New surgical devices and ethical challenges

Responsibilities of the media, FDA, and professional societies

By Mary H. McGrath, MD, MPH

My experience with the FDA during the regulatory controversies over breast implants, mentioned above by Dr. Schultz, was the crucible in which my views about devices and the ethics of surgical innovation were forged. My comments here will focus on observations from that experience and then on the function of journalism in these issues, the role of the FDA, and the positive part that professional societies can play as we grapple with emerging technologies.

BREAST IMPLANTS: A CASE STUDY IN REGULATORY COMPLEXITY

A long and winding path to approval

Although breast implants had been on the market in the United States since the early 1960s, they did not fully come onto the FDA’s radar screen until 1991. The FDA had not been authorized by Congress to regulate medical devices until 1976, and at that point, other devices had higher priority. By the time of the first FDA panel hearings on breast implants, in November 1991, an estimated 1 million women in the United States had breast implants.

The 1991 hearings were driven largely by anecdotal reports in the literature suggesting a possible association between breast implants and rheumatoid and autoimmune disorders. As a plastic surgeon who specialized in breast reconstruction, I was a member of the panel for the hearings. The wave of public concern and the paucity of evidence in support of safety led then-FDA commissioner David Kessler to call for a moratorium on the use of breast implants in January 1992. Three months later, the FDA ruled that implants would be limited to use only in clinical trials.

These actions produced a panicked response from the public, with silicone gel-filled breast implants being removed from more than 100,000 US women in the ensuing 2 to 3 years. People do not often consider the risk created by patients going back for surgery based on the fear resulting from a ban.

A huge class action lawsuit was brought against implant manufacturers, which culminated in Dow Corning—the largest manufacturer of implants at the time—abandoning the implant business and settling the suit for millions of dollars. Only two of five manufacturers continued to make breast implants, both of which manufacture them outside the United States.

Meanwhile, subsequent studies required by the FDA were gradually completed, leading the agency to approve saline-filled implants for marketing in 2000. In 2006, the agency approved silicone gel-filled implants after reviewing 553 studies that collectively demonstrated no association between these implants and systemic disorders. Both types of implants are marketed today, yet FDA approval carried some special conditions. Core study patients were to continue to be followed with magnetic resonance imaging screening through at least 9 years. Implant manufacturers were required to submit annual reports to the FDA, and a device retrieval program was set up. An implant registry also was established for postmarket surveillance. The registry was developed in collaboration with the FDA and professional societies, which also have developed content for formal patient education and professional training programs mandated as conditions of marketing approval.

Interest groups and the media: Fully in the mix

A multitude of interest groups were present and vocal throughout this entire episode, from the hearings in 1991-92 through the hearings leading up to the most recent approvals in recent years. In addition to obvious stakeholders, such as manufacturers, surgeons, and patients, the media packed the large hearing rooms and interviewed a wide range of interested parties, including investment fund managers, patients, and implant opponents. Groups such as “Fathers Against Breast Implants” typified the frustration that people felt about the sexualization of the culture. Every day, the panel hearings became front-page news.

FDA approval had an immediate market effect, and implant sales surged. At the same time, the media raised questions about whether the FDA’s regulatory approach of requiring reasonable assurance of safety was sufficient and whether a higher level of evidence for safety and efficacy should be required for this type of device. News stories also examined societal ethics about quality of life and how much medical risk people should be allowed to accept for the sake of cosmetic procedures.^3–5

THE ROLE OF THE PUBLIC—AND JOURNALISM

The case of breast implants illustrates the important role that the media can play in how emerging medical technologies are greeted, but this role should be viewed in the broader context of the key relationships involved in the development and use of surgical devices. Central to device development and use, of course, is collaboration between the medical profession and industry, as discussed at length earlier in this conference. I would like to focus now on two other major players that influence device development and use—the public and regulatory bodies (ie, the FDA).

Medical journalism falls short on two core principles

A key determinant of public views of new devices and other medical technologies is the discussion of those technologies in the media. Medical science has become increasingly publicized in both print and electronic media in recent years in response to high levels of public interest in medical news. In 1998, the New England Journal of Medicine published a lecture by medical journalist Dr. Timothy Johnson on the relationship between medicine, the media, and the public with regard to emerging devices and other products.⁶ Johnson argued that in the rush to satisfy the public hunger for medical news—and also to promote themselves—journalists and medical scientists have failed to adhere to some core principles: that science examines collective data over anecdotal data, and that getting a story right is better than getting it first. Moreover, weakened adherence to these principles has been exacerbated by the proliferation of business-related medical communications (press releases, press conferences, advertising infomercials, and the like) from biomedical product manufacturers, medical centers, and even individual practitioners as they try to increase their market share in today’s competitive environment. 

Johnson pointed out that whereas journalists used to present opposing viewpoints based on multiple sources, they now too often strive to be the first to report a medical story and to make it as forceful and dramatic as they can. Medical stories get more attention from the public, he noted, if they are unambiguous and use an anecdotal account to add “human interest.”6 These developments have been aided by the explosion in the number and type of news sources and the eclipse of journalists by public relations firms and—I would add from our 2008 perspective—bloggers.

Despite the challenge, potential solutions are at hand

Johnson argued that such excesses in the media are not in the public interest. Just as general news is based on facts, sources, and opinions, medical news should be based on data, probabilities, and conclusions. He proposed that medical reporters be required to undergo credentialing to demonstrate a background in biostatistics and epidemiology. Although this idea may seem radical, it has a precedent: meteorologists must be scientifically trained before reporting the weather forecast, a topic that is certainly no more important than medicine.

