Researchers at the University of Michigan have used a 3-D printer to create a custom-made, life-saving implant for a baby boy, they report today in a letter in The New England Journal of Medicine.

The baby, Kaiba Gionfriddo, suffered from a rare disorder in which one of the airways in his lungs collapsed when he exhaled. The problem caused him to stop breathing and turn blue when he was only 6 weeks old. Even with a mechanical ventilator, Kaiba stopped breathing virtually every day, requiring doctors to perform emergency resuscitations.

“We’d recently had a child in the hospital who died of this, and I said, ‘there has got to be a solution that we can find for these kids,’ ” says co-author Glenn Green, Kaiba’s doctor and an associate professor of otolaryngology.

So Green and his Michigan colleagues tried something new.

Using a 3-D printer, they custom-built a tiny, flexible splint that will grow with Kaiba. Researchers used a special material designed to be absorbed by Kaiba’s body in about three years, says co-author Scott Hollister, a professor of biomedical and mechanical engineering.

Instead of making a cast of Kaiba’s airway with plaster, they used a CT scanner, which gave them a 3-D blueprint.

Like a vacuum-cleaner hose, the C-shaped splint is flexible enough to move when Kaiba breathes. But it’s also firm enough to prevent his air tube from flopping shut, says Green.

Kaiba was able to come off the ventilator three weeks after his surgery in February 2012. “Our prediction is that this will be a cure for him,” Green says. “The splint will go away and the process will be done.”

The porous splint is made from the same material as dissolvable stitches, Green says. Just as a wisteria vine grows through a trellis, Kaiba’s body will create new cells to permeate the scaffold. By the time the splint is completely absorbed, doctors hope that Kaiba’s own tissue will be sturdy enough to keep his airway open.

By then, Kaiba will be big enough to withstand a slight narrowing of the bronchus, Green says. As a newborn, the bronchus was so narrow that even a slight collapse was enough to completely block air flow.

About one in 2,200 babies are born with Kaiba’s condition, called tracheobronchomalaci. Most grow out of it by age 2 or 3.

Now 19 months old, Kaiba is breathing well, although he still has a tracheostomy tube, which allows air into his windpipe, says his mother, April Gionfriddo, of Youngstown, Ohio.

“We’re really relieved and happy that he’s not turning blue anymore,” says Gionfriddo, noting that Kaiba has battled multiple complex health problems, including a hernia, asthma and anatomic defects in several blood vessels. He also underwent surgery to treat hydrocephalus, in which fluid presses on the brain.

Other surgeons praised the Michigan team’s ingenuity.

“It’s hugely fascinating,” says Sidhu Gangadharan, chief of thoracic surgery at Beth Israel Deaconess Medical Center in Boston, who wasn’t involved with Kaiba’s care. “They had a really unique problem and they came up with a unique solution.”

Gangadharan says his hospital will likely follow the researchers’ example in custom designing medical devices with 3-D printers Because Kaiba’s life was in immediate jeopardy, the Food and Drug Administration gave doctors emergency clearance to produce the device. The 3-D printer allowed doctors to design and produce the splint quickly, Hollister says. The printers work somewhat like inkjet printers. But instead of squirting out layers of ink, the printer lays down layers of the biopolymer.

Doctors are now planning a clinical trial in order to create additional splints for children whose condition isn’t immediately life-threatening.

The same technology could be used to custom engineer a variety of implants, such as facial bones, Hollister says. He and Green already have built ears and noses, based on patient scans, although these have not yet been transplanted into people.

Scientists are already using 3-D printers to build scaffolds for tissue engineering, with the aim of making blood vessels and other replacement body parts, says Anthony Atala, the Director of the Wake Forest Institute for Regenerative Medicine in North Carolina.

Atala uses a 3-D printer to lay down a cell-filled gel, layer by layer. The gel protects the cells from being damaged in the printing process, but it also hardens into a scaffold, Atala says. Substances in the gel provide food for the cells to grow.

These custom-made blood vessels — so far used only in animals — could be used in bypass surgery, Atala says. They could also be used to replace blocked blood vessels in the legs, or provide blood vessels to patients undergoing kidney dialysis. Atala also has used tissue engineering to create bladders for patients.

Researchers are also using these techniques to develop cartilage-based organs such as ears and tracheas. Researchers at Princeton University recently used a 3-D printer to create a functional bionic ear.

In April, doctors at the University of Illinois in Peoria gave a 2-year-old girl a new windpipe, which was grown from stem cells seeded on a plastic scaffold.

Copyright © 2013 USA TODAY, a division of Gannett Co. Inc.

He didn’t know the gun was loaded.

The 14-year-old Massachusetts boy had recently found his mother’s handgun, which she kept hidden under her mattress for protection.

“Promise me you’ll never touch it,” his mother, a single mom, had asked him.

But the lure of the gun was irresistible. He decided to show it off to his neighbor, 12-year-old Brian Crowell.

“He was going, ‘Click, click, click,’” pretending to shoot the gun, says Brian’s mother, Ann Marie Crowell, who spoke to the child and his mother after the incident. “But there was one last bullet. It went into Brian’s neck.”

And just like that, Crowell’s son was gone.

Nearly 800 children under 14 were killed in gun accidents from 1999 to 2010, according to the Centers for Disease Control and Prevention. Nearly one in five injury-related deaths in children and adolescents involve firearms.

Although mass shootings get more attention, children are far more likely to be killed at home.

Through homicide, suicide and accidents, guns cause twice as many deaths in young people as cancer, five times as many as heart disease and 15 times as many as infections, according to the American Academy of Pediatrics.

And while Congress voted down gun legislation last month, children’s advocates such as Crowell are urging parents and communities to take their own steps to protect kids.

