U.S. government lifts its 14-year ban on silicone-gel breast implants: Knowledge Driven Revolution

Related - Silicone gel breast implants approved for return to Canadian market

The U.S. government ended a 14-year virtual ban on silicone-gel breast implants Friday, despite lingering safety questions, making the devices available to tens of thousands of women who have clamoured for them.

The Food and Drug Administration approved the implants for women 22 and older, or those having breast-reconstruction surgery but warned patients probably would need at least one additional operation because the implants don't last a lifetime.

The decision clears implants made by two California manufacturers, Inamed Corp. - now part of Allergan Inc. - and Mentor Corp.

"There is reasonable assurance that Allergan and Mentor silicone-gel breast implants are safe and effective and there is adequate information to enable women to make informed decisions," said Dr. Daniel Schultz, the FDA's medical device chief.

Mentor called the decision an "historic moment." Allergan said it created new options for women.

However, Dr. Sidney Wolfe, a longtime opponent, called the implants "the most defective medical device FDA has ever approved."

And a legislator called on Congress to investigate the FDA's approval process.

The twin approvals came with conditions, including a requirement that the companies complete 10-year studies on women who have already received the implants to study leaks, as well as begin new decade-long studies of the safety of the devices in 40,000 women. The FDA set the age minimum because women's breasts aren't fully developed before then.

Health Canada announced last month it had issued licences to Mentor and Allergan to make the approved products.

The manufacturers had to agree to continue a long-term study of the safety of the implants and to develop new product labelling after holding focus group sessions with Canadian doctors and women who have the devices implanted.

Schultz called the implants "one of the most extensively studied medical devices."

The FDA warned the implants are not without risk and women may not immediately know if their implants break. That means women with the implants will need regular MRIs to catch those so-called "silent ruptures." Such MRIs typically cost several hundred dollars - a cost not always covered by insurance.

Patients will have to be given special brochures that explain these risks.

The FDA decision opens the implants to much wider use by women seeking to reconstruct or augment their breasts. Since 1992, the silicone implants had been available only as part of research studies.

Silicone-gel breast implants first went on the market in 1962, before the FDA required proof all medical devices be safe and effective. Thirty years later, they were banned amid concerns about their safety.

At the time, there were worries about a possible connection to a variety of diseases, including cancer and lupus. Alarming cases of ruptures added to the concern.

Since then, most studies have failed to find a link between silicone breast implants and disease.

The rupture issue persists. An Institute of Medicine report in 2000 found rupture rates as high as 77 per cent. The FDA's Dr. Donna-Bea Tillman said women should expect them to last for the "reasonably foreseeable future," without elaborating.

U.S. Representative Rosa DeLauro, a Connecticut Democrat, called on Congress to investigate the FDA's decision-making process to make sure it is "based on science and not on corporate and political considerations."

"From a scientific standpoint, the decision we are making tonight is in the best interests of American women," Schultz responded.

Women whose silicone implants ruptured have reported years of pain, swelling, numbness and other symptoms they blame on the devices. Leaked silicone gel can migrate throughout the body, forming lumps. Implants also can cause infection and form hard, painful scar tissue that can distort the shape of a breast.

Some researchers also worry the platinum used to manufacture the implants can seep into the body and cause harm. The FDA said there is no evidence of that.

Proponents said silicone-gel implants look and feel more natural than do those filled with saline, or salt water. Those implants are sold without restrictions.

"It's a hugely positive piece of news for plastic surgeons and for patients and for the company - all three - 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," said Dr. Scott Spear, head of plastic surgery at Georgetown University Hospital and an Allergan consultant.

Last year, the FDA told both companies their implants could be approved once they met additional, undisclosed conditions. Federal advisers had narrowly recommended Inamed's implants not receive FDA approval, citing concerns about the long-term durability. The same advisers endorsed Mentor's implants.

In October 2003, FDA advisers had recommended allowing the implants to be sold again. The agency overruled that recommendation.

Breast implants have become more popular, despite a history of lawsuits. Last year, 291,000 women had their breasts surgically enlarged in the United States, a 37-per-cent increase since 2000, the American Society of Plastic Surgeons said.

The popularity of implants for reconstructive surgery shrank over the same five-year period by 29 per cent, to 58,000 procedures, Society statistics showed. Last year, 39,000 women had their implants removed.

Overall, the use of breast implants has grown since 1992, despite the FDA's de facto ban on silicone-gel implants.

Just three years later, Dow Corning Corp., once the major manufacturer of silicone breast and other implants, faced 19,000 lawsuits, pushing it into bankruptcy protection in 1995. The company emerged from that status in 2004, after setting aside US$2.35 billion to settle claims.

Allergan Inc. shares rose by $1.76, or 1.6 per cent, in trading that was almost double its average volume to close at $112.50 on the New York Stock Exchange. Mentor Corp. shares increased by $1.47, or 3.19 per cent, also in heavy trading, closing at $47.58.

