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FDA demands more information about breast implants
MEDICINE AND HEALTH POLICY
WHO praises Bam response but warns of disease HO and international relief experts have described Iran’s response to the Bam earthquake as “exemplary”, and a valuable experience that other countries can draw upon. David Heymann, a WHO special envoy who travelled to the devastated city as part of a UN disaster-assessment team, said the “swift and effective” Iranian response exemplified the health ministry’s previous experience of earthquakes. Jesper Lund, head of the UN disaster team, said the
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well-coordinated emergency teams “prevented it being a larger disaster than it already was”. The earthquake killed over 31 000 people, injured over 22 000, and left 75 000 people homeless. However, WHO warned that potential outbreaks of cholera, typhoid fever, malaria, and leishmaniasis are also a major concern. On Jan 8, the UN launched a flash emergency relief appeal to cover Iran’s basic needs over the next 3 months; including a request for over
US$4 million for health and nutrition (Lancet 2004; 363: 131). Money for reconstruction of destroyed hospitals and health centres is also included in the appeal, and is expected to amount to around $30 million. Heymann said several strategic decisions taken by the Iranian health authorities facilitated the rapid response. First, patients that required hospitalisation were not treated in Bam, but were instead evacuated to neighbouring provinces. A
combined rescue by the army, the ministry of interior, the ministry of health, and the Red Crescent Society of Iran airlifted more than 12 000 injured in the first 24–48 h. Second, that the Iranian government agreed to invite humanitarian assistance from over 40 different countries and organisations, Heymann said, enabled them to assume immediately primary healthcare responsibilities, including setting up 10 field hospitals. Another notable action was the division of the city of Bam, and neighbouring villages, into 12 medical zones, each of which partnered with a provincial hospital that sent medical teams from their own jurisdictions. A final example was the active zonal surveillance and disease management by health workers. These people visited families tent by tent, did assessments of what was needed, collected data, and provided medication for people who had lost their drugs for illnesses such as hypertension and diabetes. AP
Rights were not granted to include this image in electronic media. Please refer to the printed journal.
A physician examines a child in a temporary field hospital set up to care for the injured in Bam
John Zarocostas
FDA demands more information about breast implants he US Food and Drug Administration (FDA) said on Jan 7 that it would not approve a silicone breast implant made by Inamed Corp. The move was surprising, given that the agency’s outside advisers voted for approval last October (Lancet 2003; 362: 9393). The FDA would not say what it sought from Inamed, but 1 day later, it issued new guidance calling on silicone implant manufacturers to provide more information on how and how often implants rupture, how to diagnose socalled “silent” ruptures, and the consequences of silicone leakage. “What we want is a picture of the performance of the device over its lifetime”, said Dan Schultz, director of FDA’s office of device evaluation, in a press briefing.
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And, said FDA officials, physicians and patients should be given more information on whether—and how—to treat ruptures. The new guidance raises the bar on what was recommended last year, but it is still not a requirement for approval. David Feigal, director of the FDA radiological devices centre, would not say if the decision to issue the guidance was made before or after the contentious 2-day meeting on Inamed’s implant. During that gathering, critics lashed out at Inamed for providing only shortterm data. Panelists also discussed at length whether women with implants should undergo regular MRI to detect “silent” ruptures. The FDA recommends 10-year
monitoring of devices. But, manufacturers can seek approval with early data and complete follow-up after marketing. Feigal said this situation won’t change, but that manufacturers will be given options on how to give more data on ruptures. “We are open to different kinds of studies”, he said. Silicone implants were banned from the US market in 1992, but are available through clinical studies, which currently involve 40 000–50 000 women. “A lot of information has been accrued during the past 10 years, which increases our assurance of the safety of these products”, said Schultz. But, he added, more information is needed before any device can be approved. Alicia Ault
THE LANCET • Vol 363 • January 17, 2004 • www.thelancet.com
For personal use. Only reproduce with permission from The Lancet.