Crowell, who attended the State of the Union address in January as President Obama’s guest, has devoted her life to gun safety, urging parents to ask whether there are guns in the home before sending their kids for playdates.

“I had never thought to ask about guns in the home,” says Crowell, of Saugus, Mass.

Saugus says she’s aiming for common sense, not sweeping political change. Nearly 40% of American households have guns, studies show.

“If I owned a gun, I wouldn’t be mad that someone asked,” Crowell says. “If you were going over for a playdate to a house with a swimming pool, wouldn’t you want them to lock the pool gate? As a parent, you want to do anything you need to do to protect your child.”

The American Academy of Pediatrics recommends that pediatricians include a question about guns in the home when taking a patient’s history.

“It’s no different than when we ask about safety seats in the car or bicycle helmets, or the temperature of your hot water heater,” academy president Thomas McInerny says. “We want to keep children safe. And most parents say they appreciate it.”

If a child’s parents own guns, pediatricians should counsel them about the need to store them safely, the academy says. Its policy statement on guns says, “The safest home for a child or adolescent is one without firearms.”

Research shows that storing guns locked and unloaded reduces the risk of both injuries and suicide by about 70%, according to a 2005 study in the Journal of the American Medical Association.

Bill Brassard, a spokesman for the National Shooting Sports Foundation, says, “Safe storage is absolutely critical to preventing the misuse of firearms.”

People who want quick access to a gun for security can still store them safely, Brassard says, with lockable boxes that can be opened with a keypad. Most major firearm manufacturers now include a gun lock with new guns, Brassard says.

Yet many fail to follow such advice.

About 29% of households with children under 12 fail to lock up their guns, according to a 2006 study in Archives of Pediatrics and Adolescent Medicine by Harvard’s David Hemenway and others.

Some see the pediatrics academy’s policy as a threat to gun owners’ rights.

In the past two years, six states have considered bills to prevent doctors from asking about guns in the home or recording that information into medical records. Only Florida’s bill passed. That law never went into effect, however, because it was blocked by a judge.

Some of the USA’s largest firearms organizations run gun safety programs.

The National Shooting Sports Foundation says its 12-year-old ChildSafe program has distributed 35 million free firearm safety kits that include a gun locking device and firearm safety brochure.

National Rifle Association spokesman Andrew Arulanandam says 18 million children have participated in the NRA’s Eddie Eagle GunSafe Program. The program teaches kids, “If you see a gun, STOP! Don’t Touch. Leave the Area. Tell an Adult.”

“The one thing we always recommend is education,” Arulanandam said. “You have to teach your children that guns aren’t toys.”

Arulanandam notes that gun deaths among adolescents have fallen sharply. In 1994, the rate of all firearms-related deaths in teens 15 to 19 years old peaked at 28 deaths per 100,000 people. Declining homicide rates helped lower that rate to 11 deaths per 100,000 people in 2009, according to the CDC.

Fewer children are dying from gun accidents today than a decade ago, as well. The number of kids under 14 who died in a gun accident fell from 86 in 2000 to 62 in 2010, according to the CDC. Yet progress has been uneven. Among the youngest children — those under age 4 — the number of accidental gun deaths more than doubled, to 25 a year in 2010.

Arulanandam credits programs like Eddie Eagle for helping to reduce deaths in children. Yet Arthur Kellermann, a policy analyst at Rand Corp., said programs such as Eddie Eagle have never been independently assessed to measure whether they really make kids safer. He worries that gun safety programs could give parents a false sense of security.

Most parents believe their child is smart enough not to touch a gun, surveys show. Studies prove them wrong, Kellermann said.

In an experiment in which researchers observed how 8- to 12-year-old boys behaved when left alone in a room with a hidden gun, 75% of boys found the gun within 15 minutes. Only one of 64 kids in the experiment left the room to notify an adult. The gun was modified so it couldn’t fire.

Of the boys who found the gun, 63% handled it and 33% pulled the trigger.

More than 90% of boys who handled the gun or pulled the trigger said they had received some sort of gun safety instruction, says Kellermann, co-author of the study, published in Pediatrics in 2001.

“Although I have no doubt that the (NRA) program is well intended, I worry that it may foster a sense of complacency among gun-owning parents, that it’s OK to keep a gun loaded and readily available for protection because their child will respect it,” Kellermann says. “Even kids who’ve been taught gun safety are naturally curious.”

Guns also should be designed more safely, Kellermann says.

If manufacturers can make childproof aspirin bottles, they should be able to make a gun that can’t be operated by a child, says Hemenway, director of the Harvard Injury Control Research Center.

Guns also should be redesigned so that they don’t go off accidentally when dropped, Hemenway says.

“What I don’t understand is why the industry hasn’t done more to make handguns childproof, since we have no evidence to date that it is possible to make children gun-proof,” Kellermann says. “And as recent tragedies have proven, they are not bullet-proof.”

Copyright © 2013 USA TODAY, a division of Gannett Co. Inc.

Tanning beds could soon come with a warning label, alerting users to the risk of skin cancer and noting that the devices shouldn’t be used by people under 18.

Those changes could come through a new proposal from the Food and Drug Administration, which today announced plans to change the way that the sunlamps used in tanning beds are regulated.

Today, these tanning lamps, which emit ultraviolet radiation, are regulated as “low-risk,” class 1 devices, in the same category as tongue depressors and Band-Aids. These products aren’t required to be reviewed before going on the market, said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.

Under the proposed change, tanning lamps would be considered class 2 devices, in the same category as CT scanners, which also expose people to radiation, Shuren said.

