Lauran Neergaard

“Patients can determine whether or not for them it is worth it to have a device that might need to be replaced within a 10-year period of time,” said Dr. Marilyn Leitch, a cancer surgeon at the University of Texas Southwestern Medical Center.

Mentor hasn’t proved they’ll last even 10 years, argued New York dermatologist Dr. Amy Newburger, who opposed lifting restrictions. Instead, it closely studied patients for just three years and didn’t settle concern about the consequences of silicone leaks.

“I don’t have the assurance that it’s safe,” Newburger said. “My concern was, since hundreds of thousands of patients will be exposed to this, I felt that the urgency (to sell) was not warranted at this time.”

The FDA isn’t bound by its advisers’ recommendations. Just 15 months ago the FDA overruled a recommendation to bring back gel implants, telling manufacturers it needed better data on durability and silicone leakage.

Still, the decision was sure to delight patients who contend silicone-gel implants look and feel more natural than the salt water-filled implants sold without restriction.

“If I had the option today, I would choose silicone over saline,” Arlene Nicole Cummings, a saline implant recipient who runs a Web site for women considering breast implants, told the FDA advisers. “Women, along with their surgeons, should be allowed to choose. … We are neither ignorant nor shallow.”

The decision was a blow to dozens of other women who told the panel of silicone oozing out of their bodies and of years of pain and other symptoms they blame on faulty implants.

“These conditions are unenforceable,” said Sybil Goldrich, a breast cancer survivor who went through four sets of broken implants in the 1980s. “Who’s going to pay for that MRI?”

The advisers acted on “wishful thinking” instead of data, said Cynthia Pearson of the National Women’s Health Network. “How can you ask women to consent based on a lot of unknowns?”

Silicone-gel breast implants began selling in 1962, before the FDA required proof that all medical devices are safe and effective. The FDA imposed its ban on most use of the implants in 1992 amid fears that leaking silicone was dangerous.

Today, gel implants largely have been exonerated of causing serious or chronic illnesses such as cancer or lupus. But aside from the risk of breakage, they can cause infection and painful, rocklike scar tissue.

Mentor’s chief study tracked about 400 women for three years and found 1.4 percent suffered implant ruptures. It also cited 100 patients given Mentor implants by a British doctor, whose own tracking found 5 percent broke within about nine years of insertion.

FDA scientists said Mentor’s data was too limited to settle durability questions and that the British research was skewed because it included only volunteers and excluded patients at highest risk of implant rupture — those with serious scar tissue.

But the advisers found the data reassuring, saying it was supplemented by state-of-the-art mechanical testing that suggests the implants are strong.

The panel harshly criticized Inamed Corp., which had tracked about 900 patients for three or four years to find between 2 percent and 10 percent implant breakage.

The turnaround shocked Inamed Vice President Dan Cohen, who said the panel had made “bizarre and strange decisions” in demanding stricter data from one firm than the other. He said his company would pursue approval.

The two devices are different and Mentor’s studies were better, FDA adviser Stephen Li, a Florida medical device-testing expert, said to explain the differing views.

“We are holding it to higher standards than other implants,” Li said. “This device has a 30-year history that, at best, is checkered. Given that history, it behooves us to have a higher standard.”

About 264,000 breast enlargements and 63,000 breast reconstructions were performed in the United States last year.

But more and more doctors are urging otherwise healthy people to use the pills as a way to prevent heart disease. For them, the findings add another potential complication as they consider whether to tackle their cholesterol with diet and exercise alone or add a medication.

“The statin should not be seen as the magic pill,” says Dr. Yunsheng Ma of the University of Massachusetts Medical School, who led the study of postmenopausal women.

Statins are one of the most widely prescribed drugs, and among the most touted with good reason. They can dramatically lower so-called “bad” LDL cholesterol. Studies make clear that they save lives when used by people who already have heart disease.