WHO praises Bam response but warns of disease HO and international relief experts have described Iran’s response to the Bam earthquake as “exemplary”, and a valuable experience that other countries can draw upon. David Heymann, a WHO special envoy who travelled to the devastated city as part of a UN disaster-assessment team, said the “swift and effective” Iranian response exemplified the health ministry’s previous experience of earthquakes. Jesper Lund, head of the UN disaster team, said the
W
well-coordinated emergency teams “prevented it being a larger disaster than it already was”. The earthquake killed over 31 000 people, injured over 22 000, and left 75 000 people homeless. However, WHO warned that potential outbreaks of cholera, typhoid fever, malaria, and leishmaniasis are also a major concern. On Jan 8, the UN launched a flash emergency relief appeal to cover Iran’s basic needs over the next 3 months; including a request for over
US$4 million for health and nutrition (Lancet 2004; 363: 131). Money for reconstruction of destroyed hospitals and health centres is also included in the appeal, and is expected to amount to around $30 million. Heymann said several strategic decisions taken by the Iranian health authorities facilitated the rapid response. First, patients that required hospitalisation were not treated in Bam, but were instead evacuated to neighbouring provinces. A
combined rescue by the army, the ministry of interior, the ministry of health, and the Red Crescent Society of Iran airlifted more than 12 000 injured in the first 24–48 h. Second, that the Iranian government agreed to invite humanitarian assistance from over 40 different countries and organisations, Heymann said, enabled them to assume immediately primary healthcare responsibilities, including setting up 10 field hospitals. Another notable action was the division of the city of Bam, and neighbouring villages, into 12 medical zones, each of which partnered with a provincial hospital that sent medical teams from their own jurisdictions. A final example was the active zonal surveillance and disease management by health workers. These people visited families tent by tent, did assessments of what was needed, collected data, and provided medication for people who had lost their drugs for illnesses such as hypertension and diabetes. AP
Rights were not granted to include this image in electronic media. Please refer to the printed journal.
A physician examines a child in a temporary field hospital set up to care for the injured in Bam
John Zarocostas
FDA demands more information about breast implants he US Food and Drug Administration (FDA) said on Jan 7 that it would not approve a silicone breast implant made by Inamed Corp. The move was surprising, given that the agency’s outside advisers voted for approval last October (Lancet 2003; 362: 9393). The FDA would not say what it sought from Inamed, but 1 day later, it issued new guidance calling on silicone implant manufacturers to provide more information on how and how often implants rupture, how to diagnose socalled “silent” ruptures, and the consequences of silicone leakage. “What we want is a picture of the performance of the device over its lifetime”, said Dan Schultz, director of FDA’s office of device evaluation, in a press briefing.
T
218
And, said FDA officials, physicians and patients should be given more information on whether—and how—to treat ruptures. The new guidance raises the bar on what was recommended last year, but it is still not a requirement for approval. David Feigal, director of the FDA radiological devices centre, would not say if the decision to issue the guidance was made before or after the contentious 2-day meeting on Inamed’s implant. During that gathering, critics lashed out at Inamed for providing only shortterm data. Panelists also discussed at length whether women with implants should undergo regular MRI to detect “silent” ruptures. The FDA recommends 10-year
monitoring of devices. But, manufacturers can seek approval with early data and complete follow-up after marketing. Feigal said this situation won’t change, but that manufacturers will be given options on how to give more data on ruptures. “We are open to different kinds of studies”, he said. Silicone implants were banned from the US market in 1992, but are available through clinical studies, which currently involve 40 000–50 000 women. “A lot of information has been accrued during the past 10 years, which increases our assurance of the safety of these products”, said Schultz. But, he added, more information is needed before any device can be approved. Alicia Ault
THE LANCET • Vol 363 • January 17, 2004 • www.thelancet.com
For personal use. Only reproduce with permission from The Lancet.