U.S. Ends Ban on Silicone Breast Implants

STEPHANIE SAUL / New York Times 17nov2006

[More on Breast Implants]

The Food and Drug Administration yesterday lifted a 14-year ban on the use of silicone gel breast implants in the United States following a many years of debate over their safety.

The federal agency approved implants manufactured by two California companies, Mentor and Allergan, both for breast reconstruction and for cosmetic breast augmentation. But the agency restricted cosmetic use of the implants to women aged 22 and older.

Because the implants containing silicone gel are softer than saline implants currently available, plastic surgeons said they would quickly become preferred among the more than 300,000 women in this country who have breast implants each year.

Supporters of the implants, including leading surgeons, applauded the decision.

“For us, it’s a triumph of science,” said Dr. Richard A. D’Amico, president-elect of the American Society of Plastic Surgeons. “We’ve always felt that the science would bear out the use of the implants.”

Dr. Daniel G. Schultz, director of the agency’s Center for Devices and Radiological Safety, said that the agency’s review, based on company-sponsored studies as well as long use of the implants abroad, had shown they are safe.

But he warned that no device is foolproof, and there is a possibility that women will need to have the implants replaced at some point, sometimes because they rupture.

“Women should know that breast implants are not lifetime devices,” he said in a telephone briefing for reporters last evening. “Women having these procedures done need to be prepared for the fact that there is a likelihood they will require additional surgery,” he said.

He also recommended regular screening MRIs to monitor the devices for “silent rupture,” beginning three years after their implants.

Critics of the agency said yesterday that the approval should not have been granted, citing safety concerns.

Dr. Sidney Wolfe, chief of Public Citizen’s Health Research Group, called the implants “the most defective medical device ever approved by the F.D.A. The approval makes a mockery of the legal standard that requires ‘reasonable assurance of safety.’ ”

Defending the decision, Dr. Schultz said, “We have been looking at this data continuously for the last 10 years. We have been watching as data had been collected, we have been watching as data has accumulated. We believe that from a scientific standpoint, the decision that we’re making tonight is, in fact, in the best interest of American women.”

But he said the agency would require the companies each to conduct a large post-approval study of 40,000 women to continue monitoring safety of the devices. He said that information would be collected about rates of rupture, rates of cancer and autoimmune diseases and effects of the implants on reproduction, among other data. That would enable the agency to evaluate concerns about the implants in a large number of women.

The agency approved the devices for all women for reconstruction following breast cancer, trauma, or in the case of women with developmental disorders affecting the chest. But the agency said that they would not be available to women under 22 years old for cosmetic use.

“We wanted to make sure that breast development had been completed before these devices had been implanted,” Dr. Schultz said, adding that the agency also did not have clinical data on younger women. “We concluded that age 22 was the appropriate age for the lower limit for augmentation.”

Silicone breast implants were never officially approved in the United States but were available under a grandfather provision allowing the use of medical devices. Following complaints in the 1980s and 1990s that women developed cancer and autoimmune diseases as a result of ruptured implants, silicone implant makers were forced to take their products off the United States market in 1991, except for treating mastectomy patients and some other special cases and only when the patients were enrolled in clinical studies.

In 1999, the Institute of Medicine, an arm of the National Academic of Sciences, said there was no definitive evidence that silicone implants were associated with connective tissue disease or cancer.

Dr. Scott L. Spear, the chief of plastic surgery at Georgetown University who has conducted clinical research for Allergan, said the devices have been improved since the early 1990s.

“The shells themselves are made of different materials, a barrier shell, that is relatively much more impermeable,” Dr. Spear said. “The shells are thicker than in ‘91, much thicker than they were in earlier generations. The material inside is more cohesive, the stuff tends to stick together.”

Canadian regulators cleared the implants for sale and implantation in October.

source: 17nov2006

US Lifts Ban on Silicone Implants

BBC 18nov2006

Health authorities in the US have lifted a 14-year-long ban on silicone breast implants. Despite lingering safety concerns, two firms will be allowed to sell implants to women reconstructing or enlarging their breasts.

Each company will be required to study the effect of the implants on 40,000 women for 10 years.

Silicone breast implants were banned for most American women in 1992 after complaints that the devices leaked.

There were accusations that leaking silicone made some women ill.

But the Food and Drug Administration said independent studies had found no evidence that silicone implants caused cancer or other diseases.

However, it said there was still a risk of complications such as breast pain and implant rupture.

Implant lifespan

Patients and surgeons who advocate silicone breast implants say they look and feel more natural than those filled with salt water.

