Fw: Update on Saline Breast Implants

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----- Original Message -----

From: " Kathi " <pureheart@...>

Sent: Tuesday, October 01, 2002 6:37 PM

Subject: Update on Saline Breast Implants

> >From The Network News (a nursing newsletter) . . September/October 2002

> =================================

> Update on Saline Breast Implants

>

> by Zuckerman, Ph.D.

>

> On July 9, 2002, an FDA panel expressed deep concern about the risks of

> breast implants and about the lack of safety data.

>

> The meeting was requested by an FDA advisory panel that had recommended

> FDA

> approval of saline implants in 2000 under the condition that the

> companies,

> Mentor and lnamed (formerly McGhan), conduct long-term safety studies.

> Both

> companies provided at least five years of safety data at the meeting.

> However, of the more than 1,200 women in the Men-tor study, only 60 (5

> percent!) were ana-lyzed at the five-year follow-up. Panel members said

> an

> informed choice was impossible for Mentor patients because of the tow

> response rate. The concern is that women who dropped out of the study

> may

> have very different medical problems from those who participated.

>

> The lnamed/McGhan data were better designed but showed extremely high

> complication and re-operation rates. For example, during the first five

> years of having implants, 45 percent of breast cancer reconstruction

> patients required additional unplanned surgery, 28 per-cent had their

> implants removed, 39 per. cent had breasts that did not match in

> appearance,

> 36 percent had capsular contracture (hardness), 27 percent had implants

> that

> were visible or could be felt, 25 percent had implants that created a

> wrinkling appearance, 18 percent had implants that had moved to the

> wrong

> location, 18 percent had breast pain, and 8 percent had implants that

> leaked

> or deflated. The rates of 10 other compli-cations such as infections,

> skin

> necrosis (skin death) and implants extruding through the skin ranged

> from 3

> to 7 per-cent each.

>

> There are other reasons to be concerned about the safety of breast

> implants.

> Four members of Congress recently asked FDA about their criminal

> investigation of Mentor. FDA says they cannot discuss the probe

> publicly.

> Two members also asked FDA to provide the advisory panel with studies

> conducted by the National Cancer Institute: one showed an increased risk

> of

> cancer for women with saline or silicone implants compared to other

> women,

> and the other showed an increased risk of deaths from brain cancer and

> lung

> diseases. Many of us wondered why FDA did not provide the data or

> mention

> the studies, even though one of their own scientists helped conduct the

> research.

>

> The bottom line: more than 250,000 women underwent implant surgery last

> year, more than 200,000 of them to increase the size of their healthy

> breasts. At the same time, 60,000 had their implants removed. Almost 40

> years after silicone breast implants were invented, we still know very

> little about their long-term safety.

>

> Zuckerman, Ph.D., is a former member of the Network's Board and

> the

> President of the National Center for Policy Research for Women &

> Families, a

> non-profit think tank and advocacy organiza-tion. More information is

> available at www.center4policy.org.

>

>

>