The recent FDA approval of a new breast implant is a reason for all women to rejoice. After years of stagnancy at the FDA in which the newest implants enjoyed by women outside from the U.S. were kept from American women, those needing reconstruction after mastectomy or wanting an augmentation will have more choices. Acting on data rather than pandering to uninformed activists represents an important step towards making the safest and most effective medical devices more widely available to those who need them.
Since the beneficiaries of this approval are the patients, it is perplexing as to why this advance was predominantly covered as a business story. Articles focused on industry economics and stock prices, but absent were stories about women whose lives were improved by these new devices during the rigorous clinical trials that justified their approval, and the many thousands of women who have been awaiting a better implant.
I was interviewed by the Los Angeles Times in 2006 when the FDA approved silicone implants. I explained why they were better for many patients, and I arranged for the reporter to interview several patients. Yet the editors placed this story in the business section, devoid of any content relevant to patients. With one in eight women destined to develop breast cancer and many women choosing to have a breast augmentation, this is a story of enormous interest that should have been presented in a health or lifestyle section.
The explanation of this enigma goes back to the widespread frivolous breast implant litigation of the early 1990s. Plaintiff attorneys sought to replace the largess of asbestos litigation, and the deep pockets of device manufacturers filled their ravenous appetites and the headlines of newspapers. The FDA's authority to regulate industry but not the practice of medicine further created focus on industry.
This has made the needs of patients secondary. Even a women's rights organization which has opposed all breast implant approval -- regardless of specific data -- begins its discussion of breast implants on its website by describing the breast implant industry as "cultivating women's insecurities." Is providing an implant to reconstruct an amputated breast cultivating insecurity? Is it consistent for a women's rights group to obstruct a woman's right to reconstruct or even augment her own breasts?
Suggesting that surgeons and patients are manipulated by industry is insulting and false. As a surgeon, these manufacturers are my suppliers. Together with my patients, we decide whether they will have a breast implant. Manufacturers spend little on marketing because they acknowledge they cannot affect demand.
The Sientra breast implant approval is a vindication of the scientific method. After two decades of acting in fear of a political backlash, the FDA has fulfilled its mandate to approve a device that has objectively demonstrated its safety and efficacy.
But it is too soon to celebrate. Similar implants made by Allergan and Mentor are yet to be approved, despite data that exceeds that of other available implants. How can that be rationalized by the agency?
Let us hope that reason will triumph.
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