No Evidence Linking Silicone Breast Implants to Disease
.K. Independent Review Group Concludes
WASHINGTON, July 14 /PRNewswire/
In a report released today, the Independent Review Group, at the request of the United Kingdom’s Minister for Health, has examined evidence related to the possible health risks associated with silicone gel breast implants and found that:
There is no epidemiological evidence for any link between silicone gel breast implants and any established connective tissue disease;
Good evidence for the existence of atypical connective tissue disease or undefined conditions, such as “silicone poisoning” is lacking; and
There is no evidence that children of women with breast implants are at increased risk of connective tissue disease; among other findings.
In addition to its findings that there is no evidence linking silicone gel breast implants and autoimmune connective tissue disease or undefined “atypical” illness, the Independent Review Group made specific recommendations including:
All patients undergoing cosmetic breast augmentation surgery should be able to obtain, free of charge, from a designated body, comprehensive information about the benefits and risks of such surgery;
A “cooling off” period of several days between a patient’s initial consultation with the surgeon and the operation; and
A consent form including a checklist of issues should be developed and discussed in detail with patients considering breast augmentation surgery. The form must be signed by both the surgeon and the patient; among other recommendations.
This report was issued on the heels of the July 4th EQUAM — European Committee on Quality Assurance and Medical Devices in Plastic Surgery — consensus declaration that, “There are conclusive scientific — clinical, immunological, epidemiological — data, that silicone gel-filled breast implants do not cause any autoimmune nor connective tissue diseases. There is no scientific evidence that such things as silicone allergy, silicone intoxication, atypical disease, or a ‘new silicone disease’ exist. There is a normal foreign body reaction to every implant, but this is not immune disease. Silicone implants do not adversely affect pregnancy nor breast-feeding nor the health of breast-fed children.”
More than 20 medical studies conducted by such institutions as The Mayo Clinic and Harvard Medical School have consistently found no statistically significant evidence connecting silicone breast implants to any disease. This product has been the subject of one of the largest mass torts in American litigation history and has resulted in the bankruptcy of one manufacturer. Banned from the U.S. market in 1992 by then FDA Commissioner David Kessler except in cases of reconstructive surgery, silicone breast implants remain the implant of choice for women seeking breast reconstructive surgery after mastectomy or women considering cosmetic breast augmentation or reduction surgery. According to a recent CNN report, “Women are getting breast implants in record numbers.”