Key panel backs return of silicone breast implants

WASHINGTON — A sharply divided panel of outside experts recommended Wednesday that the government permit general use of silicone gel implants for breast enhancement, a decision that would reverse a decade-old restriction triggered by widespread reports of serious side effects.

The committee voted 9 to 6 in favor of resuming use of the implants after the majority concluded that the health risks were not significant enough to keep the popular implants off the market.

The panel’s recommendation, which followed two days of public hearings, is not binding on the Food and Drug Administration. The agency usually follows the lead of its advisory groups, but FDA officials said the divided verdict would make the decision more difficult than usual.

Panel members unanimously voiced concern over the lack of long-term data on the health risks, but the majority concluded that the best available studies showed they were acceptable. The evidence on both sides has long been the subject of intense controversy, with critics saying the implants caused serious health problems for thousands of women, while manufacturers and plastic surgeons said the risks had been exaggerated and were not supported by good research.

The panel’s recommendation could open the door to general use of the implants 11 years after the FDA limited their use to women who had undergone mastectomies or took part in clinical studies. That left implants filled with saline solution as the only product approved for general use.

If the FDA accepts the recommendation, plastic surgeons said during two days of hearings, many of the 1 million women expected to seek implants over the next three years will probably choose the silicone version, which women tend to prefer on the grounds that they look and feel more natural.

The recommendation was tied to conditions that would require the implant maker, Inamed Corp. of Santa Barbara, Calif., to set up a program to retrain surgeons in the use of the devices, create a registry of implant users and hire an outside group to oversee it, and extend its studies of implant users for as many as 10 years. Inamed would also have to develop a model informed consent form in conjunction with the FDA and panel members.

Implant critics, who spoke emotionally and at length during the hearing, said they were dismayed.

"It was a split vote, and all the plastic surgeons on the panel were for it," said Diana Zuckerman of the National Center for Policy Research for Women and Families. "There were too many people involved with a conflict of interest."

The 1992 decision to restrict the use of silicone implants was based largely on widespread complaints that they triggered neurological or connective tissue disorders such as arthritis, lupus erythematosus or fibromyalgia. But in 1999, the federally chartered Institute of Medicine reviewed all the available studies and concluded there was no evidence that silicone implants were causing serious disease.

But in the hearing, Inamed presented data showing that significantly more women with implants complained of joint pain, fatigue and similar conditions two years after receiving the implants. Asked whether the company’s data had reopened the issue of connective tissue disorders, Sahar Dawisha, the FDA medical officer who reviewed the data, said, "The issue is not resolved at this time."

But Caroline Glickman, a plastic surgeon at Memorial Sloan-Kettering Cancer Center in New York, said: "Men have the right to choose Viagra even if they have a risk of heart disease. Women have the right to make a choice like that, too, with silicone implants."

Talk to us

More in Local News

Emergency responders surround an ultralight airplane that crashed Friday, Sept. 22, 2023, at the Arlington Municipal Airport in Arlington, Washington, resulting in the pilot's death. (Ryan Berry / The Herald)
Pilot dead in ultralight plane crash at Arlington Municipal Airport

There were no other injuries or fatalities reported, a city spokesperson said.

An example of the Malicious Women Co. products (left) vs. the Malicious Mermaid's products (right). (U.S. District Court in Florida)
Judge: Cheeky candle copycat must pay Snohomish company over $800K

The owner of the Malicious Women Co. doesn’t expect to receive any money from the Malicious Mermaid, a Florida-based copycat.

A grave marker for Blaze the horse. (Photo provided)
After Darrington woman’s horse died, she didn’t know what to do

Sidney Montooth boarded her horse Blaze. When he died, she was “a wreck” — and at a loss as to what to do with his remains.

A fatal accident the afternoon of Dec. 18 near Clinton ended with one of the cars involved bursting into flames. The driver of the fully engulfed car was outside of the vehicle by the time first responders arrived at the scene. (Whidbey News-Times/Submitted photo)
Driver sentenced in 2021 crash that killed Everett couple

Danielle Cruz, formerly of Lynnwood, gets 17½ years in prison. She was impaired by drugs when she caused the crash that killed Sharon Gamble and Kenneth Weikle.

A person walks out of the Everett Clinic on Thursday, Sept. 7, 2023 in Everett, Washington. (Olivia Vanni / The Herald)
The Everett Clinic changing name to parent company Optum in 2024

The parent company says the name change will not affect quality of care for patients in Snohomish County.

Tirhas Tesfatsion (GoFundMe) 20210727
Lynnwood settles for $1.7 million after 2021 suicide at city jail

Jail staff reportedly committed 16 safety check violations before they found Tirhas Tesfatsion, 47, unresponsive in her cell.

William Gore, left, holds the hand of Skylar, 9, in a Baby Yoda sweatshirt as they go for a walk in the rain at Forest Park on Monday, Sept. 25, 2023 in Everett, Washington. (Olivia Vanni / The Herald)
Keep your umbrellas, rain gear handy this week in Snohomish County

The National Weather Service says up to 1½ inches are possible through Wednesday.

The city of Mukilteo is having a naming contest for its new $75,000 RC Mowers R-52, a remote-operated robotic mower. (Submitted photo)
Mukilteo muncher: Name the $75,000 robot mower

The city is having a naming contest for its new sod-slaying, hedge-hogging, forest-clumping, Mr-mow-it-all.

In this photo posted to the Washington state Department of Ecology website and taken by the U.S. Coast Guard, people watch as emergency crews respond to the Walla Walla passenger ferry, which ran aground near Bainbridge Island west of Seattle, Saturday, April 15, 2023. (Lt. Cmdr. Brian Dykens/U.S. Coast Guard via AP)
Edmonds-Kingston shuffle: 64-car ferry replaces 202-car boat, for now

The system-wide boat swap stems from the vessel Walla Walla out of service for four weeks for repairs.

Most Read