Breast Implant history

Silicone gel implants have been around since the early 1960s; saline implants have been available since about the early '70s, Zuckerman said.

Silicone implants have a silicone shell and silicone gel filling. Saline implants have a silicone shell and salt-water filling.

Silicone is used because it's one of the most biocompatible products, Zuckerman said.

When implants were introduced, the FDA had no regulatory authority over any medical devices. That changed in 1976, and there was a huge backlog of devices needing evaluation.

Everything from latex gloves to heart valves was categorized by how safe they were considered, with devices like heart valves taking initial attention, Zuckerman said.

Breast implants were first placed in the safe group and eventually moved into the "we're very concerned" category, she said.

In 1991, the FDA required manufacturers to provide data on silicone gel implants.

Meanwhile, during depositions for a California lawsuit regarding silicone gel implants, documents expressing safety concerns that weren't given to the FDA were discovered.

A reporter was present and got copies. Zuckerman was among the first to see them.

People assume "a company isn't going to hide problems," she said.

Silicone gel implants were restricted in 1992, usually for use in women with cancer, abnormalities or who have had a silicone gel implant break.

In 1999, the FDA required data on saline implants — just as it had for silicone — and approved saline in 2000. The lag time dates to the backlog created in 1976.

"It's a very unusual situation," said Zuckerman of the implant-approval process.

It's a process that illustrates how the FDA still functions as it did in the 1930s when medical devices were few and medications weren't taken long-term, Zuckerman said. The FDA doesn't usually require long-term safety data, she added.

She points to recent problems with arthritis medications Vioxx and Celebrex.

"If a product is going to be used long-term, it should be studied long-term."

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