Fw: Update on THE BREAST IMPLANT RESEARCH AND INFORMATION ACT

[Guest guest]

From: " Ilena Rose " <ilena@...>

Sent: Tuesday, August 28, 2001 12:25 PM

Subject: Update on THE BREAST IMPLANT RESEARCH AND INFORMATION ACT

> From: " Toxic Discovery Network " <toxicdiscovery@...>

>

> --------------------------------------------

> The update list of House and Senate co-sponsors can be accessed through

> thomas.loc.gov, the Library of Congress' website for legislation. Women

> should know that when the Congress is out of session, names of new

> co-sponsors cannot be added until they are back in session, which will be

on

> September 4. The House bill is HR 1961 and the Senate bill is S 961.

Here

> is the overview of what the legislation will accomplish:

> THE BREAST IMPLANT RESEARCH AND INFORMATION ACT

>

> More than 200,000 women receive breast implants each year, and once again

> controversy is swirling around this issue of their safety. Last year, the

> Food and Drug Administration approved saline breast implants in spite of

> data from the manufacturers showing, among other findings, that 73% of

> mastectomy patients reported severe complications within 3 years. Dr. S.

> Lori Brown recently released a study showing that women whose silicone gel

> implants had ruptured and leaked were twice as likely to report having

> fibromyalgia as women whose implants had not ruptured. Dr. Louise Brinton,

> an epidemiologist at the National Cancer Institute, found an increased

risk

> of brain and lung cancer among implant recipients when compared to other

> plastic surgery patients.

>

> Reps. Roy Blunt (R-MO) and Gene Green (D-TX) have introduced H.R. 1961,

AThe

> Breast Implant Research and Information Act@ in the House; along with

> Senator Barbara Boxer (D-CA), who introduced S. 961 in the Senate. By

> addressing the need for more independent research and greater FDA

oversight,

> the legislation will give women the information necessary to make informed

> choices about implants.

>

> The Breast Implant Research and Information Act consists of three major

> components:

>

> I. Expand NIH Research on Breast Implants

>

> The bill directs NIH to conduct independent, scientifically valid research

> on both saline and silicone breast implants. The need for such research is

> clear:

>

> _ To date, most research on breast implants has been funded by implant

> manufacturers;

>

> _ Many studies have been methodologically flawed, combining women with

> saline and silicone implants, mastectomy patients with cosmetic

augmentation

> patients, and women who have had implants in excess of 10 years with those

> who have had them for only three months;

>

> _ There has NEVER been a large-scale study focusing exclusively mastectomy

> patients and the long-term effect of implants on their health.

>

> II. Strengthen Post Market Surveillance Activities Related to Saline

> Implants at the FDA

>

> The FDA is instructed to conduct post-market evaluations of saline

implants,

> acting on recommendations made by the FDA=s General and Plastic Surgery

> Devices Panel. Strong FDA oversight is especially important given the

> circumstances surround the approval of saline implants:

>

> _ As noted above, 73% of mastectomy patients reported serious local

> complications following implantation. Complications included rupture,

> hardening, infection and chronic pain;

>

> _ With studies lasting only 3 years, the long term effect of saline

implants

> is unknown;

>

> _ At the time of approval, the FDA was conducting a criminal investigation

> into one of the implant manufacturers related to allegations of data

> manipulation in its breast implant trials. This investigation remains

open.

>

> III. Expand and Intensify FDA Activities Relating to Silicone Breast

> Implants

>

> The Commissioner of the FDA is directed to take concrete steps to ensure

> that women, particularly those participating in clinical trials of

silicone

> implants, have accurate, current information about implants. Greater FDA

> involvement is essential because:

>

> _ Informed consent agreements are written by implant manufacturers;

>

> _ Informed consent agreements and package inserts prepared by

manufacturers

> have been shown to include outdated, inaccurate information;

>

> _ Women involved in clinical trials have had difficulty in reporting

> problems with their implants and with the trials themselves.

>

> The Breast Implant Research and Information Act is critical if women are

to

> fully understand the impact of breast implants on their health.

>

>

>