What’s debated is how much the drugs help people who don’t yet have cardiovascular disease but whose chances are higher because of other factors such as smoking or high blood pressure — or diabetes. In fact, long-term diabetes is so heart-risky that the American Diabetes Association urges fairly aggressive statin use by many diabetics. For everyone else, Nissen says the general rule is statins help people who have at least a 10 percent chance of a heart attack in the next 10 years, something a doctor can calculate.

All drugs have side effects that are important to consider while deciding whether they’re a good bet for an individual. Statins have long been known to cause muscle pain that on rare occasions becomes a serious breakdown of muscle that can lead to kidney failure, even death.

But whether statins can make blood sugar rise enough that someone crosses the threshold to diabetes has been confusing.

After all, some of the same risks for heart disease — such as being overweight and sedentary — also increase the odds of developing Type 2 diabetes. And Ma says too many statin users wrongly assume the pills will let them eat whatever they want.

Ma’s team examined a huge government study that tracked the health of postmenopausal women for many years. They culled the records of more than 153,000 women who didn’t have diabetes when they enrolled in the Women’s Health Initiative in the 1990s. Just 7 percent were taking statins at the time.

Fast forward to 2005: Nearly 10 percent of the statin users had developed diabetes, compared with 6.4 percent of the older women who hadn’t used the drugs at the study’s start, Ma concluded. The findings were reported online Monday by the journal Archives of Internal Medicine.

This is what scientists call an observational study, which can hint at a risk but can’t prove it.

But it comes after a number of smaller but more precise studies — where patients were randomly assigned to take a statin or some other treatment — that also have found a link. The first to prompt doctor head-scratching was in 2008, a study of the drug Crestor. Last June, a report in the Journal of the American Medical Association analyzed five additional randomized trials and concluded the increased risk was small but real for people taking higher doses of any statin.

That report calculated that one fewer patient would experience a heart attack or other cardiovascular problem for every 155 patients treated for a year — and there would be one additional case of diabetes for every 498 patients treated.

At the National Institutes of Health, diabetes specialist Dr. Judith Fradkin says statins’ benefits outweigh the potential side effect, and that newly developed diabetes won’t harm right away.

“The danger here is alarming people and having them go off a medication that’s of proven benefit,” she says.

But Dr. Beatrice Golomb of the University of California, San Diego, welcomed the new study as a needed note of caution for women, saying there’s less certainty about the drugs’ overall effects in them. Stay tuned: Her own research aims to narrow down which statin users are more likely to experience a blood-sugar jump.

___

EDITOR’S NOTE — Lauran Neergaard covers health and medical issues for The Associated Press in Washington.

But more and more doctors are urging otherwise healthy people to use the pills as a way to prevent heart disease. For them, the findings add another potential complication as they consider whether to tackle their cholesterol with diet and exercise alone or add a medication.

“The statin should not be seen as the magic pill,” says Dr. Yunsheng Ma of the University of Massachusetts Medical School, who led the study of postmenopausal women.

Statins are one of the most widely prescribed drugs, and among the most touted with good reason. They can dramatically lower so-called “bad” LDL cholesterol. Studies make clear that they save lives when used by people who already have heart disease.

What’s debated is how much the drugs help people who don’t yet have cardiovascular disease but whose chances are higher because of other factors such as smoking or high blood pressure — or diabetes. In fact, long-term diabetes is so heart-risky that the American Diabetes Association urges fairly aggressive statin use by many diabetics. For everyone else, Nissen says the general rule is statins help people who have at least a 10 percent chance of a heart attack in the next 10 years, something a doctor can calculate.

All drugs have side effects that are important to consider while deciding whether they’re a good bet for an individual. Statins have long been known to cause muscle pain that on rare occasions becomes a serious breakdown of muscle that can lead to kidney failure, even death.

But whether statins can make blood sugar rise enough that someone crosses the threshold to diabetes has been confusing.

After all, some of the same risks for heart disease — such as being overweight and sedentary — also increase the odds of developing Type 2 diabetes. And Ma says too many statin users wrongly assume the pills will let them eat whatever they want.

