Silicone Breast Implants Linked to Number of Complications, but FDA Critical of Study

Silicone Breast Implants Linked to Number of Complications, but FDA Critical of Study

A study suggests that silicone breast implants are associated with a higher risk of certain autoimmune disorders, as well as stillbirth and melanoma, but the FDA disagrees with the results.
Oct 5, 2018.

Many, but not all, women who have mastectomy to treat breast cancer go on to have one or both breasts reconstructed. There are many ways to reconstruct a breast. Tissue from the back, belly, buttocks, or other part of the body can be used to create a new breast. Doctors call this autologous reconstruction. Saline or silicone gel implants are another option. In some cases, an implant is added after autologous reconstruction.

A study done by researchers at the University of Texas MD Anderson Cancer Center suggests that silicone breast implants are associated with a higher risk of certain autoimmune disorders, as well as stillbirth and melanoma. Still, the U.S. Food and Drug Administration (FDA) criticized the study and issued a statement disagreeing with the results.

The research was published online on Sept. 14, 2018, by the journal Annals of Surgery. Read the abstract of “US FDA Breast Implant Postapproval Studies: Long-term Outcomes in 99,993 Patients.

Read the FDA statement on the study.

In the early 1990s, the FDA banned silicone breast implants in response to public concerns about health risks including cancer, connective tissue diseases, and autoimmune disorders. Later research found no link between breast implants and these diseases. In 2006, the FDA approved silicone gel-filled implants from two manufacturers, Allergan and Mentor Corp., requiring the manufacturers conduct large studies to monitor long-term health and safety outcomes.

Editor’s Note: On July 24, 2019, Allergan announced a global recall of Biocell textured breast implants and tissue expanders after the FDA requested the recall.

To do this study, which the researchers said was the largest study done so far on breast implant outcomes, the researchers looked at the medical records of 99,993 women who had implants inserted who were enrolled in the long-term health and safety studies. More than 80,000 of the women had silicone implants; the rest had saline implants.

Most of the women had the implants inserted for breast enlargement:

  • 72% of the women had breast enlargement

  • 15% had breast enlargement revision

  • 10% had breast reconstruction

  • 3% had breast reconstruction revision

The researchers found that compared to women in the general population, women with silicone implants were:

  • 8 times more likely to be diagnosed with Sjögren syndrome, an autoimmune disorder characterized by dry eyes and a dry mouth

  • 7 times more likely to be diagnosed with scleroderma, a group of autoimmune diseases that cause the skin and connective tissues to become hard and tighten

  • nearly 6 times more likely to be diagnosed with rheumatoid arthritis

  • nearly 4 times more likely to be diagnosed with melanoma, a rare but deadly type of skin cancer

  • more than twice as likely to have a pregnancy end in stillbirth

Compared to women with saline implants, women with silicone implants were almost twice as likely to experience capsular contracture (scarring around the implant).

The researchers found only one case of anaplastic large-cell lymphoma (ALCL), a very rare type of cancer linked to breast implants. In 2017, the FDA updated its warning on the link between ALCL and textured breast implants.

In a statement, Binita Ashar, M.D., of the FDA Center for Devices and Radiological Health, disagreed with the conclusions and said the agency had concerns about “significant shortcomings with the study’s methodology and how the data [are] presented and concluded, including inconsistences in the data and potential sources of bias.

“Because of these concerns,” the statement continued, “we urge the public and healthcare community to view this external assessment’s conclusions with caution. …While the agency continues to believe that the weight of the currently available scientific evidence does not conclusively demonstrate an association between breast implants and connective tissue diseases, we respect studies like the ones published in Annals of Surgery by our peers.”

“I respect [the FDA’s] decision -- essentially, they acknowledged that we found an association within our study, but there were inherent limitations, which we were open about,” said Mark Clemens, M.D., of the MD Anderson Cancer Center and senior author of the study, in an interview. Clemens added that a 2016 meta-analysis found the same associations as his study.

The FDA has acknowledged the studies, but has said it cannot say there is a direct relationship between the implants and the complications found in the studies.

It’s worth noting that only 10% of the women in this study had an implant inserted for breast reconstruction. The researchers did not report the rate of complications in women who had reconstruction compared to women who had breast enlargement. This makes it hard to tell if something about breast cancer or its treatment contributed to any of the complications.

If you are considering breast reconstruction with an implant, it makes sense to talk to your doctor about the risks and benefits of implants, including the differences between saline and silicone implants, as well as the differences between textured and smooth implants. Together, you can make the best decision for your unique situation.

If you have a breast implant, call your doctor if you have symptoms or problems with your implant, such as pain, lumps, swelling, or asymmetry.

Visit the Breast Reconstruction section to learn more about breast implant surgery and other breast reconstruction options.

To talk with others about breast implant reconstruction and its potential risks, visit the Discussion Board forum Breast Reconstruction.

— Last updated on October 3, 2022, 11:10 PM

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