FDA Says Silicone Breast Implant Recipients Must be Monitored for Complications

In an update on the safety of < "https://www.yourlawyer.com/topics/overview/Breast-Implant-ALCL-Lymphoma-Anaplastic-Large-Cell-Lymphoma-Lawsuit-Lawyer">silicone gel breast implants, the U.S. Food & Drug Administration (FDA) is warning that the devices come with certain risks. It is likely, the agency said, that eventually women who receive silicone breast implants will need to have them removed or replaced due to a variety of problems. For this reason, women who receive silicone breast implants must be monitored for the rest of their lives.

Possible breast implant complications include the occurrence of a rare cancer called anaplastic large cell lymphoma or ALCL. Earlier this year, the FDA warned that 60 cases of ALCL have been reported among the 5 to 10 million patients with both silicone and saline breast implants. According to a report from the Boston Globe, the cancer normally occurs in the breast in only 3 in 100 million women.

According to the FDA, the longer a woman has breast implants, the more likely she is to have complications. 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 1 in 2 will require removal within 10 years of implantation.

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, the agency said.

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

“It is important that women with breast implants who experience any symptoms see their health care providers,” Jeffrey Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health, said in a statement released yesterday. “Women who have enrolled in clinical studies should continue to participate so that we can better understand the long-term performance of these implants and identify any potential problems.”

At one time, silicone breast implants had been banned by the FDA for augmentation use after concerns were raised about their safety risks. They were reapproved in 2006, but the agency required the manufacturers of the devices, Allergan and Mentor, to conduct follow-up studies to learn more about the long-term performance and safety of the devices. The FDA’s latest update is based on preliminary results of these studies, which involved 40,000 women