Long-Term Complications Likely With Silicone Breast Implants

At Least 1 in 5 Patients Will Need Implant Removal Within 10 Years, FDA Warns

Mark Crane

Disclosures

June 22, 2011

June 22, 2011 — Silicone gel–filled breast implants are safe and effective when used according to their labeling, but the longer a woman has the implants, the more likely she is to experience complications, the US Food and Drug Administration (FDA) said in a new report released today.

"Breast implants are not lifetime devices," Jeffrey Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health, said during a telephone news conference. "One in 5 patients who received implants for breast augmentation will need them removed within 10 years of implantation. For patients who received implants for breast reconstruction, as many as half will require removal 10 years after implantation."

Women with silicone breast implants will need to monitor their breasts for the rest of their lives. To screen for silent ruptures, women should undergo magnetic resonance imaging 3 years after implantation, and then every 2 years thereafter, Dr. Shuren said. Women with saline implants do not need regular imaging.

When the FDA allowed silicone breast implants back on the market in November 2006, it required manufacturers to conduct follow-up studies to learn more about the long-term performance and safety of the devices. The FDA's report is based on preliminary safety data from these studies, as well as other safety information from recent scientific publications and adverse events reported to the agency.

The most frequently observed complications and adverse outcomes are tightening of the area around the implant (capsular contracture), additional surgeries, and implant removal. Other complications include a tear or hole in the outer shell (implant rupture), wrinkling, uneven appearance (asymmetry), scarring, pain, and infection.

Studies to date do not indicate that silicone breast implants cause breast cancer, reproductive problems, or connective tissue disease, such as rheumatoid arthritis, the FDA said. However, no study has been large enough or lasted long enough to completely rule out these and other rare complications.

"Most women report high levels of satisfaction" with their implants, Dr. Shuren said.

The FDA is working with the 2 manufacturers who make silicone breast implants, Allergan and Mentor, to address the challenges in collecting follow-up data on the women who have received these implants.

Approximately 5 to 10 million women worldwide have breast implants. In the United States, 296,203 breast augmentation procedures and 93,083 breast reconstruction procedures were performed last year, according to the American Society of Plastic Surgeons. About half the procedures used saline implants, and half used silicone implants.

Patients with either saline or silicone implants may have a very small risk for a rare cancer called anaplastic large-cell lymphoma (ALCL) adjacent to the implant. However, the risk is "profoundly small," said Dr. Shuren. "Since 1997, there are only 34 cases in the published literature, and at most 60 cases out of the 5 to 10 million women with implants worldwide," he said. "We don't yet know if there is a causal link."

When the FDA first released information about the risk in January, William Maisel, MD, MPH, chief scientist and deputy director for science in the FDA's Center for Devices and Radiologic Health, said the evidence suggests that the kind of ALCL found in conjunction with breast implants is less aggressive and is sometimes treatable by simply removing the implant, the capsule, and the collected fluid.

"The FDA will continue to monitor and collect safety and performance information on silicone gel–filled breast implants, but it is important that women with breast implants see their healthcare providers if they experience any symptoms," Dr. Shuren said. "Women who have enrolled in studies should continue to participate so that we may better understand the long-term performance of these implants and identify any potential problems."

The FDA is holding an expert advisory panel in the next few months to discuss how postapproval studies on breast implants can be more effective.

The FDA will issue an update at a future date on saline implants, Dr. Maisel said.

All serious adverse effects should be reported to the breast implant manufacturer and Medwatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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