A new analysis by the Department of Plastic Surgery at the MD Anderson Cancer Center of the FDA’s large postapproval studies (LPAS) database suggests correlations between silicone breast implants and “an increased risk of certain rare harms.” Their conclusions are being disputed by a range of experts, as well as the FDA.
MD Anderson’s analysis combined data sets from a 2-year breast implant study by Allergan and a 7-year population survey by Mentor Corp (two of the largest implant manufacturers). It looked at the outcomes of 99,993 patients — recruited between February 2007 and March 2010 — who received breast implants manufactured by the companies. Of these patients, 56 percent had primary breast augmentation with silicone implants.
Patients reported incidences of Sjogren syndrome, scleroderma, rheumatoid arthritis, stillbirth, and melanoma at rates more than double the general population, though overall incidences remained low.
The report also cites high 4-year “satisfaction with breasts” (88.9) and “psychosocial well-being” (91.7). And it says that “silicone implants are associated with statistically decreased rates of fibromyalgia and lung cancer.”
How popular are breast implants?
The American Society of Plastic Surgery says that breast implants are used in nearly 300,000 augmentations and 100,000 reconstructions annually in the United States, so implant safety matters intimately to millions of women and their physicians. In 2017, 87% of the implants used in the U.S. were silicone.
Breast augmentation consistently ranks among the most researched topics on RealSelf, which hosts the world’s largest community of people who have undergone or are considering breast surgery. The 57,000 breast augmentation-related reviews on RealSelf show high patient satisfaction, with a 97% “Worth It” Rating for Breast Implants. RealSelf also has an active community related to breast implant removal.
What will this report change for plastic surgeons and patients?
We spoke with seven prominent, board-certified plastic surgeons who had read the study, asking if it changed what they will recommend to their patients.
Each one told us that they continue to believe — based on current science — that silicone implants are safe. La Jolla plastic surgeon Dr. Robert Singer told us, “Breast implants are the most studied device in the history of the FDA. And I agree with the FDA that the overwhelming amount of scientific studies show that they’re safe.”
Dr. Melinda Haws, a plastic surgeon in Nashville, is one of a growing number of female physicians who takes the issue very personally. “I have breast implants. My business partner has breast implants. We’re not taking our implants out over this. I would still recommend breast implants to my mom. I would still have my daughter get breast implants once she’s old enough, if she wanted them.”
Dr. Haws is prominently featured in a new video from the American Society for Aesthetic Plastic Surgery, with personal testimonials about breast implant safety from more than a dozen female board-certified plastic surgeons.
Though they say the report won’t change their clinical practice, doctors we spoke to expect it to lead to more patient discussions about risks and benefits.
Dr. Lara Devgan, a plastic surgeon in New York City and Chief Medical Officer at RealSelf, predicted “it will open up a lot more discussion and communication with patients, and I don’t think that’s a bad thing. Anything that pushes us toward more transparency and education is good.”
Vancouver, WA, plastic surgeon Dr. Allen Gabriel agreed. “This study gives plastic surgeons an opportunity to have deeper, more meaningful conversations with patients.” But he also said he would continue to focus on the most likely risk. “The number one driver for reoperation with breast implants in my practice remains capsular contracture, so that will continue to be what I primarily talk with my patients about.” (MD Anderson’s report notes that capsular contracture — a capsule of hardened scar tissue that contracts around the implant — “occurs in 7.2% of primary augmentations, 12.7% primary reconstructions, and is the most common reason for reoperation.”)
What are the study’s limitations?
The report itself says that it’s “not conclusive given limitations of LPAS reporting.”
In a statement and an editorial response in the Annals of Surgery, the FDA was more pointed, saying that while they “commend the work of our peers in studying the benefits and risks of breast implants,” they “respectfully disagree with the authors’ conclusions.” They cited “significant shortcomings with the study’s methodology and how the data is presented and concluded, including inconsistencies in the data and potential sources of bias. Because of these concerns, we urge the public and healthcare community to view this external assessment’s conclusions with caution.”
Each of the doctors we spoke to also expressed deep skepticism about the report’s methodology, citing concerns about how the data was collected, compiled and analyzed.
Most pointed out that the study combined two publicly available data sets with significant differences, creating what Dr. Devgan called “an apples and oranges issue.”
