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.
Follow Steven Teitelbaum on Twitter: www.twitter.com/drteitelbaum
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We can only hope that the bureaucratic morass that stifles innovation and implementation of many beneficial drugs and devices from reaching the patient will weaken and allow for improvement in many aspects of our lives.
It is precisely this type of debasing journalism and perception that medical treatments and devices are simply fodder for Wall Street investors that complicates our genuine desire to provide the best care for our patients. We are long overdue to return to considering the care of patients to be a sacrosanct art worthy of protection and support.
We couldn't agree more that the biggest beneficiary here is the patient. In fact, when we first wrote about the FDA approval we looked at what it meant for future breast aug patients: http://www.realself.com/blog/gummy-bear-breast-implants-fda-approved
Really!! The uninformed activists he derides include women's health authorities who have published the definitive volume of information regarding women's health, women who hold PhDs in public health and those who have studied and educated themselves to the lack of scientific integrity in the studies submitted to the FDA. Many of FDA's own scientists have not supported the safety studies submitted by manufacturers. It was only when FDA changed its standard of approval from "safe" to "reasonably safe" that implants were approved.
Dr. Teitelbaum fails to mention that 80% of women who get breast implants are for changing their breast size and 20% are for reconstruction after breast cancer. And he fails to mention the amount of money doctors like himself make from "annuity medicine" which means they make money putting them in and then taking them out and then putting them in and taking them out again. Many women fall on a slippery slope to poverty because breast implant surgery is paid with cash up front regardless of the pain and discomfort caused by the implants that have been sold to them by the implanting physician.
Dr. Teitelbaum, you need to seriously re-think this issue! Get the facts from the people you so strongly oppose.