Ma’s team examined a huge government study that tracked the health of postmenopausal women for many years. They culled the records of more than 153,000 women who didn’t have diabetes when they enrolled in the Women’s Health Initiative in the 1990s. Just 7 percent were taking statins at the time.

Fast forward to 2005: Nearly 10 percent of the statin users had developed diabetes, compared with 6.4 percent of the older women who hadn’t used the drugs at the study’s start, Ma concluded. The findings were reported online Monday by the journal Archives of Internal Medicine.

This is what scientists call an observational study, which can hint at a risk but can’t prove it.

But it comes after a number of smaller but more precise studies — where patients were randomly assigned to take a statin or some other treatment — that also have found a link. The first to prompt doctor head-scratching was in 2008, a study of the drug Crestor. Last June, a report in the Journal of the American Medical Association analyzed five additional randomized trials and concluded the increased risk was small but real for people taking higher doses of any statin.

That report calculated that one fewer patient would experience a heart attack or other cardiovascular problem for every 155 patients treated for a year — and there would be one additional case of diabetes for every 498 patients treated.

At the National Institutes of Health, diabetes specialist Dr. Judith Fradkin says statins’ benefits outweigh the potential side effect, and that newly developed diabetes won’t harm right away.

“The danger here is alarming people and having them go off a medication that’s of proven benefit,” she says.

But Dr. Beatrice Golomb of the University of California, San Diego, welcomed the new study as a needed note of caution for women, saying there’s less certainty about the drugs’ overall effects in them. Stay tuned: Her own research aims to narrow down which statin users are more likely to experience a blood-sugar jump.

___

EDITOR’S NOTE — Lauran Neergaard covers health and medical issues for The Associated Press in Washington.

But more and more doctors are urging otherwise healthy people to use the pills as a way to prevent heart disease. For them, the findings add another potential complication as they consider whether to tackle their cholesterol with diet and exercise alone or add a medication.

“The statin should not be seen as the magic pill,” says Dr. Yunsheng Ma of the University of Massachusetts Medical School, who led the study of postmenopausal women.

Statins are one of the most widely prescribed drugs, and among the most touted with good reason. They can dramatically lower so-called “bad” LDL cholesterol. Studies make clear that they save lives when used by people who already have heart disease.

What’s debated is how much the drugs help people who don’t yet have cardiovascular disease but whose chances are higher because of other factors such as smoking or high blood pressure — or diabetes. In fact, long-term diabetes is so heart-risky that the American Diabetes Association urges fairly aggressive statin use by many diabetics. For everyone else, Nissen says the general rule is statins help people who have at least a 10 percent chance of a heart attack in the next 10 years, something a doctor can calculate.

All drugs have side effects that are important to consider while deciding whether they’re a good bet for an individual. Statins have long been known to cause muscle pain that on rare occasions becomes a serious breakdown of muscle that can lead to kidney failure, even death.

But whether statins can make blood sugar rise enough that someone crosses the threshold to diabetes has been confusing.

After all, some of the same risks for heart disease — such as being overweight and sedentary — also increase the odds of developing Type 2 diabetes. And Ma says too many statin users wrongly assume the pills will let them eat whatever they want.

Ma’s team examined a huge government study that tracked the health of postmenopausal women for many years. They culled the records of more than 153,000 women who didn’t have diabetes when they enrolled in the Women’s Health Initiative in the 1990s. Just 7 percent were taking statins at the time.

Fast forward to 2005: Nearly 10 percent of the statin users had developed diabetes, compared with 6.4 percent of the older women who hadn’t used the drugs at the study’s start, Ma concluded. The findings were reported online Monday by the journal Archives of Internal Medicine.

This is what scientists call an observational study, which can hint at a risk but can’t prove it.

