CLIENT

CHALLENGE

Due to a multi-million dollar PR effort funded by breast implant companies in litigation, most journalists and many medical professionals were convinced the devices were, if not proven safe, at least not likely to be dangerous.  Plastic surgeons and breast implant manufacturers stood to increase profits substantially if the devices were re-approved. They constituted a formidable political and media lobby.

Finally, the FDA process itself was complex and veiled in secrecy.

There was little access for advocacy organizations to monitor the situation.

RESPONSE

Turner Strategies had to nullify the science arguments in the media and to reengage a press corps exhausted by this story.  We also had to find non-profit partners willing to expend an enormous amount of energy on the campaign. We devised a strategy with multiple partners who had influence over competing segments of the media. Our efforts contributed to these results:

In May 2003, the National Organization for Women convened a behind-closed-doors meeting of scientists and clinicians to evaluate the research released since the Institutes of Medicine report in 1999.  The scientists then crafted a consensus document that was released at a July press event with a host of other advocacy organizations, including Public Citizen, the National Women's Health Network and the National Center for Policy Research for Women and Families. This event was combined with an afternoon Capitol Hill briefing featuring federal researchers whose work showed troubling problems with the devices. The release of this document generated intense national media coverage and caught the plastic surgeons and manufacturers completely off guard.

In August, a group of actresses harmed by silicone breast implants announced the formation of the support group In the Know, and at an entertainment community event in Los Angeles they called on the FDA not to re-approve silicone breast implants. They were joined by plastic surgeons who had once favored silicone gel breast implants but now refused to use them. This event generated coverage in all Los Angeles media and on national entertainment programs.  This move further surprised the plastic surgeons and manufacturers.

Also in August, the FDA announced its plans to convene a panel meeting on the topic in mid-October. NOW, Public Citizen, other advocacy groups and legislators decried the move.

In mid-September, the media began running stories about the first woman to tell her breast implant story fifteen years earlier. The pathos of her illness and lengthy quixotic crusade to keep the devices from harming another generation of women was featured in Parade, People, Time, USA Today, NBC, ABC, CBS and CNN.

In late September, the press began to run stories about the U.S. Department of Health and Human Services' lawsuit to recoup over one hundred million dollars in disability payments to women harmed by breast implants.

In early October, women from all over the country, including some of the actresses, gathered to demonstrate in front of the HHS chanting "No Way FDA, Corporate Greed is Not Okay" and the like. They repeatedly called HHS Secretary Tommy G. Thompson on their cell phones from the front courtyard of HHS. Thousands of posters were pasted all over town about the rally, particularly near the homes of key legislators and administration officials, the media and relevant offices.  Again, saturation media coverage added to the impression that there was no place for the FDA to hide on this issue.

The manufacturers' clinical trial data was released the week before the hearings. The data showed a shocking lack of follow up -- very few women were being properly evaluated for a product that might ultimately be put into the bodies of millions.  Even worse, the data showed appalling results, effectively undoing the previous decade of industry "spin."  Nearly half of the subjects required replacement implants within two years. One-fifth of the women were showing severe symptoms of various systemic illnesses within two years. The press covered the story exhaustively.

The October hearings resulted in five days of saturation media coverage.  Because of the media attention focused on the issue, news organizations staffed the entire hearing. For the first time, reporters were forced to sit and listen to all the horrible stories of suffering. Even more importantly, for the very first time, they heard FDA researchers and scientists discuss the problems with the devices. Journalists became champions for the women.

The firestorm created by our work took on a life of its own and continued (with a little help from Turner Strategies).

Nonetheless, the panel was deeply divided in its decision. A close 5-4 vote recommended approving the devices (one panel member had to leave early and four of the "yes" votes were plastic surgeons with a vested financial interest in their approval).

Editorial boards across the country vilified the decision. Shortly thereafter, panel members began contacting members of the advocacy community asking for help on reversing the recommendation.

The press continued to follow the story. Conflicts of interest were reported upon -- the lead advocate for implants on the panel was revealed to have taken a $25,000 grant from the manufacturer seeking approval. The other four plastic surgeons were shown to have received hundreds of thousand of dollars in income per year from putting the devices in.

Finally, the panel chair released a letter he had written to FDA Commissioner Dr. Mark McClellan in which he urged the FDA NOT to approved the devices. Another wave of media coverage followed this announcement.

RESULTS

The FDA declined to approve the devices in early January. According to one trade analyst, "because of the media scrutiny, they had no place to hide." The FDA itself said, "We couldn't approve these devices based on the available science."