If the proposed order is finalized, “There will be requirements that products have to meet in order to go on the market,” Shuren said. Tanning machines also will warn customers not to use them if they have skin cancer or open skin lesions, or if they have a family history of skin cancer.

An FDA advisory panel first suggested making the change in 2010, Shuren said.

Reviewing tanning machines before they’re sold would help the FDA ensure they’re working safely, Shuren said.

Shuren said he’s concerned about software problems in the machines that make timers malfunction, causing people to get excess radiation, and electrical failures that have led to customers getting burned.

Research shows that 58% of teens who use tanning beds get sunburned, along with 66% of female college students, Shuren said. Researchers found that these college students got burned one in every five times that they tanned.

“You’re supposed to be able to tan without burning in these machines,” Shuren said.

Tanning lamps expose people to 10 times as much ultraviolet light as the sun, Shuren said. The World Health Organization classifies ultraviolet light as a carcinogen, in the same category as cigarette smoke.

Just one session in a tanning booth increases the risk of melanoma by 74%, Shuren said.

In a statement, the American Suntanning Association, which represents tanning salon owners, said, “The professional sunbed community has not had any input in this preliminary proposal thus far. We remain dedicated to sunburn prevention and look forward to working with the FDA to improve consumer protection and to assure that all information regarding indoor tanning is in accordance with the science.”

Physician Mary Maloney, a spokeswoman for the the American Academy of Dermatology, said, “We couldn’t be happier. We are proud and pleased.”

Ultimately, Maloney said she would like to see the FDA prohibit children under age 18 from using tanning beds. “This is a starting point,” Maloney said. “There is more work to be done.”

California and Vermont already prohibit minors from using tanning beds, as do the cities of Chicago and Springfield, Ill. New York and New Jersey ban children under age 17 from using tanning beds.

About 2.3 million teens use tanning beds every year, said Maloney, noting that the USA is in the peak of tanning season, as girls get ready for the prom and women prepare for spring weddings.

Maloney blames tanning beds for much of the recent increase in melanoma among young women. Melanoma, the deadliest form of skin cancer, is now the most common form of cancer among people ages 25 to 29.

Copyright © 2013 USA TODAY, a division of Gannett Co. Inc.

Nearly 20% of children and young people at risk for suicide say there’s a gun in their home, new research shows.

And among these youth, 15% know how to get their hands on both the gun and bullets.

“That’s a volatile mix: kids at risk and the means to complete suicide,” said Stephen Teach, who will present the study Monday at a meeting of the Pediatric Academic Societies in Washington.

Pediatricians devoted special attention to gun violence at the meeting, including a special symposium Saturday. Thomas McInerny, president of the American Academy of Pediatrics, also focused on gun violence in his plenary address.

More than 1,900 young people in the U.S. ages 5 to 19 committed suicide in 2010. Nearly half of these suicides involved firearms, said Matthew Miller, an associate professor at the Harvard School of Public Health, who spoke at the symposium. Suicide is the third-leading cause of death among teens ages 15 to 19, according to the Centers for Disease Control and Prevention (CDC).

In Teach’s study, doctors interviewed 524 young people ages 10 to 21 who were treated in pediatric emergency rooms, either for a physical or psychiatric health issue.

These findings may actually underestimate the real risk, said Miller, who wasn’t involved in the survey.

Research suggests that about one-third of children live in homes with a firearm, Miller said. And about 1.5 million children live in a household where guns are kept loaded and unlocked, Miller said. It’s possible that some young people interviewed for the survey were unaware that their parents own guns.

Guns are the most lethal form of suicide. According to the CDC, 85% of suicide attempts with guns prove fatal, compared with 1% to 2% of attempts made by slashing one’s wrists or taking pills.

Reducing teens’ access to guns can be life-saving, Miller said. Studies show that many teen suicide attempts are impulsive. One-fourth of teens who survived a suicide attempt said they thought of suicide just five minutes before making the attempt.

For many people, suicide is a passing urge. Fewer than 10% of those who survive a suicide attempt go on to kill themselves, Miller said.

The findings underscore the importance of screening young people for depression and suicidal thoughts, as well asking about guns in the home, said Teach, associate chief of emergency medicine at Children’s National Medical Center in Washington, D.C.

Teach and his colleagues have developed a four-item questionnaire that can be used to screen all teens who come into the ER or primary practice clinics.

Screening all teens is important, because up to 40% of youths who kill themselves have no known mental illness, said study co-author Jeffrey Bridge, an associate professor of pediatrics at Ohio State University. In the survey, doctors found that nearly half of young ER patients with psychiatric complaints were at risk for suicide, as were about 10% of those who had a medical or surgical issue.

According to research by the CDC, 8% of high school students have attempted suicide in the past year. In comparison, less than 1% of adults ages 18 to 54 have attempted suicide in the past 12 months.

The American Academy of Pediatrics recommends that doctors ask children’s families about guns in the house and talk about ways to keep kids safe, McInerny said.

The National Shooting Sports Foundation agrees about keeping guns secured, spokesman Bill Brassard said. Parents should store firearms locked, unloaded and stored separately from ammunition, which also should be locked, he said.

Research shows that keeping a gun in the home increases the risk of suicide by nearly five times, Miller said.

Yet educating parents about the risk of guns and suicide can help.

In a survey of 106 parents of severely depressed adolescents, doctors asked if there were guns in the home and, if so, counseled parents about safety.

Two years later, 27% of the parents who received the counseling had taken the guns out of their homes. Among parents who weren’t counseled — because they didn’t own guns at the time of the interview — 17% acquired guns.

In the past two years, six states have considered bills to prevent doctors from asking about guns in the home or recording that information into medical records. Only Florida’s bill passed. That law never went into effect, however, because it was blocked by a judge.

