The largest ever study of silicone breast implants has found the devices are generally safe but associated with a slightly higher risk of a few rare diseases, a controversial finding that quickly reheated the seemingly settled issue.
Silicone gel breast implants have had a bouncy history. In the 70s and 80s, plastic surgeons used them to enhance the bodies of a great many women. Then silicone implants were blamed for a host of serious chronic conditions. They were banned. Then they were approved. Now new research waves red flags. What’s going on?
A new study presents renewed alarms about the potential dangers of silicone implants
But first, a little background.
In the late 1980s, the theory that silicone implants trigger chronic disorders gave birth to a multitude of lawsuits. Eventually, billions of dollars were paid in settlements with hundreds of thousands of women around the world. The leading implant maker, Dow Corning, was forced into bankruptcy.
- In 1992, the FDA responded to the furor by banning all breast augmentation implants containing silicone. (Silicone implants were still allowed for use in reconstructive surgery and revisions of failed prior implantations.)
- In 2006, two silicone gel breast implant manufacturers (Allergan and Mentor) used pre-market clinical trials of their new products to persuade the FDA to again greenlight silicone implants.
The manufacturers said their new and improved silicone gel implants were safe enough to merit approval. But as a condition of approval, the FDA demanded that the manufacturers conduct extensive post-approval studies. The FDA required post-approval studies in order to assure the safety of the new implants.
- In 2011, the FDA produced an update on the results of the manufacturers’ post-approval studies. It concluded there was not enough information available to establish a link between silicone gel implants and any specific health problems.
Since the FDA granted reapproval in 2006, sales of silicone gel implants have soared
Approximately 300,000 women had breast enlargement surgeries in 2017. Most of those surgeries involved silicone implants. The silicone products are significantly more popular than the saline implants that received FDA approval during the silicone ban.
The Allergan and Mentor post-approval studies, conducted under orders from the FDA, created a database of follow-up information on almost 100,000 women. The women in these post-approval studies had received either silicone filled implants or saline implants with a silicone shell.
Results of a new study now show an association between silicone implants and multiple disorders
Last week, the University of Texas MD Anderson Cancer Center published an article in the Annals of Surgery. The Anderson study utilizes the same data created in the Allergan and Mentor post-approval studies. Dr. Mark Clemens, associate professor of plastic surgery at MD Anderson, was the lead author of the study. He notes that women with silicone filled implants had from 2 to 8 times higher rates of:
- connective tissue disorders
- autoimmune disorders
- skin cancer
- stillbirth
But Clemens is quick to point out that the Anderson study reveals only an association between the silicone implants and disease. No cause and effect relationship has yet been determined.
The FDA vigorously responds to the MD Anderson study on silicone implants
Binita Ashar is the director of the FDA’s Center for Devices and Radiological Health. She issued a press release which says the FDA “respectfully disagrees” with the conclusions of the Anderson study. Ashar asserts that there were, “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”.
The FDA and Clemens are in full agreement on one issue: the database created by Allergan and Mentor is seriously flawed. Those post-market studies initially included nearly 100,000 women. Within three years, Allergan and Mentor had somehow lost track of more than half of the women.
The FDA agrees with Clemons that further research on silicone implants is urgently mandated
Ashar’s press release states the FDA intends, “to hold a public meeting of the General and Plastic Surgery Devices Panel of our Medical Devices Advisory Committee in 2019 to ensure that patients and healthcare providers continue to have accurate, scientifically sound information about breast implant safety and effectiveness, and to promote public dialogue on the issue”.
Anaplastic large-cell lymphoma (ALCL) is connected to silicone gel implants
An independent “wildcard” factor played a role in the FDA’s decision to convene a comprehensive assembly on the issues of breast implant safety. A petition signed by 20,000 women was submitted to the FDA by a Facebook group called Breast Implant Victim Advocacy (BIVA).
BIVA’s petition focuses on a newly recognized cancer of the immune system, breast implant associated anaplastic large-cell lymphoma (BIA-ALCL). About 600 cases of ALCL have been diagnosed since its recognition in 2011. There seems to be a consensus of experts that it’s caused by silicone implants. And it’s probably no coincidence that the MD Anderson Cancer Center is recognized as a leader in the research and treatment of ALCL.
In response to the FDA’s critique of his study, Clemens diplomatically says, “We completely agree with the path forward that the FDA has laid out to get more information.”
So what’s the good news here? The FDA, the MD Anderson researchers, and BIVA all agree that the issue of breast implant safety is now being appropriately addressed. We’ll keep you posted. Thaïs
As one of the nation’s leading OB-GYNs, Dr. Thaïs Aliabadi offers the very best in gynecological and obstetric care. Supported by her warm professional team, Dr. Aliabadi treats women through all phases of life and fosters the special one-on-one relationship between patient and doctor. We invite you to establish care with Dr. Aliabadi. Please click here to make an appointment or call us at (844) 863-6700.
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