the future of women’s health. “It's one thing to have a good idea, another to implement this idea and another idea to enforce it.”

If you want to see more of Honeysuckle's investigations into women's health issues, check out a few of our favorite spotlights.