But it comes after a number of smaller but more precise studies — where patients were randomly assigned to take a statin or some other treatment — that also have found a link. The first to prompt doctor head-scratching was in 2008, a study of the drug Crestor. Last June, a report in the Journal of the American Medical Association analyzed five additional randomized trials and concluded the increased risk was small but real for people taking higher doses of any statin.

That report calculated that one fewer patient would experience a heart attack or other cardiovascular problem for every 155 patients treated for a year — and there would be one additional case of diabetes for every 498 patients treated.

At the National Institutes of Health, diabetes specialist Dr. Judith Fradkin says statins’ benefits outweigh the potential side effect, and that newly developed diabetes won’t harm right away.

“The danger here is alarming people and having them go off a medication that’s of proven benefit,” she says.

But Dr. Beatrice Golomb of the University of California, San Diego, welcomed the new study as a needed note of caution for women, saying there’s less certainty about the drugs’ overall effects in them. Stay tuned: Her own research aims to narrow down which statin users are more likely to experience a blood-sugar jump.

___

EDITOR’S NOTE — Lauran Neergaard covers health and medical issues for The Associated Press in Washington.

But specialists say it can be a risk in more affluent areas, too, as do-it-yourselfers embark on fix-ups without knowing anything about an environmental hazard that long ago faded from the headlines.

The main value of the proposed change may be in increasing awareness of how to avoid lead in everyday life.

“What we need to do is prevent the exposure in the first place,” said Dr. Nicholas Newman, who directs the environmental health and lead clinic at Cincinnati Children’s Hospital.

There are lots of ways people can be exposed to lead: Soil polluted from the leaded gasoline of yesteryear. Old plumbing with lead solder. Improperly using lead-glazed pottery or leaded crystal with food. Certain jobs that expose workers to the metal. Hobbies like refinishing old painted furniture.

Sometimes even imported toys or children’s jewelry can have illegal lead levels, prompting recalls if they’re caught on the U.S. market.

But the main way that U.S. children are exposed is from layers of old paint in buildings built before 1978, when lead was banned from residential paint.

Sure, the walls might have been painted over recently, and there may be no obvious paint chips to attract a tot crawling around on the floor. But friction from opening and closing windows and doors allows tiny leaded particles to make their way into household dust — and youngsters then get it on their hands that go into their mouths, explained Dr. John Rosen, a lead poisoning specialist at the Children’s Hospital at Montefiore in New York City.

Very high lead levels can cause coma, convulsions, even death, fortunately a rarity today. But lower levels, especially in children under 6, can harm a child’s brain, can reduce IQ and cause other learning, attention and behavioral problems — without any obvious symptoms to alert the parent.

How much is too much? Until now, the definition of lead poisoning in young children was 10 micrograms of lead per deciliter of blood. But in a draft report last fall, the National Toxicology Program analyzed recent scientific research to conclude there’s good evidence that levels lower than 10 are a risk. Now advisers to the Centers for Disease Control and Prevention are urging that agency to lower the definition to 5 micrograms for now, periodically reassessing.

If the CDC agrees, its advisers estimated that could classify about 450,000 children with lead poisoning, up from roughly 250,000 today.

At these levels, there’s no treatment for the child other than to end the ongoing exposure — clean up the house, Newman stressed. That’s why prevention is so important. And while the youngest children are the most vulnerable, lead’s not good for anyone’s brain, so he advises taking common-sense precautions before potential exposures like renovating an old home.

What should families do? Here’s advice from the Environmental Protection Agency and public health agencies:

—Check the age of your house. At checkups for babies through age 5, pediatricians are supposed to ask if you live in a home built before 1960, or one built before 1978 that’s recently undergone renovation. The answers help guide who may need a blood test to check lead levels. Some states require testing of toddlers on Medicaid.

—Wash kids’ hands before they eat, good advice no matter where you live or how old your house.

—Clean up paint chips immediately, and regularly wash toys that tots put in their mouths.

—Regularly wash windowsills and floors where paint dust can collect.