Copyright © 2013 USA TODAY, a division of Gannett Co. Inc.

In a major break from the past, a leading medical group is advising men to think carefully before getting getting screened for prostate cancer.

The American Urological Association, which has staunchly defended the PSA screening test in recent years, says healthy men under 55 don’t need routine annual screening. And men ages 55 to 69 who are considering the PSA should consult their doctors about the test’s benefits and risks, according to a new policy announced Friday. Until now, the group had advised healthy men ages 40 and up to ask their doctors about the PSA.

Authors of the new guidelines “learned very quickly that there really was no high-level evidence supporting the use of screening with PSA,” says urologist H. Ballentine Carter, who chaired the panel that wrote the new guidelines.

Some men and their doctors may be reluctant to stop screening, says Carter, a professor at Johns Hopkins University School of Medicine in Baltimore.

“The public is very enthusiastic about screening, partly because of our messaging,” Carter says. “The idea that screening delivers benefits may have been overexaggerated.”

But Carter notes that “if a physician and patient sit down and the patient really, really understands the risks and benefits, then it’s been absolutely proven that a substantial minority will not choose to be screened.”

Given the limited benefits of the PSA, and the risks from cancer treatment, the urology group doesn’t recommend PSA screening for men 70 and older who are expected to live less than 10 to 15 more years.

Men with prostate pain or other problems should still talk to their doctors about their symptoms, the group says. Younger men at high risk of prostate cancer should also ask their doctor’s advice. Men at higher risk include African Americans and those with a very strong family history of prostate cancer, defined as cancer that develops before age 50, in multiple first-degree relatives, such as fathers or brothers, Carter says.

“It’s a big change,” Carter says. “An obvious questions is, ‘Why is the (urology group) all of a sudden changing their stance?’”

Urologists have mostly continued to promote the PSA, even as other medical groups have backed away from recommending the blood tests. Last year, the urology group harshly criticized a federal expert panel that suggested men avoid the PSA entirely.

Carter notes that the group’s 2009 “best practices” statement, which encouraged PSA testing, was based on a consensus of expert opinion.

The new guidelines were based strictly on medical evidence from rigorously designed clinical trials, Carter says. Urologists considered the same evidence used by the federal panel, the U.S. Preventive Services Task Force. Urologists also followed standard guidelines for making health recommendations, set out by the Institute of Medicine, he says.

“This was a much more sound scientific process,” says prostate surgeon Peter Scardino, chair of the surgery department at New York’s Memorial Sloan-Kettering Cancer Center.

Research suggests that PSA screening may prevent one death from prostate cancer for every 1,000 men screened over a 10-year period, the urology group says. Yet many men who undergo PSA screening will be harmed, because of treatments that can lead to incontinence or impotence. Even undergoing a prostate biopsy, in which prostate tissue is removed with needles, puts men at risk for being hospitalized for an infection or other complication.

The urologists’ stance on prostate cancer screening is now more in line with that of the American Cancer Society and five other medical groups, which emphasize “shared decision-making” — they advise men to talk to their doctors about the risks and benefits of PSA. Three medical groups, including the U.S. Preventive Services Task Force, advise men to skip screening.

The new recommendations are a “radical change,” but a welcome one, says Michael Palese, associate professor of urology at the Icahn School of Medicine at Mount Sinai, who was not involved in writing them.

“It will help to change the current climate of over-biopsy and overreaction when it comes to PSA,” Palese says. “On the other hand, we do need to continue to keep a vigilant watch on those patients who have prostate cancer that should be treated and will benefit from treatment.”

Otis Brawley, the American Cancer Society’s chief medical officer, says the urology group’s official statement on screening has always been more nuanced than many people — including its members — realized. That’s led many individual urologists to strongly promote the PSA to patients, while minimizing the risks.

“Some of the doctors just don’t understand the technical issues in screening and don’t understand what the risks are,” Brawley says.

Copyright © 2013 USA TODAY, a division of Gannett Co. Inc.

BOSTON — Melanie Perkins McLaughlin was sitting in a stranger’s living room, 20 weeks pregnant and filled with fear. Only days earlier, she had learned that her much-wanted baby — conceived after two miscarriages — had Down syndrome.

Doctors had made the diagnosis by first screening McLaughlin with a test that analyzes proteins and hormones in a woman’s blood. Her results were confirmed with an amniocentesis, an invasive procedure that allows doctors to analyze cells from amniotic fluid.

Doctors gave McLaughlin the option to terminate but told her she would have to decide quickly. Massachusetts allows abortion up to 24 weeks of pregnancy.

“It was a heartbreaking decision,” says McLaughlin, of Medford, Mass.

She wondered whether she was up to the task of raising a child with Down syndrome, which causes intellectual disabilities, low muscle tone and other complications. “It was one of the loneliest times.”

While prenatal tests have been available since the 1970s, rapid technological advances are opening up a new era, doctors say — one in which couples have an unprecedented glimpse of the forming child, and with this new information an often-wrenching choice: proceed with the pregnancy or terminate it.

The American College of Obstetrics and Gynecology now recommends offering prenatal testing to all pregnant women, although it says the most sophisticated tests should be reserved for those at high risk.

Because some new screenings are non-invasive — involving a blood draw instead of long needles in the belly — they’re likely to appeal to far more women, says medical geneticist Brian Skotko. Today, only 2% of pregnant women opt for invasive prenatal procedures. Next-generation screenings have broader appeal because they can be done early in pregnancy, without risk to the fetus, he says.

Though these scientific advances give doctors and parents an early window on the fetus and enable medical teams to anticipate complications, the tests also usher in a world of uncertainty that could affect millions of couples in the coming years.

