Lots of questions about implants
Although the ban is lifted, women want to know about safety, cost
By DAVE NORDSTRAND
The Salinas Californian

The questions have been coming in since mid-November, when the Food and Drug Administration lifted its 14-year ban on silicone gel breast implants.

"People call wanting information as to the safety and if the implants are better," said Dr. Thomas Zewert, one of several Salinas-area plastic surgeons.

Callers also ask Zewert about the cost of the cosmetic implants at his office at 236 San Jose St., Salinas. The breast enlargers average $5,000 to $7,000 nationally.

Women seek cosmetic implants for two reasons, he said. One group wants larger breasts than they developed naturally for, er, social purposes.

"The other is for somebody who has laxity in the tissues or loss of tissue as they get older or breastfeed," Zewert said. "A breast implant provides the fill and fullness, especially in the upper part, that they had in youth."

First appeared in 1962

Silicone gel breast implants first appeared in 1962. That was before the FDA required proof that all medical devices be effective and safe. In 1992, citing safety concerns, the FDA banned silicone gel implants. Since then, they've been available only as part of research studies.

The ban was lifted following "rigorous scientific review," an FDA spokesman said.

"The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices," said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, in mid-November. "This information is available in the product labeling and will enable women and their physicians to make informed decisions."

Thicker shell

The new generation of implants come with a thicker shell.

That means less chance of a leak, manufacturers say. In some, the chemistry of the gel material has also changed, so that even after a tear the leak will remain contained, they say.

Allergan Corp. of Irvine and Mentor Corp. of Santa Barbara make the implants.

The FDA will continue to monitor the safety of the devices by requiring the companies to track 40,000 women for 10 years after receiving the implants.

Zewert said he will be among the Salinas-area physicians taking part in those studies.

The FDA added a warning when it lifted the ban: The implants don't last a lifetime. Most patients will face at least one additional surgery, the agency said.

Women should also get an MRI scan three years after an implantation to check for leaks, the FDA said, followed by MRIs every two years thereafter.

"The danger of leakage is that you develop a reaction to the gel, an inflammatory reaction," Zewert said. "You'd get (a sensation) like an irritation, then pain associated with that and increased scar tissue, and that can make an implant feel hard and cause pain."

Many women, he said, prefer the silicone gel for implants, saying it feels and looks more natural than other types.

Zewert, who holds a doctorate in chemistry, said he has taken part in studies on the safety and efficacy of the silicone gel implants over the past eight years.

Every patient needs to weigh with their physician the benefits and risks of getting an implant before taking that route, he said.

Contact Dave Nordstrand at dnordstrand@thecalifornian.com.

Dr. Zewert has privileges at the Community Hospital of the Monterey Peninsula (Monterey), Hazel Hawkins Hospital (Hollister), Salinas Valley Memorial Hospital ( Salinas), and Natividad Medical Center ( Salinas).

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