An article in the Pensacola News Journal informs :

The wait is over. Women who want silicone breast implants can now have them -- thanks to the lifting of a 14-year ban by the U.S. Food and Drug Administration.

The implants were taken off the market in 1992 after some women complained that they leaked silicone into their bodies and caused serious health problems. Several extensive studies have since been conducted in and outside the United States, and some doctors say claims the implants are harmful have not been proven.

"Essentially, they found through fairly exhaustive studies that the new generation silicone implants are safe for people," said Dr. Peter Butler, a plastic surgeon with Gulf Coast Plastic Surgery in Gulf Breeze. "The main factor is that leaking does not cause tissue problems —— simply put, we don't want silicone leaking into our systems."

Butler and his partner, Dr. Jocelyn Leveque, both certified plastic surgeons, have been involved in a four-year U.S. Department of Health and Human Services study, which began in 1997. The agency appointed the Institute of Medicine of the National Academy of Sciences to conduct the study, which was underwritten by two California companies, Allergan Medical and Mentor Medical, manufacturers of the gel-based silicone implants.

Both doctors have enrolled some of their patients in the study, and each patient will be followed for at least 10 years.

"To date, Dr. Leveque has used silicone implants in 99 of her patients; I have used the implants in 73 cases in Pensacola," Butler said. Before then, Butler practiced in North Carolina. So far, he said none of their patients has experienced any problems.

When the implants were taken off the market, women were concerned that leaking silicon implants were causing a number of diseases. At the time, the doctors said, there was no research to disprove the claims. But new studies have found that the gel implants are much more cohesive and are safe for use.

This is good news for Jan Carlo, one of Butler's patients, who is also part of the study. Four months ago, Carlo, 50, was fitted with the implants following gastric bypass surgery. But not before doing some personal research.

"When you have surgery, you lose a lot of breast volume," said Carlo, a registered nurse. "I knew the silicone implants were more natural feeling and looking. I feel comfortable making the decision to have them."

Still, the FDA will continue to monitor the products and is requiring each company to conduct follow-up studies. Both companies are expected to track about 40,000 women for 10 years after they receive implants. The agency said package labeling should alert women who opt for the silicone implant to consider these factors as well:

· Breast implants are not lifetime devices, and a woman will likely need additional surgeries on her breast at least once over her lifetime.

· Many of the changes to a woman's breast following implementation are irreversible.

· Rupture of a silicone gel-filled breast implant is most often silent, which means that usually neither the woman nor her surgeon will know that her implants have ruptured.

· A woman will need regular screening MRI (magnetic resonance imaging) exams over her lifetime to determine if a rupture has occurred; a woman should have her first MRI three years after the initial implant surgery and every two years thereafter. The cost of MRI screening over a women's lifetime may exceed the cost of her initial surgery and may not be covered by medical insurance. And if the implant rupture is noted on an MRI, the implant should be removed and replaced, if needed.

"FDA has reviewed an extensive amount of data from clinical trials of women studied for up to four years, as well as a wealth of other information, to determine the benefits and risks of these products," said Dr. Daniel Schultz, FDA director, Center for Devices and Radiological Health. "The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices. This information is available in the product labeling and will enable women and their physicians to make informed decisions."

In Pensacola, Butler and Leveque plan to conduct a free seminar on Jan. 16 to discuss use of the gel-based silicone implants.