—If you’re planning repairs or renovation in an old building, use lead-certified contractors who must follow EPA rules to minimize exposure from the work and can perform quality tests to see if your old paint really contains lead.

—If you rent and have peeling paint, notify your landlord. Many cities and states have lead-abatement rules, and programs to contact for help.

—Aside from paint, take off shoes at the door, to minimize tracking in lead-tainted soil.

—Use only cold water for drinking, cooking and making baby formula, and run it for 15 to 30 seconds. Hot tap water can pick up more lead from older plumbing than cold water.

___

Online:

EPA lead information:

But specialists say it can be a risk in more affluent areas, too, as do-it-yourselfers embark on fix-ups without knowing anything about an environmental hazard that long ago faded from the headlines.

The main value of the proposed change may be in increasing awareness of how to avoid lead in everyday life.

“What we need to do is prevent the exposure in the first place,” said Dr. Nicholas Newman, who directs the environmental health and lead clinic at Cincinnati Children’s Hospital.

There are lots of ways people can be exposed to lead: Soil polluted from the leaded gasoline of yesteryear. Old plumbing with lead solder. Improperly using lead-glazed pottery or leaded crystal with food. Certain jobs that expose workers to the metal. Hobbies like refinishing old painted furniture.

Sometimes even imported toys or children’s jewelry can have illegal lead levels, prompting recalls if they’re caught on the U.S. market.

But the main way that U.S. children are exposed is from layers of old paint in buildings built before 1978, when lead was banned from residential paint.

Sure, the walls might have been painted over recently, and there may be no obvious paint chips to attract a tot crawling around on the floor. But friction from opening and closing windows and doors allows tiny leaded particles to make their way into household dust — and youngsters then get it on their hands that go into their mouths, explained Dr. John Rosen, a lead poisoning specialist at the Children’s Hospital at Montefiore in New York City.

Very high lead levels can cause coma, convulsions, even death, fortunately a rarity today. But lower levels, especially in children under 6, can harm a child’s brain, can reduce IQ and cause other learning, attention and behavioral problems — without any obvious symptoms to alert the parent.

How much is too much? Until now, the definition of lead poisoning in young children was 10 micrograms of lead per deciliter of blood. But in a draft report last fall, the National Toxicology Program analyzed recent scientific research to conclude there’s good evidence that levels lower than 10 are a risk. Now advisers to the Centers for Disease Control and Prevention are urging that agency to lower the definition to 5 micrograms for now, periodically reassessing.

If the CDC agrees, its advisers estimated that could classify about 450,000 children with lead poisoning, up from roughly 250,000 today.

At these levels, there’s no treatment for the child other than to end the ongoing exposure — clean up the house, Newman stressed. That’s why prevention is so important. And while the youngest children are the most vulnerable, lead’s not good for anyone’s brain, so he advises taking common-sense precautions before potential exposures like renovating an old home.

What should families do? Here’s advice from the Environmental Protection Agency and public health agencies:

—Check the age of your house. At checkups for babies through age 5, pediatricians are supposed to ask if you live in a home built before 1960, or one built before 1978 that’s recently undergone renovation. The answers help guide who may need a blood test to check lead levels. Some states require testing of toddlers on Medicaid.

—Wash kids’ hands before they eat, good advice no matter where you live or how old your house.

—Clean up paint chips immediately, and regularly wash toys that tots put in their mouths.

—Regularly wash windowsills and floors where paint dust can collect.

—If you’re planning repairs or renovation in an old building, use lead-certified contractors who must follow EPA rules to minimize exposure from the work and can perform quality tests to see if your old paint really contains lead.

—If you rent and have peeling paint, notify your landlord. Many cities and states have lead-abatement rules, and programs to contact for help.

—Aside from paint, take off shoes at the door, to minimize tracking in lead-tainted soil.

—Use only cold water for drinking, cooking and making baby formula, and run it for 15 to 30 seconds. Hot tap water can pick up more lead from older plumbing than cold water.

___

Online:

EPA lead information: