FDA lifts ban on silicone implants

On Nov. 17, the FDA approved the use of silicone implants for breast augmentation and reconstruction, 14 years after a ban was put in place.

Numerous studies with the silicone implants were conducted during the years the ban was in effect. The silicone implants were available during that time to patients in need of reconstructive surgeries, and many of those patients were involved in the studies that led to the lifting of the ban.

Augmentation education

While studies have dispelled any evidence that silicone implants can cause diseases after rupturing, Dr. Carl Price, a plastic surgeon with Ferrell-Duncan Clinic’s Center for Plastic Surgery, and Dr. Bharat Shah, a plastic surgeon with St. John’s Clinic Plastic Surgery, said patients still need to be aware of the differences between saline and silicone.

“It’s all about the patients educating themselves and making an informed decision based on what’s best for them,” Price said.

Shah said that patients who had saline implants during the ban on silicone are generally very happy with them.

“It’s just that in many cases, silicone gel offers some different options,” Shah added. “The best way to know is to hold them in your hand.”

Both Price and Shah have received patient inquiries about silicone implants since Nov. 17, but neither have performed surgeries with them since the ban was lifted.

Scientific data

Ferrell-Duncan’s Price said implants – in one form or another – have been around since the 1960s.

When the FDA began to regulate medical devices due to amendments to the Federal Food, Drug and Cosmetic Act in 1976, all devices already in the market were grandfathered in, Price added, but there was a stipulation that at some point, the grandfathered devices would have to go through an approval process.

In the late 1980s, silicone gel breast implants were the most widely used products for breast augmentation and reconstruction, though saline implants also were an option.

The FDA began the approval process for silicone gel implants in the early ‘90s – the same time that anecdotal reports began to surface about women who were becoming ill, with the silicone implants cited as the cause. But there wasn’t any actual scientific evidence of the link.

“There wasn’t any data as to the safety of the implants over time,” Price said. “There wasn’t any good data showing the complication rate.”

The FDA placed a moratorium on silicone gel breast implants for augmentation purposes. To use silicone implants during the ban, surgeons had to be involved in an FDA adjunct study, in which Price, Shah and other local surgeons participated.

“They found that the implants are safe and effective,” Shah said. “With all that study and all that scientific investigation, (silicone breast implants are) probably one of the most investigated medical devices ever.”

In addition to lifting the ban, the FDA also has set requirements for additional studies to gather information about silicone implants for the next decade.

“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 Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health, in an FDA news release. “The extensive body of scientific evidence provides reasonable assurance of the benefits and risk of these devices.”

Other stipulations mandate that silicone implants can be used for breast reconstruction surgeries for women of all ages, but for breast augmentation, women must be at least 22 years old. The FDA also is recommending that patients get an MRI three years after the initial procedure and every two years thereafter.

The two companies manufacturing silicone gel implants, Allergan Corp. and Mentor Corp., also are required to register at least some of their patients in studies about the implants.

Silicone vs. saline

While silicone implants tend to have a more natural feel, they cost about twice as much as saline implants – $1,600 for a pair of silicone implants versus $800 for saline implants, Price said.

Post-operative risks for both kinds of breast implants are similar to those associated with other surgeries, including bleeding, infections and scarring.

Silicone breast implants have historically carried a much greater risk of capsular contracture – breast firmness caused by a buildup of scar tissue – and ruptures. Earlier versions of silicone implants had rupture rates as high as 70 percent within seven years, and capsular contracture in anywhere from 20 percent to 50 percent of patients, Price said.

“Like any mechanical medical device, the implants can fail,” Price said. “If a saline implant fails, it goes flat and that saline is absorbed by your body. When silicone gel implants leak, you don’t always know it.”

New silicone gel implants have a cohesive gel that doesn’t flow as did earlier versions of, so theoretically, Price said, patients who choose silicone should have fewer problems.

On the Web

For information on plastic surgery, Dr. Carl Price and Dr. Bharat Shah recommend doing research and talking with a board-certified plastic surgeon.

Suggested Web sites:

www.plasticsurgery.org

www.breastimplantsafety.org

www.fda.gov/cdrh/breastimplants