26 octobre, 2006 20:54

Health Canada and the British Study

Health Canada in there press release stated that Mentor and Inameds Implants Had Been The Most Extensively Studied Implants In Medical History And Made Reference To Studies Conducted In Britain.

I wonder if they are referring to this:

GAITHERSBURG, Md. APR 13, 2005

Mentor also pointed to about 100 women who were treated by a British surgeon and followed for 12 years. Those patients had no ruptures until at least seven years after implantation.

FDA reviewers, however, dismissed that information, noting that it included only women who wanted breast augmentation and excluded patients at higher risk of implant breakage.

If Health Canada was indeed referring to this they need to make this public, they need to release the study data.

I am going to add that this is not how a proper study is conducted and is has been made very public what is entailed in a proper study. Once again the FDA rejected this as not sufficient yet Health Canada decided it was fantastic.

The days of industry being allowed to submit there own data needs to come to an end as they will continue to always make sure it is information favourable to there product being approved.

Here is Health Canada's contact information all women need to email and ask for a copy of the study results, the transcripts from the hearings with the panel members and especially comments that were made when they put this to a vote, and each members vote.

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Mentor Wants Silicone Breast Implants Ban Lifted For Its Brand

GAITHERSBURG, Md. APR 13, 2005 (Reuters) - Mentor Corp. said on Wednesday it had stronger evidence for the durability of its silicone breast implants than a rival that failed to win a U.S. advisory panel's backing on Tuesday.

Nevertheless, Mentor appeared to face an uphill battle to end a 13-year ban on widespread sales of the devices after the Food and Drug Administration advisory panel voted 5-4 on Tuesday that Inamed Corp. did not provide a compelling case for the safety of its silicone gel-filled implants.

Shares of both companies were down more than 1 percent in morning trading.

Concerns that leaking silicone could cause disabling diseases led the FDA to ban the implants for most women in 1992.

"It's hard not to believe that the decision (on Inamed) will have an impact" on Mentor's application, said Ira Loss, who follows the FDA for Washington Analysis Corp.

The FDA will consider the advisory panel's input when deciding whether to lift the sales restrictions.

Mentor officials said they had more information about when and why implants break, as well as research showing implants improve self-confidence for women who got them to rebuild breasts after cancer surgery or others who sought bigger breasts for cosmetic reasons.

Mentor's findings "warrant deliberation that should be new and distinguished from yesterday's panel discussion," Mentor Chief Executive Josh Levine told the panel.

In a Mentor study of about 400 women, 1 percent of implants ruptured over three years. No cases of gel migrating beyond the implant were discovered.

"These implants do not tend to rupture over this period of time," said Bruce Cunningham, chairman of plastic surgery at the University of Minnesota and a Mentor consultant.

But FDA reviewers, in a summary given to panel members, said that finding was "of limited value" because patients were tracked for a short period, making it impossible to tell what would happen years later.

Mentor also pointed to about 100 women who were treated by a British surgeon and followed for 12 years. Those patients had no ruptures until at least seven years after implantation.

FDA reviewers, however, dismissed that information, noting that it included only women who wanted breast augmentation and excluded patients at higher risk of implant breakage.

Studies have failed to find a connection between silicone implants and rheumatoid arthritis, lupus and other chronic diseases that many women tie to the devices.

The implants can cause pain and other local complications, and they can break and require new operations to replace them.

Many women and plastic surgeons say silicone implants look and feel more natural than saline breast implants -- the only option for most women in the United States. Supporters say women should be able to choose silicone implants if they are fully informed of the risks.

Implant makers also say today's silicone implants are more durable than older versions, and the gel is stickier and less likely to migrate.

In the United States, only breast cancer survivors and others needing reconstruction or implant replacements can now receive silicone implants, through clinical trials.

According to the American Society of Plastic Surgeons, more than 264,000 cosmetic implant procedures and nearly 63,000 breast reconstructions were performed in 2004.

Inamed, which is being bought by Medicis Pharmaceutical Corp., said on Tuesday it will keep collecting data on its breast implants. The FDA rejected an earlier application from the company for silicone implants in January 2004.

Shares of both companies dropped in morning trading. Inamed shares were down $1.24, or 1.9 percent, at 65.17 on Nasdaq. Mentor shares were off 47 cents, or 1.3 percent, at $34.09 on the New York Stock Exchange.