children breastfed by women w/breast implants study

[Guest guest]

CHILDREN BREASTFED BY WOMEN WITH BREAST IMPLANTS

FDA is receiving inquiries about a preliminary study

reported in the Jan. 19 Journal of the American Medical

Association suggesting that breastfed children of women with

silicone gel breast implants may be at risk of developing

abnormal esophageal motility. This is a reduction in the normal

wave-like motion of the esophagus that moves food toward the

stomach. FDA believes that the study is inconclusive and

preliminary, and further studies are needed before any

conclusions should be drawn from it.

Abnormal esophageal motility is seen in a number of other

disorders, but often appears in children with systemic sclerosis,

an autoimmune disease. There have been allegations that leaking

silicone could cause autoimmune diseases.

The study evaluated 11 children between one and a half and

13 years old with chronic gastrointestinal problems, who had been

born to women with silicone breast implants. The problems

experienced by these children included abdominal pain with at

least one of the following: vomiting, difficulty in swallowing or

poor weight gain.

Eight of the 11 children had been breastfed, while the

remaining three children had been exclusively bottle fed. Six of

these eight breastfed children had significantly abnormal lower

esophageal motility compared with the three bottle fed children

and with another group of children whose mothers did not have

breast implants.

Based on these results, the authors state that a

relationship may exist between breastfeeding by some mothers with

silicone implants and abnormal esophageal motility in their

children. The authors suggest this may occur through the

mother's " immunologic factors " transmitted through the breast

milk or through substances leaking from the implant. However,

they acknowledge that further study is needed before definite

conclusions can be drawn. An editorial published in the same

issue cautions that these results have not been confirmed.

FDA had been aware that this study was in progress, based on

information previously presented by these authors at a scientific

meeting. The agency views this study with interest, but the

limitations of the study design including, for example, the small

size of the study and selection bias, limit conclusions that can

be drawn from it.

FDA agrees with the study's conclusion that more research is

needed. The agency is encouraged that physicians are taking

patient complaints seriously and that they are pursuing further

research.

There is no widely available, standardized test to detect

silicone in the body. Some large, sophisticated research

laboratories are able to detect the presence of silicone or

silicon (an indirect measure of silicone) in blood, tissue and

urine, but the meaning of these test results is unknown. Even if

simple techniques to detect silicone were available, they might

not be useful in detecting a breast implant rupture because small

amounts of silicone ordinarily " bleed, " even from intact

implants. Further, since silicone is found in food and many

other products, including commonly used medicines and cosmetics,

it would be hard to determine whether the silicone came from the

implant or another source.

The current informed consent document given to women who

enter the silicone breast implant clinical trial stresses that

only limited research has been conducted in this area and further

study is needed (see talk paper T92-35). Women with implants

considering breastfeeding are urged to check with their doctors

or FDA's Breast Implant Information Line at (800) 532-4440 for

the most current information.

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[Guest guest]

Thank you so much Sherry !!! . . . Where did you find

this article? . . . I've copied it to the SiliconKids

group.

Hugs,

Rogene