“Allergan diagnoses required confirmation” by a doctor, while the Mentor data included only self-reported outcomes. Dr. Singer echoed the sentiment of his colleagues when he said that “it’s always important to listen to patients, but that doesn’t equate with proven medical diagnoses by physicians.”
Patient follow-up over time also showed “significant attrition,” which doctors say may have led to selection bias and skewed results. Dr. Robert Cohen, a plastic surgeon with practices in Paradise Valley, AZ, and Los Angeles, stressed that “one possible bias to the data, which the authors admit in their article, is that people who feel like they’re having symptoms may be more likely to respond to these surveys than people who are doing fine.” Dr. Steven Teitelbaum, a plastic surgeon in Los Angeles, agreed. “I’ve been in many studies, and when patients are happy, they don’t want to schlep back and fill out ten-page forms.”
Several doctors underscored the need to put these potential risks in perspective. “An increased incidence of a rare event is still a rare event,” Dr. Devgan said.
Dallas-based plastic surgeon Dr. William P. Adams Jr. went so far as to question the report’s aims, saying that “trying to mine study data that’s extremely weak due to the design and collection flaws results in nothing of value for patients or physicians, and puts the motives of the authors in question.”
Dr. Devgan cautioned against jumping to conclusions drawn from correlations. She gave the example of women who get breast implants being “more likely to spend an increased amount of time in the sun, and therefore be more predisposed to melanoma.” Dr. Teitelbaum made a similar point, saying that “more implants are sold in warmer climates, like Miami and LA. People who like wearing bathing suits may be more likely to get implants, and they may be more destined to get melanoma.”
Dr. Mark Clemens, a professor of plastic surgery at MD Anderson and the report’s senior investigator, acknowledged to the Houston Chronicle that the report only notes correlations. “These findings aren’t meant to suggest implants caused these problems. They’re associations, which underscore the need for more research in this area.” But Dr. Clemens also told The Washington Post, “We completely stand behind this study, and we do feel it’s our best data to date.”
On the horizon: more breast implant safety data
The MD Anderson report says an ideal study would “require a head-to-head trial,” in partnership with the implant manufacturers.
Dr. Singer would welcome more rigorous research. “We need better follow-up and data collection. We need to identify the areas that are still unsolved. We need more information about how to avoid capsular contracture. We need more data on incidences of ALCL.” (In 2017, the FDA released a statement acknowledging that “individuals with breast implants have a risk of developing breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL.” Just one case of BI-ALCL was reported in the MD Anderson study.)
The FDA is heeding these calls for more comprehensive research. In their statement on September 14, they announced that they’re “working with multiple stakeholders to facilitate the development of the National Breast Implant Registry (NBIR) to provide a platform for evaluating real world data on the safety and performance of breast implants.” They believe this registry “will add helpful information to the FDA’s already extensive review of our own medical device reports, review of medical literature, assessment of post-approval studies, and meetings with patients.”
They’re also planning to hold a public meeting in 2019 “to ensure that patients and health care providers continue to have accurate, scientifically sound information about breast implant safety and effectiveness, and to promote public dialogue on the issue.” They’re forming a committee to spearhead this effort, which will include “several members from the medical community, academia and industry and, importantly, patient representatives.”
What should breast implant patients know?
“Anyone considering getting breast implants should feel empowered to have an honest conversation with their plastic surgeon about risks, benefits, alternatives and indications for the surgery,” said Dr. Devgan.
Dr. Singer urges patients to discuss potential risks with their doctor. “All procedures have risks. It’s the plastic surgeon’s responsibility to explain not only the pros but the potential complications with any procedure, and help the patient make an intelligent decision for themselves.”
Women considering breast augmentation may also find answers to many of their questions in RealSelf’s Breast Augmentation FAQ. If they haven’t yet chosen a doctor, RealSelf suggests these essential questions to ask at a consultation.
As for women who’ve already made the decision to get implants? “If breast implant patients ever experience something unusual or something that bothers them, they should see their plastic surgeons right away,” said Dr. Gabriel.
Dr. Devgan noted that “If you have breast implants and you’re not having any problems, then I don’t have any changed recommendations. Just keep up with recommended MRI screenings, your overall medical health, and routine histories and physicals with your primary care doctor.”
“The vast majority of patients who have implants, whether for aesthetic reasons or reconstruction, are happy they had the procedure and would do it again. And the majority of patients don’t have problems,” Dr. Singer concluded.
If you have questions about breast implants, talk to a board-certified doctor with deep experience performing breast implant surgery.