Breast Implants Public Forum - September 29 & 30 in Ottawa

[Guest guest]

Health Canada has invited individuals and organizations to comment on

the safety, risks and benefits of silicone gel-filled breast implants

that are currently under review by Health Canada.

To register to be part of this public consultation process, and for

more details, please visit:

http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/sci-consult/implant-

breast-mammaire/implants_e.html

Note: DEADLINE FOR REGISTRATION IS SEPTEMBER 9, 2005.

~~~~~~~~

http://www.cwhn.ca

Breast Implants Public Forum - Welcome!

Welcome to Health Canada's web page for the public forum on silicone

gel-filled breast implants. On this site you will find information

about the input process and how you can contribute to Health

Canada's decision-making.

Health Canada is currently assessing license applications to sell

silicone gel-filled breast implants in Canada. Currently, only

saline-filled breast implants are licensed for sale in Canada.

The Canadian review of the license applications for silicone gel-

filled breast implants has not been completed to date. Health Canada

is taking a phased approach to reviewing and assessing these license

applications, with public input being an integral part of Health

Canada's decision-making process. In the first phase, a Scientific

Advisory Panel was convened on March 22-23, 2005 to consider

questions posed to them by Health Canada on emerging issues related

to the safety and effectiveness of silicone gel-filled breast

implants.

The second phase of the review will include a public component.

Health Canada is convening an expanded panel including members who

are consumers and patient experts, in Ottawa on September 29 and 30,

2005, to bring a broader perspective to the issues. In addition, the

expanded Expert Advisory Panel will hear presentations from

stakeholders, patient groups, consumers and members of the public

during a time set aside specifically for public input. The public is

also able to make their views known to the panel by sending their

input online or by mail or fax.

Please note the following important deadline: The last day to

register to present in person to the Expert Advisory Panel is

Friday, September 9, 2005. All the written and on-line input

received at that date will be submitted to the Panel members. You

are welcome to provide input past September 9th so it can be shared

with others on the website. This information will be reviewed on-

line by the Panel members at their discretion. "

Observe the meeting

View what others are saying:

On-Line Public Input

Public Presentation Synopses

Provide Input

Get the results

The Chair who presided at the March 2005 Scientific Advisory Panel,

Wells, PhD, Msc of the University of Ottawa will also chair

the expanded panel and its public forum component. Dr. Wells will

then roll-up the advice from both events into a single report to

Health Canada. The Department will subsequently weigh all the

evidence and take a regulatory decision on the safety and efficacy

of the products under consideration.

Seeking advice from an advisory panel is a regular part of decision-

making and risk management processes at Health Canada and at other

regulatory agencies around the world. Panels convened by Health

Canada generally review up-to-date data and evidence on a particular

subject, meet to hear presentations on the subject, and then

deliberate in the context of questions posed to them by the

Department. The result of a panel's deliberations takes the form of

advice that is given to Health Canada in support of its regulatory

decision-making.

When a public forum is added to a meeting of an advisory panel, it

includes having a time to hear presentations to the Expert Advisory

Panel and to make views known to the Panel during a time set aside

specifically for public input. This is a relatively new practice for

the Department. Health Canada is committed to openness and

transparency in its decision-making and as we progress towards that

goal, we welcome your feedback.

The Expert Advisory Panel on breast implants will meet at the Westin

Hotel, 11 Colonel By Drive in Ottawa on September 29 and 30, 2005 to

hear presentations from the manufacturers and members of the general

public and to consider specific questions that relate to the safety

and efficacy of the devices being discussed. There will be

presentations from Health Canada and industry representatives and

input from the public can be provided in person by mail or fax in

advance of the forum.

The public is also invited to attend the public portion of the

meeting to hear presentations from Health Canada and the industry.

The Panel will meet in private after the public forum to review

confidential commercial data and deliberate on what advice to give

Health Canada. This private portion of the Panel meeting is

necessary in order to protect the confidentiality of some commercial

information provided to the Department by the manufacturers of these

products.

Exact times for the public portion of the meeting will be made

public in the weeks to come.