Advertisement

FDA requests moratorium on use of silicone gel-filled breast implants

By
DOUGLAS A. LEVY

WASHINGTON -- The Food and Drug Administration urged doctors Monday to stop using silicone gel-filled breast implants until new information linking the devices to debilitating diseases can be evaluated.

FDA Commissioner David Kessler said new safety concerns were raised by information that reached him since an advisory panel recommended in mid-November continued availability of the implants.

Advertisement

The new information included reports of possible implant-related illness, additional scientific studies, and further details on implants made before 1985.

Kessler told a news conference that 'physicians should cease using them and manufacturers should stop shipping them' until the further information can be studied. 'Women considering implants deserve to know whether these products are safe enough to use.'

While the greatest concern is about silicone gel leaks from a ruptured implant, other risks associated with the devices include implant hardening and interference with breast cancer screening X-rays.

In November, an FDA advisory panel said implants were not proven safe but they should still be sold to women who choose to accept potential risks pending further studies.

But Kessler said Monday, 'The information we've acquired since the last panel meeting, rather than dispelling doubts, has increased our concerns about the safety of these products.

Advertisement

'For example, we've recently received reports from rheumatologists that they are seeing an increasing number of autoimmune diseases among breast-implant patients.'

Autoimmune disorders are diseases that cause the body's immune system to fight against other body components.

Kessler said the moratorium is the most appropriate action pending advisory committee consideration of the new information, which will take place within 45 days.

However, at least two medical groups were unhappy with the FDA decision.

'The (American Medical Association) believes this option should remain available to patients,' said Dr. Mitchell Karlan, a Los Angeles cancer surgeon and member of the American Medical Association's Council on Scientific Affairs.

'These devices have been implanted into patients for more than 30 years, and we are aware of no scientific evidence that such implants cause cancer, promote cancer or increase the risk of cancer.'

Although the FDA action does not affect implants filled with saline, or salt water, Karlan said those implants are not as good as the silicone gel-filled ones. '(A saline implant) doesn't have the softness, the femininity,' he said, that patients seek when having reconstructive surgery.

The president of the American Society of Plastic and Reconstructive Surgeons, Dr. Norman Cole, said his group will comply with Kessler's moratorium request but 'cannot cooperate enthusiastically.'

Advertisement

'There has been no evidence that there are any long-term health risks shown to be related to implants,' Cole said. 'If there is information that these implants are unsafe, we want to be the first to know about it.'

But Dr. Sidney Wolfe, a consumer advocate and head of Public Citizen Health Research Group, said Kessler's decision does not go far enough.

'It is irresponsible for the FDA to do anything other than recall all silicone gel-filled implants,' Wolfe said, claiming plastic surgeons will continue implanting them despite Kessler's moratorium request.

Kessler urged women considering implants to await further FDA action. Those who already have implants should be periodically checked for rupture or other complications, but Kessler said, 'If you are not experiencing any difficulties, there is no need to consider removing the implants.'

Silicone gel-filled implants are used in about 150,000 women each year, with 80 percent of the surgeries for breast enlargement. The remaining 20 percent are for reconstruction following cancer surgery.

The FDA advisory committee heard testimony from dozens of witnesses on both sides of the issue. Women claiming serious health damage from faulty implants urged the FDA to order the products off the market. Others, including breast cancer patients, said availability of the implants is in the best public health interest.

Advertisement

Plastic surgeons and cancer support groups said women unable to have implants might choose not to have breast cancer surgery.

Dow Corning Wright of Arlington, Tenn., one of four firms seeking FDA approval of its implants, was reprimanded last week by the FDA for allegedly misleading callers to its information line about the safety of breast implants.

Three other implant makers -- Bioplasty Inc. of Minneapolis, McGhan Medical Corp. of Santa Barbara, Calif., and Mentor Corp, also of Santa Barbara -- also seek FDA approval for continued marketing of implants.

An FDA advisory panel said in November that the implants are not proven safe but they should still be sold to women who choose to accept any potential risk.

But Kessler said Monday that since the advisory panel's last meeting, 'we have received new information about the implants that increases our concern about their safety.'

'Today I am requesting a moratorium on the further use of all silicon gel breast implants until our advisory committee panel ... can reconvene to consider new information on the safety of these devices,' Kessler said.