But since 1992 they have only been available to women through research programmes.

Concerns over the potential lifespan of the implants still lingers though, with the FDA warning that many silicone implants will eventually need to be removed or replaced.

"It's a hugely positive piece of news for plastic surgeons and for patients... because it really allows us to turn a page and to work with what we have believed for a long time is a better technology and better device," Dr Scott Spear, head of plastic surgery at Georgetown University Hospital told the Associated Press.

source: http://news.bbc.co.uk/2/hi/americas/6160432.stm 17nov2006

Health Canada Approves Use of Silicone-Gel Breast Implants

Decision comes after 14-year moratorium on surgical use of controversial product

UNNATI GANDHI / Globe and Mail (Toronto, Canada) 17nov2006

Canadian women will no longer have to jump through licensing loopholes to get silicone-gel breast implants after the government lifted a 14-year moratorium on the product yesterday.

But while many doctors and patients are elated by the news, others fear the implants are still dangerously unsafe, bringing the decades-old controversy full-circle.

Health Canada said it reviewed more than 65,000 pages of documents and cited comprehensive studies from Britain and the United States before concluding there was no evidence that silicone implants cause auto-immune diseases or other systemic illnesses. It was these very concerns that led the government in 1992 to partially ban the gel-filled implants. Only saline-filled ones have been widely available here since then.

"I think it's safe to say that these medical devices are the most intensively studied medical devices in medical history," said Supriya Sharma, associate director-general of the therapeutic products directorate for Health Canada.

One of the country's leading authorities on dangerous chemicals in women concurs that silicone breast implants are safe.

"Study after study has shown there's no apparent risk," said Gideon Koren, director of Motherisk at Toronto's Hospital for Sick Children. "So, we should not be orphaning women from things they need."

The licences granted to Inamed Corp. and Mentor Medical Systems are conditional, and require the manufacturers to continue to provide data for at least 10 years from a continuing clinical trial, as well as launch within one year another long-term study involving tens of thousands of women to look for rare side effects.

But news that long-term studies haven't concluded yet has at least one implant patient worried.

"This should have been done before they allowed them onto the market, [instead of] playing this game of roulette with women's lives," said Joyce Attis, president and founder of the Breast Implant Line of Canada and the lead plaintiff in a pending class-action lawsuit against Health Canada.

"It takes years before these implants can make you sick. Yet the studies Health Canada has relied upon are not of a long enough duration . . . and they're allowing this poison back on the market."

In 1972, Ms. Attis had a cohesive silicone prosthetic inserted because her right breast had never developed. She was 21 at the time and she "just wanted to be able to wear clothes properly and have breasts of equal size."

But by the late 1970s, her implanted breast had hardened and she was suffering from excruciating rib and back pain. The doctors couldn't diagnose her, and one even inserted a steel rod into her spine to ease the chronic pain.

Ten years later, doctors discovered silicone under her breasts, and around her rib cage to her spine.

"They were scraping the silicone gel off," said Ms. Attis, 55, who now suffers from fibromyalgia, lupus syndrome and osteoporosis, and knows of many other women with implants suffering from adverse effects.

In the 1990s, manufacturer Dow Corning paid out $2.35-billion (U.S.) to settle class-action lawsuits involving more than 300,000 women, including some from Canada, who said their health was harmed by the devices.

This year, the safety of gel implants was again brought into question when a significant Canadian study reported a 73-per-cent higher rate of suicide among women with breast implants than the general population.

And just last week, new allegations arose in the United States that Mentor misrepresented safety data for its gel breast implants. The scientist at the company who made the allegations was fired and he provided the information to the Food and Drug Administration. An investigation is under way.

But despite the controversy, plastic surgeons are wondering how much of an impact the new licences will have in a country where 200,000 women have had breast implants. Gel-filled implants have been available in Canada since the 1992 moratorium through Health Canada's special access program, under which doctors have to certify that suitable alternative procedures are not available.

According to one cosmetic surgeon, the application process was nothing more than a small hindrance, because everyone who applied was approved.

"[It] was virtually a rubber stamp, because it was seldom declined," said Peter Wyshynski, who has a plastic surgery practice in Waterloo, Ont.

"They were approved both for reconstruction after cancer, or injuries, or diseases of the breast, but they were also approved for cosmetic purposes."

A Health Canada official confirmed that there have been no refusals of special access program requests for silicone implants since December of 2004, and that an average of 8,000 cases are approved every year.

source: 17nov2006