SILVER SPRING, MARYLAND—Dawn Criss took a deep breath and stepped to the microphone positioned before dozens of international medical professionals at the headquarters of the U.S. Food and Drug Administration. “Please take textured breast implants off the market,” the rural Alberta woman said in a firm voice during a Monday hearing on breast implant safety.“Cancer is a hard reality for many of us to deal with. It affects not only our bodies, but our minds, relationships, our working ability and our own sense of security. It takes away hope.”Criss, who acquired a rare form of cancer associated with her implants, was one of four Canadian women — along with a Canadian researcher — who appeared before the FDA panel urging a ban on textured breast implants they say are sickening women. The health impacts range from autoimmune-like symptoms including cognitive issues, fatigue and muscle pain to a rare form of lymphoma called breast implant associated anaplastic large cell lymphoma (BIA-ALCL). There are an estimated 700 cases of BIA-ALCL reported internationally, overwhelmingly tied to textured implants — devices coated with a sandpaper-like surface as opposed to smooth. The implants have been taken off the market in Europe and Brazil. Health Canada has documented 28 confirmed and another 28 suspected cases of BIA-ALCL in Canada, Amanda Jones, a senior scientific evaluator for Health Canada, told the FDA committee. Of the total 56 cases, 45 have been attributed to textured implants, Jones said. The remaining cases were designated as “not specified.” None of the 56 cases are tied to smooth implants. One brand of textured implants called Biocell, manufactured by industry giant Allergan, have 7.1 to 8.3 times greater risk of BIA-ALCL than other brands, Dr. Mark Clemens, a Houston plastic surgeon and leading researcher on breast implant issues, testified before the panel. “It is not just texturing vs. non-te ...
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