Amid a swirling and controversial debate pitting women's desire for autonomy and making their own healthcare choices vs. the potential risks of those choices, the FDA's General and Plastic Surgery Devices advisory panel last month voted to reverse a decade-long prohibition against the use of silicone breast implants strictly for cosmetic purposes. Following two days of debate and deliberation, the panel in a narrow 9-6 vote recommended that Inamed (Santa Barbara, California) receive FDA marketing approval for the implants, other than for reconstructive surgery. But it did so with a variety of stiff caveats a long list of conditions that some observers said the company would find difficult to meet if commercialization is to be profitable.
The conditions requested by the panel and which Inamed agreed to comply to included conducting 10-year follow-up studies, supplying annual reports of those studies to the FDA and establishing a patient registry by an independent organization to track the efficacy of the implants through the lifetime of implanted patients; developing patient education and "thorough" informed-consent documentation concerning the risks of the implants; and third-party development of training programs for implanting physicians as a way of evaluating their training to do the implants and follow-up monitoring. The conditions agreed to were key to wresting a positive vote from the panelists who appeared convinced of the product's efficacy but were concerned about safety issues and the lack of long-term data supporting the company's safety claims.
Before its vote, the panel heard a marathon of emotional testimony presented both from women who said they had suffered serious ill effects from breast implants and others who said they were aware of the risks but were passionate about the ability to choose. And the panelists themselves repeatedly expressed frustration over lack of long-term data of 10 years or more on the device, but their criticisms usually were not directed at Inamed.
Thomas Whalen, MD, panel chair, said he normally abstains from commenting during panel deliberations, but he criticized the FDA in how it has handled the breast implant issue overall. "A decade has passed, and we sat here today talking about two- and three-year data. I'm flabbergasted. The data wasn't asked for, so the data wasn't given." The panel determined that Inamed's data, even though short-term, shows that silicone implants are effective, particularly for breast cancer patients undergoing reconstruction surgery. Inamed's study compared its silicone implants with its own saline implants and found that they perform equal to, or better, than saline. The most contentious finding for panel members, however, was data showing that 46% of reconstruction patients undergo re-operation within three years.
Most panelists agreed that, although silicone implants aren't meant to last a lifetime and come with risks, they should be available to the women who want them. "Ethically, patient autonomy is paramount," said panelist Nancy Dubler, director of the division of bioethics at Montefiore Medical Center (New York) and professor of bioethics at the department of epidemiology and population health at Albert Einstein College of Medicine (Bronx, New York). She said that patients should "have the right to do what they want, even if it might be a foolish decision." Dubler also placed responsibility for rupture risk rather squarely on Inamed's shoulders. "I was on this panel 11 years ago when silicone implants were restricted, and it boggles my mind that in that time the company has made no attempt to make a better product so that it might have a lower rupture rate," she said.
According to several women's advocacy groups who are protesting the lifting of restrictions on the device, the panel's decision means that women are likely to be harmed by a product they say is not safe. "It's a black day for the women of this country when our government doesn't protect us from such dangerous products," said Lynda Roth, leader of the Coalition of Silicone Survivors (Greeley, Colorado).
After the meeting, Nick Teti, chairman, president and chief executive officer of Inamed, told The BBI Newsletter that "both the FDA and us wanted a fail-safe mechanism, and we will work to ensure it's done."
GE to pay $9.5 billion for Amersham
General Electric (Fairfield, Connecticut) in mid-October agreed to purchase Amersham (Little Chalfont, UK), the UK's largest life sciences company, in an all-stock transaction valued at $9.5 billion. The acquisition will create a $13 billion business, with the two companies saying the consolidation will have the broad vision of driving the development of "personalized" medicine. The proposed purchase closely followed GE's closing of its acquisition of Instrumentarium (Helsinki, Finland) in a deal valued at $2 billion (see Report from Europe, page 321). The two acquisitions assure General Electric's GE Medical Systems (Waukesha, Wisconsin) unit of dominant and expanding positions in several medical technology sectors both in Europe and around the globe.
Speaking at a press conference in London to unveil the Amersham purchase, Jeffrey Immelt, GE chairman and chief executive officer, said the acquisition "opens up a new chapter in healthcare." He said the combination of the two firms will accelerate development of molecular imaging and personalized medicine, and he envisioned the prediction and treatment of disease with tailored therapies, "in a way no one else could accomplish." Immelt, who was CEO of GE Medical before advancing to the top jobs with the parent company, added: "GE and Amersham will be an exciting combination of talents, businesses and technologies." He said Amersham's diagnostic pharmaceutical and life sciences business would add "new, high-growth platforms to GE Medical's diagnostic imaging, services and healthcare information technology businesses." And he projected that the combination of technical and market knowledge "will allow GE to accelerate the development of molecular imaging and personalized medicine where it will be possible to predict and treat disease with therapies tailored to the individual."
Amersham will be combined with GE Medical, under a new banner, GE Healthcare Technologies, which will be headquartered in the UK. Amersham's chief executive officer, Sir William Castell, will become CEO of the merged entity and will join the board of General Electric as a vice chairman. The current head of GE Medical, Joseph Hogan, will remain in that post. Castell, who joined Amersham in 1989 and has since taken it through a series of mergers, said he had been talking to Immelt about the possible combination for more than two years. "This business combination gives us a leadership position in today's diagnostic market and allows us to take the vision of molecular medicine forward to personalized medicine, tailored therapeutics and diagnostics," Castell said. "We will be predicting disease because of genetic predisposition, finding disease early, profiling cancers to get the right therapeutics and tracking disease using imaging technology."
Overall, the companies said that the broadest vision will be made reality by marrying GE's X-ray, magnetic resonance imaging and positron emission tomography scanning machines with Amersham's imaging agents and radiopharmaceuticals.
Phillip Drew, who follows the diagnostic imaging sector for BBI and its sister publication, Diagnostics & Imaging Week, said that the acquisition "creates a new avenue of development for General Electric. It goes in a direction where they've not ever been very active in the past laboratory equipment and reagents. It's a natural fit in that Amersham is an important supplier of radiopharmaceuticals and GE makes the gamma cameras and PET [positron emission tomography] cameras that use those pharmaceuticals," Drew observed.