Women who sign up for a simple blood test could, a few weeks later, find themselves considering whether to terminate their pregnancy, says Skotko, co-director of the Down syndrome program at Massachusetts General Hospital. As McLaughlin found, these decisions are particularly difficult because they come not long after couples are hit with the initial shock and grief of a frightening diagnosis.

“When families get a diagnosis prenatally, they use the words ‘shock,’ ‘sadness,’ ‘disbelief,’ ” says Sarah Cullen, family support director for the Massachusetts Down Syndrome Congress. “You feel like the rug is pulled out from under you. You feel very heavy. You feel very, very alone.”

EARLIER AND EARLIER DIAGNOSES

The past couple of years have seen several major breakthroughs:

• Non-invasive fetal DNA tests. Over the past 18 months, four companies have begun marketing screenings that measure “cell-free” fetal DNA, which circulates freely in a pregnant woman’s blood. The first to enter the market, Sequenom, says it has processed 100,000 of its MaterniT21 tests for Down syndrome.

These blood tests can detect Down syndrome with about 99% accuracy nine weeks into pregnancy. Because of the small risk of error, positive results are confirmed with an amnio or chorionic villus sampling (CVS), which analyzes cells from the placenta. Amniocentesis is typically performed between 15 and 20 weeks, while CVS can be done between nine and 12 weeks.

• Mapping the fetal genome. Last year, scientists proved that an entire fetal genome, or genetic blueprint, can be sequenced with just a sample of the mother’s blood. While that level of analysis is not yet available to the public, the technique could allow doctors to look for countless genetic conditions. Analyzing cell-free fetal DNA “is likely the first of major steps” toward routinely sequencing the fetal genome, according to a statement released in April by the American College of Medical Genetics and Genomics.

• Microarrays. Another new test, a chromosomal microarray, is five times as sensitive as the traditional analyses used with amnio or CVS. Traditional tests involve looking at chromosomes under a microscope. Microarrays use computer chips to detect sections of DNA that are either deleted or repeated in unusual ways. In a December study, microarrays found genetic problems in 1.7% of the fetuses of women at high risk because of their age or other issues. Study authors said doctors should consider offering the procedures to all women, not just those at high risk.

While the medical community is largely cheering these advances, some opponents of abortion see the new technology as a threat, and they’re responding by restricting when women can terminate a pregnancy.

Advocates for the disabled are also concerned, fearing that women may end pregnancies based on misinformation or myths.

Many women are unprepared for these choices, says Ruth Faden, director of the Johns Hopkins Berman Institute of Bioethics. And even as the science leaps ahead, she says, the basic ethical dilemma of prenatal testing hasn’t changed.

“This technology has not given us some way to magically prevent the condition or cure the baby,” Faden says. “The pregnancy will be terminated or the baby will be born with it.”

Some now wonder whether people with Down syndrome eventually will disappear from society, Skotko says, even as medical and educational advances allow them to lead longer, healthier lives than ever before.

“What kinds of life do we consider valuable?” asks Skotko, whose younger sister has Down syndrome. “And who gets to decide that? Is it the state? Or is it the individual?”

WHAT TO DO?

McLaughlin says she couldn’t make the decision alone.

She and her husband sought out another family that had been in their shoes, hoping to learn what’s involved in parenting a child with Down syndrome. Their meeting with the family of 5-year-old Anna Burtnett was arranged through First Call, a program in which volunteers open their doors to couples who have just received a diagnosis.

Minutes after McLaughlin arrived at her home, Anna was playing hide-and-seek with McLaughlin’s children.

“It was the first time that I thought, maybe this isn’t the end of the world, that maybe it would be OK,” McLaughlin says.

In some ways, medicine’s ability to map out a person’s genetic identity is outpacing society’s understanding of what it means to live with a disability, or raise a child with one, says G. Kevin Donovan, a pediatrician and director of the Edmund Pellegrino Center for Clinical Bioethics at Georgetown University in Washington.

The availability of prenatal tests has led to a sharp drop in birth rates in babies with Down syndrome, studies show. Between 60% to 90% of women who receive a prenatal Down syndrome diagnosis end the pregnancy, according to a 2012 analysis of 24 studies in Prenatal Diagnosis.

A small number of families that proceed to birth give the child up for adoption, says Stephanie Thompson, assistant director of the National Down Syndrome Adoption Network. The Cincinnati-based group keeps a registry of 200 families who want to adopt a child with Down syndrome.

Ronald Wapner of Columbia University Medical Center in New York, a lead author of the microarray study, sees new prenatal tests as an important advance. By detecting genetic irregularities linked to autism, for example, microarrays could give parents advance notice that their baby might need early intervention.

Some couples with a high risk of inherited conditions also might not otherwise try to conceive, he says. Microarrays could allow such couples to become parents.

“I think it unfair to call this a dilemma,” Wapner says. “Some parents want as much information as they can. Not having the information would be a dilemma for them.”

IMPLICATIONS OF TESTS

The timing of prenatal tests has become critical — both for medical and political reasons.

Early screenings could be a boon to women’s health, by allowing women with negative results to avoid further invasive tests, says Matthew Rabinowitz, CEO of Natera, a California company that makes a fetal DNA screening.

Women with confirmed positive results would have the option of an earlier abortion, which poses fewer risks to women, Rabinowitz says.

Earlier this year, Arkansas banned most abortions after 12 weeks, a point in pregnancy at which many women have not yet had time to undergo prenatal screenings or learn their results.

In March, North Dakota became the first state in the USA to ban abortions in the case of genetic conditions such as Down syndrome. While the law doesn’t mention prenatal testing, it states that a doctor may not perform an abortion if a pregnant woman wants the procedure because of a fetal condition. The law also virtually bans abortions by making them illegal after a fetal heartbeat can be detected. That can be as early as six weeks.

Several states — Massachusetts, Virginia, Kentucky and Missouri — have passed laws requiring that women with a prenatal Down syndrome diagnosis receive “accurate, up-to-date” information about the condition.

In Massachusetts, that information includes the number to the First Call program, which rings to Cullen’s cellphone. Other states have similar programs, also run by Down syndrome groups.

Cullen describes the First Call program as neither pro-life, nor pro-choice, but “pro-information.” Her group gets no funding from anti-abortion organizations.

Many parents of children with Down syndrome complain that their doctors gave them inaccurate or outdated information, Skotko and other researchers say. Some moms report being told that their child would never live on his own, hold a job or even be able to make change for the bus.

And doctors who offer prenatal testing often have little training in Down syndrome, Skotko’s research shows. Many are unprepared to counsel couples about what it means to raise a child with this kind of disability.

For many couples, the challenges of raising a child with Down syndrome seem overwhelming. Half of babies are born with congenital heart defects, which often require surgery. Children with Down syndrome have low muscle tone, so they may not learn to walk or talk in sentences until age 3 or 4. Adults with Down syndrome have an increased risk of life-long complications, from thyroid problems to early Alzheimer’s.

Yet Faden, the bioethicist, says few people can accurately predict how they will react even process such a daunting diagnosis.

Although many people anticipate feeling devastated by a serious medical condition, most are more resilient than they imagine, Faden says. After an initial period of shock, most people adapt, and “rate their quality of life as just as good as before,” Faden says.

“With parenting, you may think, ‘This is going to be beyond my ability to cope,’ ” Faden says. “But then the child is born and life is good — not perfect and maybe not according to plan — but good.”

COMING TO TERMS

In the end, McLaughlin chose to continue her pregnancy. Her daughter, Gracie, is now 5.

“If I could go back, I wish I could tell myself not to be so afraid,” says McLaughlin, now 46. Having a baby with Down syndrome “wasn’t a bad thing. It was a very good thing.”

Even so, coming to terms with Down syndrome took time. McLaughlin says she waited eight hours after Gracie’s birth before visiting her in the neonatal intensive care unit.

Gracie’s heart surgery at 2 months was a “wake-up call,” says McLaughlin, a documentary filmmaker. “I had to hand her over to a doctor, not knowing if I would get her back.”

Today, McLaughlin is a passionate advocate for Gracie, as well as a volunteer with the First Call program. McLaughlin has made a series of videos about life with Down syndrome for the National Down Syndrome Society, which debuted in March.

McLaughlin says she respects the couples who visit her home, no matter what they decide.

“I would never in a million years judge them,” McLaughlin says. “Who is anybody else to judge somebody in that situation? Even if you’ve been in that position, with a prenatal diagnosis, everyone is an individual and every situation is different.”

One mother cried after seeing Gracie in person, McLaughlin says. The mother, suffering from postpartum depression, had learned her son’s diagnosis just after delivery.

“I said, ‘It’s OK. I know you look at her and see Down syndrome,’ ” McLaughlin says. ” ‘I look at her and see this wonderful toddler. You’ll get there, too.’ “

Copyright © 2013 USA TODAY, a division of Gannett Co. Inc.

Women and girls age 15 and over will soon be able to buy emergency contraception without a prescription.

The Food and Drug Administration announced on Tuesday that it was approving Plan B One-Step, also known as the morning-after pill, to be sold in the retail aisle next to other over-the-counter medications. Customers will not have to ask a pharmacist for it.

FDA officials say the announcement is unrelated to a federal judge’s order earlier this month, which gave the agency 30 days to make the pill available to all girls and women without a prescription, regardless of age.

Until now, women have had to ask a pharmacist for emergency contraception. Those under 17 could get the pill only with a prescription.

In his April 5th ruling,U.S. District Court Judge Edward Korman noted that emergency contraception has been shown to be extremely safe, and that the FDA’s age limits were arbitrary.

“FDA has engaged in intolerable delays,” Korman said, amounting to an “administration agency filibuster.”

Korman’s ruling was in response to a lawsuit by the Center for Reproductive Rights, which sued to expand access to emergency contraception, which can prevent pregnancy if taken within three days of unprotected sex or contraceptive failure.

Plan B One-Step, a single pill containing a hormone found in birth control pills, sold by Teva Women’s Health, does not terminate an existing pregnancy and does not harm a developing fetus, the FDA said.

About half of pregnancies are unintended, studies show.

FDA spokeswoman Erica Jefferson said the Tuesday approval “is independent of the judge’s ruling and is not intended to address it.”

In an interview with USA TODAY’s Editorial Board last week, FDA Commissioner Margaret Hamburg said the agency had not yet decided how to respond to the judge’s order. Jefferson said the Department of Justice handles litigation, and said all questions about the judge’s order should be referred to that agency.

Now, customers will be able to buy Plan B One-Step just as they would purchase condoms. But girls will have to show an ID to prove their age, the FDA said.

“The FDA is under a federal court order that makes it crystal clear that emergency contraception must be made available over the counter, without restriction to women of all ages by next Monday,” said Nancy Northup, president and CEO of the Center for Reproductive Rights, in a statement.

“Lowering the age restriction to 15 for over-the-counter access to Plan B One-Step may reduce delays for some young women — but it does nothing to address the significant barriers that far too many women of all ages will still find if they arrive at the drugstore without identification or after the pharmacy gates have been closed for the night or weekend. These are daunting and sometimes insurmountable hoops women are forced to jump through in time-sensitive circumstances, and we will continue our battle in court to remove these arbitrary restrictions on emergency contraception for all women.”

