Calgary Herald

Silicone under scrutiny once again

- MARILYNN MARCHIONE

U.S. health regulators say they’ll convene a public meeting of medical advisers next year to discuss new science on breast implant safety, including an independen­t analysis that was published over the weekend suggesting certain rare health problems might be more common with silicone gel implants.

The Food and Drug Administra­tion said it would hold the meeting even as its officials and several independen­t experts disputed the new work.

The study involves nearly 100,000 women and is the largest long-term safety analysis of silicone implants since 2006, when they were allowed back on the U.S. market after a 14year gap due to safety concerns.

“We completely stand behind this study and we do feel it’s our best data to date,” said lead researcher Dr. Mark Clemens, a plastic surgeon at the University of Texas MD Anderson Cancer Center.

The journal Annals of Surgery published the report.

Each year in the U.S., about 400,000 women get an implant and most choose silicone over saline. Three-fourths are for women who want bigger breasts; the rest are for reconstruc­tion after cancer surgery.

“Breast implants are not lifetime devices” and up to 20 per cent of women getting them for enlargemen­t need to have them removed within eight to 10 years, the FDA’s website warns.

Complicati­ons can include infections, wrinkling, scarring, pain, swelling and implant rupture. Users also may have a very small but increased risk of a rare lymphoma, a type of cancer, the FDA has said.

But the agency decided there was not enough evidence to tie silicone implants to other problems such as immune system and connective tissue disorders, so it approved devices from two makers — Allergan and Mentor Corp. — in 2006.

FDA required them to do more studies on how women fared, and the researcher­s used these reports in an FDA database for their analysis.

Compared to women without implants, those with silicone implants seemed to have greater rates of an immune system disorder called Sjogren syndrome, a connective tissue disorder called scleroderm­a, and the skin cancer melanoma, although cases of these were rare, the researcher­s reported. But rates for other problems such as fibromyalg­ia were lower among implant users. Reproducti­ve problems such as birth defects and stillbirth­s were mixed and inconsiste­nt.

Furthermor­e, a higher rate of rheumatoid arthritis was tied to one brand but a lower rate for another. The difference gets to what critics called a fundamenta­l flaw in the data used for the analysis: One implant maker required proof of diagnosis by a doctor rather than just a patient reporting a problem to include it in the database; the other did not.

“This study is messy ” and has the potential to create more anxiety than insight, said Dr. Andrea Pusic, plastic surgery chief at Brigham and Women’s Hospital in Boston and president-elect of the Plastic Surgery Foundation, which supports research and advocacy by the American Society of Plastic Surgeons.

Dr. Charles Thorne, plastic surgery chairman at Lenox Hill Hospital in New York and president elect of the American Society of Aesthetic Plastic Surgery, said the inconsiste­ncy in some of the results “is a little hard to explain” since the devices are similar chemically.

But the study is a worthy effort, he said.

 ?? DONNA MCWILLIAM/THE ASSOCIATED PRESS ?? Silicone breast implants have again prompted concern.
DONNA MCWILLIAM/THE ASSOCIATED PRESS Silicone breast implants have again prompted concern.

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