He said the panel will meet within 45 days.

'Until the panel meets and we have had an opportunity to review its recommendations, I am asking that physicians cease using silicon gel implants,' Kessler said, adding, 'As physicians our first obligation is to do no harm.'NEWLN: more

Advertisement

Kessler also asked manufacturers of the implants 'to stop distributing these products during this period.'

'Given our heightened concern about the safety of the gel implants, I believe the moratorium on further use is the most responsible action that I can take,' Kessler said.

'Our decision does not apply to saline-filled implants, which will continue to be available through the moratorium,' Kessler said.

Last November, the advisory panel's chairmman, Dr. Mary Connell, said, 'We feel these products do represent a public health need. We recommend they remain on the market,' but further scientific study to determine their long-term safety should be required.

The committee rejected safety claims made by four implant makers.

Silcone gel-filled breast implants have been used by about 2 million women for three decades. They were marketed before a law put such devices under FDA regulatory jurisdiction.

Risks associated with the implants include hardening of tissue surrounding the implant, rupturing and interference with mammography screening for breast cancer. Concerns also have been raised about health consequences of silicone leakage.

The FDA advisory committee heard testimony from dozens of witnesses on both sides of the issue. Women who claimed serious health damage from faulty implants urged the FDA to pull the products off the market, while others, including numerous women who were treated for breast cancer, said availability of the implants was in the best public health interest.

Advertisement

Plastic surgeons and cancer support groups said women who were unable to have implants for reconstruction after breast cancer surgery might choose not to have breast cancer treated.

Makers of the implants claimed consumer groups urging a ban based their claims on faulty data.

'A number of individuals and groups have engaged in junk science making sensational claims of adverse effects,' said Dr. Robert LeVier, technical director for Dow Corning Wright, the nation's leading maker of the implants.

Dow Corning Wright, based in Arlington, Tenn., is one of four firms seeking FDA approval of its implants. The firm was reprimanded last week by the FDA for allegedly misleading callers to its information line about the safety of breast implants.

Three other companies -- Bioplasty Inc. of Minneapolis, McGhan Medical Corp. of Santa Barbara, Calif., and Mentor Corp, also of Santa Barbara -- also seek FDA approval for continued marketing of their implants.

The Food and Drug Administration urged doctors Monday to stop using silicone gel-filled breast implants until new information linking the devices to debilitating diseases can be evaluated.

FDA Commissioner David Kessler said new safety concerns were raised by information that reached him since an advisory panel recommended in mid-November continued availability of the implants.

Advertisement

The new information included reports of possible implant-related illness, additional scientific studies, and further details on implants made before 1985.

Kessler told a news conference that 'physicians should cease using them and manufacturers should stop shipping them' until the further information can be studied.

'Women considering implants deserve to know whether these products are safe enough to use,' he said.

While the greatest concern is about silicone gel leaks from a ruptured implant, other risks associated with the devices include implant hardening and interference with X-rays screening for breast cancer.

In November, an FDA advisory panel said implants were not proven safe but they should still be sold to women who choose to accept potential risks pending further studies.

But Kessler said Monday, 'The information we've acquired since the last panel meeting, rather than dispelling doubts, has increased our concerns about the safety of these products.

'For example, we've recently received reports from rheumatologists that they are seeing an increasing number of autoimmune diseases among breast-implant patients.'

Autoimmune disorders are diseases that cause the body's immune system to fight against other body components.

Kessler said the moratorium is the most appropriate action pending advisory committee consideration of the new information, which will take place within 45 days.

Advertisement

However, at least two medical groups were unhappy with the FDA decision.

'The (American Medical Association) believes this option should remain available to patients,' said Dr. Mitchell Karlan, a Los Angeles cancer surgeon and member of the American Medical Association's Council on Scientific Affairs.

'These devices have been implanted into patients for more than 30 years, and we are aware of no scientific evidence that such implants cause cancer, promote cancer or increase the risk of cancer.'

Although the FDA action does not affect implants filled with saline, or salt water, Karlan said those implants are not as good as the silicone gel-filled ones. '(A saline implant) doesn't have the softness, the femininity,' he said, that patients seek when having reconstructive surgery.

The president of the American Society of Plastic and Reconstructive Surgeons, Dr. Norman Cole, said his group will comply with Kessler's moratorium request but 'cannot cooperate enthusiastically.'