Emergency contraception has had a long history with the FDA. The drug was first approved in 1993.

In 2011, the FDA was about to approve an application from its manufacturer, Teva Women’s Health, to sell it over the counter. President Obama expressed concerns, however, and Secretary of Health and Human Secretary Kathleen Sebelius overruled the FDA.

When its application to sell Plan B One-Step over-the-counter without age restrictions was rejected, Teva submitted a new application, requesting approval for those 15 and up, the FDA said.

That application, asking for approval for those 15 and up, was filed before the judge’s ruling, Jefferson said.

At the time of the judge’s ruling, the Family Research Council’s Anna Higgins said, “Making Plan B available for girls under the age of 17 without a prescription flies in the face of medical information and sound judgment.”

Higgins also expressed concern that the over-the-counter availability of Plan B for girls of any age would put many at further risk of sexually transmitted infections.

In a statement, Planned Parenthood Federation of America officials praised the FDA’s decision, although the group also encouraged the FDA to lift all restrictions on emergency contraception, as mandated by the court.

“While there are still practical questions to resolve, this is an important step forward to expand access to emergency contraception and for preventing unintended pregnancy,” Planned Parenthood President Cecile Richards said. “This decision will eliminate some of the biggest barriers and hurdles that women face in getting emergency contraception when they need it, which means many more women will be able to prevent unintended pregnancy.”

Other forms of emergency contraception have been approved. A two-dose version of Plan B is available generically and available to women 17 and up without a prescription. It requires a prescription for girls under age 17. Another version, sold as Ella, is sold only with a prescription and is approved to prevent pregnancy within five days of unprotected sex or contraceptive failure.

Copyright © 2013 USA TODAY, a division of Gannett Co. Inc.

“Arm lifts” have become one of the fastest-growing varieties of plastic surgery, a new study shows.

More than 15,000 women underwent an arm lift in 2012, an increase of more than 4,000% since 2000, according to a report out Monday from the American Society of Plastic Surgeons.

The popularity of the procedures isn’t driven by a desire to look as good as Michelle Obama does in a sleeveless sheath.

Instead, the surgeries are growing because more people are losing massive amounts of weight, usually through obesity surgery, says David Reath, a plastic surgeon in Knoxville, Tenn., and chairman of the public education committee for the plastic surgeon society.

About 200,000 Americans a year undergo some kind of weight-loss procedure, such as gastric bypass, says Jack Fisher, president of the American Society for Aesthetic Plastic Surgery, from Nashville.

While surgery can help people lose weight and fat, it doesn’t decrease the amount of skin, Reath says. People who lose 100 pounds or more can be left with a lot of extra skin.

“Once skin is stretched out, it becomes like a broken rubber band,” Fisher says. “Even when you lose weight, the skin doesn’t go back to its normal shape.”

Patients sometimes refer to this extra skin as “bat wings,” Reath says. Depending on a patient’s weight loss and body type, some also opt for surgery to remove extra skin from the abdomen or all around their mid-section, a procedure called a “body lift.”

The extra skin can make it harder for patients to wear clothes — or enjoy their new look, Reath says.

“When they see themselves in the mirror, they don’t see themselves at an appropriate weight,” Reath says.

The number of cosmetic surgeries increased by 3% last year, to nearly 1.7 million, according to the American Society for Aesthetic Plastic Surgery. When non-surgical options such as botox injections are included, Americans had more than 10 million cosmetic procedures last year.

Arm lifts aren’t for everyone.

The surgeries can cost $5,000 or more out-of-pocket, Fisher says. And they leave patients with a scar that stretches from their elbow to their armpit.

Doctors say women who want to look like the first lady will have to earn their triceps the same way she did: at the gym.

Copyright © 2013 USA TODAY, a division of Gannett Co. Inc.

The Food and Drug Administration will conduct fewer food safety inspections this year because of the government sequester, commissioner Margaret Hamburg said Wednesday in an exclusive interview with USA TODAY.

While consumers may not feel the impact immediately, the loss of $209 million from its budget will force the agency to conduct about 2,100 fewer inspections, an 18% decline compared to last year.

The funding loss, part of the $85 billion in automatic budget cuts that took effect March 1, will also delay the agency’s implementation of the 2011 Food Safety Modernization Act, Hamburg said in an interview with the USA TODAY Editorial Board.

The FDA could also take longer to review and approve new drugs, she said. “All of those programs will be compromised by the cuts,” she added. “Sequester is a big hit for us. … The cuts are real and will have impacts.”

The FDA will prioritize programs that have the greatest effect on public health, including disease outbreaks, she said. Hamburg does not expect to furlough workers.

One in six Americans, or 48 million people, develop a food-borne illness each year, according to the Centers for Disease Control and Prevention. About 3,000 die, and 128,000 are hospitalized.

The FDA is already facing sharp criticism, and even legal action, for being slow to implement the food safety law. The law aimed to refocus the FDA’s efforts on prevention, rather than responding to crises.

After being signed into law by President Obama in 2011, the law sat for two years with the White House Office of Management and Budget where it was rewritten in ways that weakened FDA’s oversight, says Food Safety News, an industry watchdog publication. A federal judge in California has ordered the FDA to work with two food-safety advocacy groups to create a new timetable to speed up the process.

“Nobody is more frustrated than we are” that the law isn’t yet in practice, said Michael Taylor, the FDA’s deputy commissioner for foods and veterinary medicine.

With every year that passes before the law is in practice, more people are at risk of getting sick, Taylor said.