My view is that medical professionals have a responsibility to educate the public about emerging technology. Although we still do not require credentialing of medical reporters, we see more physicians contributing to the better broadcast and print media outlets. Some medical schools now offer training in medical journalism. In addition, the FDA has robustly implemented a directive to make public education a priority on its Web site.

Another hopeful sign is that some medical professional societies have begun to respond to issues like these through their codes of ethics. For instance, the society for my specialty—the American Society of Plastic Surgeons—has long had injunctions against false and deceptive advertising but now also bans exaggeration of one’s skills or claims to have been the first to use a new procedure or device, whether in an advertisement or, notably, in a media interview. Members who commit such transgressions can be brought before our ethics committee and asked to account for them.

THE ROLE OF THE FDA—AND AN OPPORTUNITY FOR PROFESSIONAL SOCIETIES

Let me turn to the other major player in device development beyond manufacturers and the medical profession—the FDA.

The FDA’s relationship is with the manufacturer; it has never been empowered to regulate the practice of medicine or the conduct of surgery. The FDA cannot dictate how a device is used (except via the manufacturer’s product labeling) or which physician specialties may use it. Physicians may use a device off label, but a manufacturer that deliberately markets a device for an off-label use (outside of the conditions outlined by Rebecca Dresser in the previous session in this conference) is subject to regulatory penalties.

Increasing need for training requirements in device approvals

In the last few years, however, barriers preventing the FDA from regulating surgical practice have begun to break down as it has become increasingly obvious that a surgeon’s use of a device affects the performance of that device. For this reason, training in the use of a device must be integral not only to early development and clinical investigation but also to eventual use.

Until about 8 years ago, neither device manufacturers nor the FDA required end-user training. When such a requirement was first discussed, it was seen as an invalid effort to regulate medical practice. But a couple of gaps in this thinking eventually became obvious:

• Premarket clinical trials of a device are conducted at only a few institutions and by surgeons who tend to be very familiar with the product. This raises real questions about how transferable the resulting data are to broader clinical practice.
• Mishandling of modern devices, which are increasingly complex and delicate, can easily result in product failure, a problem that can be very costly and damaging to the manufacturer.

Recognition of such problems has prompted the requirement for physician training in the labeling of an increasing number of devices. For instance, tracking done by the American College of Surgeons showed that 2 years ago, 8 of 13 FDA-approved devices for use in general surgery were approved with training requirements. The details of these prescribed training processes have not been very specific, however, and even the general requirement for training raises a host of resulting questions:

• Who should do the training—the device manufacturer, hospitals, or professional societies?
• What should training consist of—a course? Should there be a certificate upon completion?
• Who can take the training? Should it be confined to specific surgical specialties?
• Who designs the curriculum? Who evaluates the quality of the training? Who determines if the trainees are adequately prepared at the end?

Lessons from the American College of Surgeons

I would like to address some of these issues by drawing from the recent experience of the American College of Surgeons, which formed its Committee on Emerging Surgical Technology and Education (CESTE) about 8 years ago. The charge of CESTE was to formulate a comprehensive approach to questions like these and develop guidelines and mechanisms for a threefold mission: assessing new technologies, educating surgeons on new procedures and technology in their postresidency years, and verifying that this training results in actual acquisition of new skills.

Technology assessment. Technology assessment has proved to be the Achilles’ heel of the CESTE efforts, because it is a difficult and costly long-term proposition. This is particularly true of device assessment, as devices are frequently modified to introduce incremental improvements over time.

The American College of Surgeons has sponsored only one randomized clinical trial—a collaboration 12 years ago with the Veterans Administration to evaluate open versus closed hernia repair. The study was very successful, eventually producing 42 published papers. However, by the time the follow-up was finished, the research question was moot, as everybody knew that closed hernia repair was a fine and acceptable approach. Firsthand experience with the complexity, the expense, and the 10 years needed to complete this surgical technology trial convinced CESTE that undertaking primary assessment was beyond its scope. It has instead focused on becoming a clearinghouse for identifying new devices and procedures that are on the horizon and preparing surgeons for their arrival via its education mission.

Education. Education has been CESTE’s greatest success. The committee has articulated goals for its courses with content and syllabi and has developed formats, instructors, and testing. Partnering with industry, CESTE has set up a number of skill centers around the country that involve cost-sharing, identifying learning needs, approving curricula and content, and assessing and verifying trainees.

Verification. Verification of education and training is necessary—documentation may be important for surgeons when requesting privileges—but is not always easy to do. Some components of training are easily verifiable: one can document that a physician attended a course, or one can ensure that didactic information was learned by using a written test. But demonstrating that someone actually acquired new skills is more difficult, and CESTE is just beginning to apply this level of verification to some of its courses. Ideally, CESTE will one day have a proctoring measure at trainees’ home institutions to observe trainees actually applying their new skills in supervised clinical cases.

The first 8 years of the CESTE initiatives have been a learning process with more than a few challenges, but I believe the American College of Surgeons should be applauded for vigorously taking on the responsibility for training postgraduate surgeons in new and innovative technologies. I share its belief that professional organizations should serve this role, and this type of leadership from other medical and surgical societies will help address many of the challenges discussed earlier in this conference.