'There has been no evidence that there are any long-term health risks shown to be related to implants,' Cole said. 'If there is information that these implants are unsafe, we want to be the first to know about it.'

But Dr. Sidney Wolfe, a consumer advocate and head of Public Citizen Health Research Group, said Kessler's decision does not go far enough.

Advertisement

'It isirresponsible for the FDA to do anything other than recall all silicone gel-filled implants,' Wolfe said, claiming plastic surgeons will continue implanting them despite Kessler's moratorium request.

Kessler urged women considering implants to await further FDA action. Those who already have implants should be periodically checked for rupture or other complications, but Kessler said, 'If you are not experiencing any difficulties, there is no need to consider removing the implants.'

Silicone gel-filled implants are used in about 150,000 women each year, with 80 percent of the surgeries for breast enlargement. The remaining 20 percent are for reconstruction following cancer surgery.

The FDA advisory committee heard testimony from dozens of witnesses on both sides of the issue. Women claiming serious health damage from faulty implants urged the FDA to order the products off the market. Others, including breast cancer patients, said availability of the implants is in the best public health interest.

Plastic surgeons and cancer support groups said women unable to have implants might choose not to have breast cancer surgery.

Dow Corning Wright of Arlington, Tenn., one of four firms seeking FDA approval of its implants, was reprimanded last week by the FDA for allegedly misleading callers to its information line about the safety of breast implants.

Advertisement

Three other implant makers -- Bioplasty Inc. of Minneapolis, McGhan Medical Corp. of Santa Barbara, Calif., and Mentor Corp, also of Santa Barbara -- also seek FDA approval for continued marketing of implants.

An FDA advisory panel said in November that the implants are not proven safe but they should still be sold to women who choose to accept any potential risk.

But Kessler said Monday that since the advisory panel's last meeting, 'we have received new information about the implants that increases our concern about their safety.'

'Today I am requesting a moratorium on the further use of all silicon gel breast implants until our advisory committee panel ... can reconvene to consider new information on the safety of these devices,' Kessler said.

He said the panel will meet within 45 days.

'Until the panel meets and we have had an opportunity to review its recommendations, I am asking that physicians cease using silicon gel implants,' Kessler said, adding, 'As physicians our first obligation is to do no harm.'NEWLN: more

Kessler also asked manufacturers of the implants 'to stop distributing these products during this period.'

'Given our heightened concern about the safety of the gel implants, I believe the moratorium on further use is the most responsible action that I can take,' Kessler said.

Advertisement

'Our decision does not apply to saline-filled implants, which will continue to be available through the moratorium,' Kessler said.

Last November, the advisory panel's chairmman, Dr. Mary Connell, said, 'We feel these products do represent a public health need. We recommend they remain on the market,' but further scientific study to determine their long-term safety should be required.

The committee rejected safety claims made by four implant makers.

Silcone gel-filled breast implants have been used by about 2 million women for three decades. They were marketed before a law put such devices under FDA regulatory jurisdiction.

Risks associated with the implants include hardening of tissue surrounding the implant, rupturing and interference with mammography screening for breast cancer. Concerns also have been raised about health consequences of silicone leakage.

The FDA advisory committee heard testimony from dozens of witnesses on both sides of the issue. Women who claimed serious health damage from faulty implants urged the FDA to pull the products off the market, while others, including numerous women who were treated for breast cancer, said availability of the implants was in the best public health interest.

Plastic surgeons and cancer support groups said women who were unable to have implants for reconstruction after breast cancer surgery might choose not to have breast cancer treated.

Advertisement

Makers of the implants claimed consumer groups urging a ban based their claims on faulty data.

'A number of individuals and groups have engaged in junk science making sensational claims of adverse effects,' said Dr. Robert LeVier, technical director for Dow Corning Wright, the nation's leading maker of the implants.

Dow Corning Wright, based in Arlington, Tenn., is one of four firms seeking FDA approval of its implants. The firm was reprimanded last week by the FDA for allegedly misleading callers to its information line about the safety of breast implants.

Three other companies -- Bioplasty Inc. of Minneapolis, McGhan Medical Corp. of Santa Barbara, Calif., and Mentor Corp, also of Santa Barbara -- also seek FDA approval for continued marketing of their implants.

Latest Headlines