Even before the sequester, the FDA was able to inspect less than 2% of all food imports, Taylor said.

Jean Halloran, director of food policy initiatives at Consumers Union, said she’s concerned that the cuts will lead to more outbreaks.

“That’s fairly alarming,” Halloran said. “It’s a huge step in the wrong direction.”

Others, such as Douglas Powell, a professor of food safety at Kansas State University, said private companies have no reason to slack off on food safety, with or without inspections.

Because companies are legally liable for the safety of their food, they have a strong economic incentive to inspect their own products and prevent outbreaks.

“The government is there to maintain a minimal standard, but they really inspect very little food,” Powell said. “It is in a company’s best interest to take that seriously and not make their customers barf.”

Hamburg also addressed other key issues:

• The FDA has made progress in fighting drug shortages, which have disrupted care for cancer patients and others. The number of shortages fell from 251 in 2011 to 121 in 2012, she said. In addition, the FDA prevented 280 drug shortages last year, by working with manufacturers and finding substitutes.

• Hamburg noted the difficulty of monitoring and overseeing compounding pharmacies, such as the one responsible for an outbreak of fungal meningitis last fall that killed 53 people and sickened more than 700. “We have a system that is broken,” she said. Hamburg said these pharmacies — many of which are now acting like manufacturers — are governed by a “patchwork of state laws.” A report released last week by Rep. Edward Markey (D-Mass.) found that no states require pharmacies to disclose the volume of compounded drugs they produce, or whether these drug were sold across state lines. Hamburg in the past has called on Congress to give the FDA explicit authority to regulate compounders.

• Hamburg said the FDA has not yet decided whether how to respond to a court’s recent ruling that emergency contraception, sold as Plan B, should be sold over the counter to anyone, regardless of age.

Contributing: Elizabeth Weise

Copyright © 2013 USA TODAY, a division of Gannett Co. Inc.

Leana Wen relives the Boston Marathon bombing every day.

After four years in the emergency room, Wen had seen her share of accidents, shootings, even amputations. But she says nothing in her eight years of medical training prepared her for that day.

“I am glad I was able to help,” says Wen, 30, a physician in her last year of a four-year residency at Massachusetts General Hospital. “I wish I could have helped more. But I wish I hadn’t seen it.”

Wen was nearing the end of her shift when a call came over the loud speaker, announcing that the hospital was about to get two patients injured in an explosion. As a top-level trauma center, treating two patients would be manageable, Wen thought. With some doctors arriving just as others were about to leave, the hospital had twice the usual number of physicians.

Minutes later, another call came in, explaining that there had been two explosions.

The ER was already completely full, Wen said. Dozens of other critically ill patients, including ones on respirators, had to be relocated to other parts of the hospital. Wen and other staff got everyone cleared in 30 minutes.

All too quickly, the ER was full again, with patients in more distress than Wen had ever seen. Some were silent; some asked repeatedly about family members. Others cried and screamed.

“At some point, I wanted to cry with them, but I couldn’t,” Wen said. “There was blood everywhere. On the floor, there were trails of it behind the stretchers.”

There was also soot from the explosions, and the smell of burned clothing, and burned flesh.

One of her most important jobs was triage: deciding which patients needed immediate treatment, which should be first in line for the operating room.

With so much blood everywhere, it wasn’t always easy to identify just where the bleeding was coming from. Once she located the source of bleeding, she worked to stop it, tying tourniquets on those in danger of bleeding to death. She performed CPR on patients without a pulse. She ordered blood and fluids to replace what patients had lost.

Wen had been working since 7 a.m. without a break before the bombing, and she didn’t get a break after. “I wasn’t weak,” she said, “because my adrenaline was so high.”

Even as she rushed to save lives, Wen’s attention was divided. She kept an eye on the scene around her, to make sure that there weren’t other patients who needed her more.

A phone in the ER beeps an alarm with every new patient. On Patriot’s Day, those alarms never seemed to stop.

Thirty-one of the more than 260 people injured that day were sent to Massachusetts General. Most seemed to arrive within the first 90 minutes, Wen said. At least four required amputation.

One of the most severely injured was Marc Fucarile. His left leg was fractured in several places. His right leg needed to be amputated. Burns covered half his body. Shrapnel was embedded everywhere, including his heart, said his fiancée, Jen Regan, on Monday.

Wen couldn’t help worrying about her own husband, who had gone to the finish line to see friends. Wen and her husband live just a block away from the site of the explosion at Copley Square.

“I was terrified that the next person I would be resuscitating would be my husband,” said Wen, who didn’t learn he was OK until two hours later.

“We kept hearing reports that there had been other explosions. We had no idea what was happening around us. We had no idea whether we would walk outside and see a war zone.”

The staff at Massachusetts General had been through emergency drills, and everyone knew what to do, Wen says. “We had people coming from all over the hospital asking, ‘How can I help?’ ”

But no one felt prepared for that day.

“I’ve never seen a shrapnel injury,” Wen said. “That’s just not something we see in an urban city in the U.S.

“It was very difficult to see so many people’s lives changed in one day. Seeing all those young people who were my age, who would have very different lives moving forward, if they had lives at all.”

But even after a 12-hour shift, she had no place to go home to. Because her apartment was so close to the crime scene, police had the area blocked off until late in the night.

More than a week later, Wen still has nightmares. Every new alarm beep takes her back to the day of the bombing, when it seemed like the number of patients coming through the doors would never end. Her neighborhood and all the places she usually goes — her bank, her grocery store — remain shuttered.

“I keep looking for lessons from this,” Wen said. “I don’t know what the lessons are.”

Copyright © 2013 USA TODAY, a division of Gannett Co. Inc.