As might be expected, this week’s FDA panel vote to recommend approval of the silicone gel breast implants made by Mentor (Santa Barbara, California) drew sharply conflicting reactions.
The American Society of Plastic Surgeons (ASPS; Arlington Heights, Illinois) and the American Society of Aesthetic Plastic Surgery (ASAPS; New York) – which say they are the two largest groups representing plastic surgery professionals – said they approved of the vote and that they hope the agency ultimately will approve marketing of both Mentor’s products and those made by Inamed (also Santa Barbara).
The two groups said in a joint statement that they are “prepared to work with the FDA and Mentor to fulfill the [panel-prescribed] conditions which include physician education, patent education, a registry and a commitment from the manufacturers for continued data collection.” They claim “a leadership role” in such activities and said they will assist the manufacturers in their efforts.
Mark Jewell, MD, president-elect of the ASAPS, said that the organizations also hopes for approval of Inamed’s implant products if the company “can satisfy the FDA’s remaining concerns.”
The ASPS and ASAPS have recently launched a joint web site – www.breastimplantsafety.org – in what they called “their ongoing education campaign concerning these products.” A statement on the site’s “Safety and risk” page says that studies support the use of silicone gel-filled implants “as a choice” for women. But it adds that “like all medical devices, breast implants may not last a lifetime” and frequent mammograms and other check-ups are necessary for this group of women.
Squarely on the opposite side of this issue is The Command Trust Network (Los Angeles), which said that the silicone gel products of both companies should be “kept off the market.”
It noted that the FDA’s own researchers “found that both companies failed to sufficiently respond to questions regarding the safety of their devices, but the panel still voted to ignore the scientific evidence.”
On its web site, the organization is urging women to contact Lester Crawford, acting FDA commissioner, to reject the applications, based on a lack of long-term data. “We must tell Acting Commissioner Dr. Lester Crawford to support the findings of FDA’s own scientists.” It added: “For the public, the FDA stamp of approval implies that there is no danger. Without long-term research on these implants it is impossible to draw such a conclusion.”
And it argued that rejection of the companies’ applications is necessary to “restore credibility to the FDA and [to] protect women from health risks posed by silicone implants.”
Besides noting the oft-repeated claim of health risks to women, Command Trust cites studies indicating that implants impede breast feeding and thus that implants “have become a public and pediatric health problem as they essentially deprive newborns of these benefits [of breast feeding].”
The National Research Center for Women & Families (Washington), equally critical of returning the implants to the market, cited FDA data extrapolation and other studies which predict high numbers of implant ruptures and subsequent medical problems.
Expressing “outrage” over one part of the panel’s decision – but for different reasons – was the American Academy of Cosmetic Surgery (Chicago). Though the organization said it approved the panel’s vote favoring Mentor’s application, it said the panel was limiting “patient choice” and was putting women’s health at risk by allowing the implant procedure to be done only by “board-certified plastic surgeons.”
“People deserve quality care, and there is no proof that a board-certified plastic surgeon is better qualified to perform a breast augmentation with these implants than a board-certified cosmetic surgeon,” according to Claude Crockett, MD, president of the academy.
The organization said it will “aggressively challenge” the guideline and that it is “investigating why a federal agency charged with protecting public health would use its authority to improperly restrict patient choice by precluding thousands of qualified cosmetic surgeons from utilizing silicone implants.”
The panel’s split decision – shadowed by the attendant and ongoing controversy – doesn’t provide a solid foundation for decision-making in the U.S.’s northern neighbor.
Health Canada reportedly has received six licensing applications from Inamed and Mentor and it last month held a “closed-door” meeting of scientists to consider those applications.
Earlier this week, Ujjal Dosnjh, Canada’s health minister, said that this panel of scientists is preparing a report to be issued this month. He said that the Canadian public also would be given a chance to express its views to an advisory panel considering the applications.
Silicone and saline implants entered the Canadian market in 1962, with manufacturers then withdrawing them in 1992 for safety concerns.
Currently, Health Canada grants to physicians their use of the implants on a case-by-case basis.