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HOME Rouge States and the 9/11 Truth Terrorists Canadians Should Pay NOT to be Poisoned: NDP V for Vendetta - R for Reality Canadian Bird Flu Pandemic Looming ? Shill of the Week: Stephan Harper Aspartame: The Sweetest Killer Chicken Little Terrorist of the Week: Creating Fake Terrorists Shill of the Week: Paul Martin The Number 1 Reason YOU became a Slave	U.S. government lifts its 14-year ban on silicone-gel breast implants CP November 20, 2006 Related - Silicone gel breast implants approved for return to Canadian market The U.S. government ended a 14-year virtual ban on silicone-gel breast implants Friday, despite lingering safety questions, making the devices available to tens of thousands of women who have clamoured for them. The Food and Drug Administration approved the implants for women 22 and older, or those having breast-reconstruction surgery but warned patients probably would need at least one additional operation because the implants don't last a lifetime. The decision clears implants made by two California manufacturers, Inamed Corp. - now part of Allergan Inc. - and Mentor Corp. "There is reasonable assurance that Allergan and Mentor silicone-gel breast implants are safe and effective and there is adequate information to enable women to make informed decisions," said Dr. Daniel Schultz, the FDA's medical device chief. Mentor called the decision an "historic moment." Allergan said it created new options for women. However, Dr. Sidney Wolfe, a longtime opponent, called the implants "the most defective medical device FDA has ever approved." And a legislator called on Congress to investigate the FDA's approval process. The twin approvals came with conditions, including a requirement that the companies complete 10-year studies on women who have already received the implants to study leaks, as well as begin new decade-long studies of the safety of the devices in 40,000 women. The FDA set the age minimum because women's breasts aren't fully developed before then. Health Canada announced last month it had issued licences to Mentor and Allergan to make the approved products. The manufacturers had to agree to continue a long-term study of the safety of the implants and to develop new product labelling after holding focus group sessions with Canadian doctors and women who have the devices implanted. Schultz called the implants "one of the most extensively studied medical devices." The FDA warned the implants are not without risk and women may not immediately know if their implants break. That means women with the implants will need regular MRIs to catch those so-called "silent ruptures." Such MRIs typically cost several hundred dollars - a cost not always covered by insurance. Patients will have to be given special brochures that explain these risks. The FDA decision opens the implants to much wider use by women seeking to reconstruct or augment their breasts. Since 1992, the silicone implants had been available only as part of research studies. Silicone-gel breast implants first went on the market in 1962, before the FDA required proof all medical devices be safe and effective. Thirty years later, they were banned amid concerns about their safety. At the time, there were worries about a possible connection to a variety of diseases, including cancer and lupus. Alarming cases of ruptures added to the concern. Since then, most studies have failed to find a link between silicone breast implants and disease. The rupture issue persists. An Institute of Medicine report in 2000 found rupture rates as high as 77 per cent. The FDA's Dr. Donna-Bea Tillman said women should expect them to last for the "reasonably foreseeable future," without elaborating. U.S. Representative Rosa DeLauro, a Connecticut Democrat, called on Congress to investigate the FDA's decision-making process to make sure it is "based on science and not on corporate and political considerations." "From a scientific standpoint, the decision we are making tonight is in the best interests of American women," Schultz responded. Women whose silicone implants ruptured have reported years of pain, swelling, numbness and other symptoms they blame on the devices. Leaked silicone gel can migrate throughout the body, forming lumps. Implants also can cause infection and form hard, painful scar tissue that can distort the shape of a breast. Some researchers also worry the platinum used to manufacture the implants can seep into the body and cause harm. The FDA said there is no evidence of that. Proponents said silicone-gel implants look and feel more natural than do those filled with saline, or salt water. Those implants are sold without restrictions. "It's a hugely positive piece of news for plastic surgeons and for patients and for the company - all three - 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," said Dr. Scott Spear, head of plastic surgery at Georgetown University Hospital and an Allergan consultant. Last year, the FDA told both companies their implants could be approved once they met additional, undisclosed conditions. Federal advisers had narrowly recommended Inamed's implants not receive FDA approval, citing concerns about the long-term durability. The same advisers endorsed Mentor's implants. In October 2003, FDA advisers had recommended allowing the implants to be sold again. The agency overruled that recommendation. Breast implants have become more popular, despite a history of lawsuits. Last year, 291,000 women had their breasts surgically enlarged in the United States, a 37-per-cent increase since 2000, the American Society of Plastic Surgeons said. The popularity of implants for reconstructive surgery shrank over the same five-year period by 29 per cent, to 58,000 procedures, Society statistics showed. Last year, 39,000 women had their implants removed. Overall, the use of breast implants has grown since 1992, despite the FDA's de facto ban on silicone-gel implants. Just three years later, Dow Corning Corp., once the major manufacturer of silicone breast and other implants, faced 19,000 lawsuits, pushing it into bankruptcy protection in 1995. The company emerged from that status in 2004, after setting aside US$2.35 billion to settle claims. Allergan Inc. shares rose by $1.76, or 1.6 per cent, in trading that was almost double its average volume to close at $112.50 on the New York Stock Exchange. Mentor Corp. shares increased by $1.47, or 3.19 per cent, also in heavy trading, closing at $47.58. Read the full article here Broken Link? If the link to the original article is broken or has been altered you can view the article by clicking here. About KDR \| \| Home \| \| Weekly Features Archive	Weekly Features Archive
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