Safety of Silicone Breast Implants Still Unclear: Expert Panel - Canada

[Guest guest]

Sanity is being demonstarted in Canada! . . . Rogene

===============================

http://news./s/cpress/20060113/ca_pr_on_he/health_breast_implants_2

Safety of Silicone Breast Implants Still Unclear:

Expert Panel SHERYL UBELACKER

Thu Jan 12, 9:00 PM ET

TORONTO (CP) - Health Canada should set up and

administer a registry of women with breast implants

and seek more information about the long-term safety

of the silicone-gel form of the devices, an expert

scientific panel says in its long-awaited report.

The report, made public Thursday on Health Canada's

website, will be used in part to decide if sales of

the controversial devices should be resumed in Canada.

Silicone breast implants were taken off the Canadian

market by manufacturers in 1992 - 30 years after they

were first approved - when Health Canada raised

concerns about their safety. The devices were also

removed from the U.S. market.

" Now that we've received the report, it becomes an

element of the body of evidence that needs to be

reviewed in order to make a decision as to whether or

not the gel-filled breast implants should be

authorized for sale in Canada, " Health Canada

spokeswoman Nathalie Lalonde said from Ottawa.

" We really want to make sure the decision is based on

the most information that we are possibly able to go

and get, " Lalonde said. " All that can take a bit of

time, so we're talking months here, not weeks. "

In its report, the 13-member expert panel said that

while it had received sufficient data from

manufacturers to show how the devices perform after

being implanted in a woman's body, " they do not

address all aspects of long-term safety. "

" Annual reports must be submitted that update on

ongoing studies, particularly up to 10-year followup, "

said the report to Health Canada.

Thousands of women in Canada and the United States

have joined class-action lawsuits, alleging that the

implants caused auto-immune diseases and vascular

conditions after silicone leaked into their bodies

from ruptured implants.

At a public forum in Ottawa before the panel in late

September, manufacturers Mentor Corp. and Inamed Corp.

said their new silicone implants are not only safer

(less likely to rupture or leak) than older versions,

but they offer superior breast augmentation and

reconstruction options for women compared to approved

saline implants.

However, the panel said in its report that questions

about the potential health effects of exposure to low

molecular-weight silicones had not been sufficiently

addressed, and it recommends that manufacturers be

required to demonstrate that " migrated silicone

provides acceptable risks of hypersensitivity and

auto-immunity by a critical review of company and

literature data and, if necessary, by undertaking

studies in animal models. "

While the report said that potential means of rupture

had been adequately studied, it is uncertain how long

the implants will last.

" The patient labelling should acknowledge that the

implant is not a lifetime device and that most likely

the implant will need to be replaced with subsequent

surgery, " the report said.

A national breast implant registry should be

established by Health Canada, as well as a program to

help women make an informed decision about having

silicone breast implant surgery, the panel said.

Ann Pederson of the B.C. Centre of Excellence for

Women's Health said her organization has been pushing

for years for a registry that would track women with

breast implants to see if the devices are indeed safe

over time.

" Obviously, we're delighted that the panel has

recommended the establishment of a breast implant

registry and they've suggested that Health Canada be

responsible for that, " Pederson said from Vancouver.

" I think that's very, very positive, because that will

allow us to continue to gather evidence to answer some

of the questions that the panel was not charged with

asking, but which are part of the larger domain of

concern with regard to the safety and efficacy of

breast implants. "

Lalonde said a registry is one way to " mitigate the

risk. "

" And we're certainly going to look at that

possibility. It's not the only way to mitigate the

risk. We need to look at all the options before a

decision is made. "

The panel also had concerns about information provided

to patients about the devices, saying the product

should come with information - and it should also be

available to patients considering the surgery in both

printed material and via the Internet.

Labelling of the product should include warnings about

possible contraindications, the report said.

" Patients presenting with depression and/or an eating

disorder, if untreated, should be referred for

treatment before considering breast augmentation

surgery. If they are in treatment, communication

between the plastic surgeon and the treating mental

health professional is strongly recommended.

" Although no causal link was established between

breast augmentation surgery and suicide, patients with

psychiatric disorders such as depression and eating

disorders should postpone the decision for breast

augmentation until the complete resolution of the

depression and/or the eating disorder. "

The panel also " strongly " advised Health Canada that

only Royal College-certified plastic surgeons,

specifically trained, be allowed to implant the

devices.

-

On the Net:

Health Canada: http://www.hc-sc.gc.ca/index-e.html