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Entries in Ultrasounds (3)

Thursday
Apr192012

FDA Warns of Infection Risks from Contaminated Ultrasound Gel

Hemera/Thinkstock(WASHINGTON) -- The Food and Drug Administration is warning doctors, hospitals and clinics that contaminated ultrasound gel produced by a New Jersey company infected 16 cardiac patients and could pose serious risks to pregnant women and others who undergo ultrasound imaging and treatment.

The gel is used by radiologists, urologists, gastroenterologists, OB-GYNs, internists, nurses and ultrasound technicians for diagnostic ultrasound testing. Chiropractors and physical therapists use the gel for therapeutic ultrasound treatment of pain, inflammation and injuries.

The agency told the health professionals to stop using the gel because of contamination with two strains of bacteria. “Although Other-Sonic Generic Ultrasound Transmission Gel is not labeled as either sterile or non-sterile, it is NOT sterile,” the FDA cautioned.

The 16 heart patients became infected with the bacteria, Pseudomonas aeruginosa, while undergoing transesophageal ultrasound exams with Other-Sonic Generic Ultrasound Transmission Gel during heart valve replacement surgery at a single hospital, the FDA said. The product is made by Pharmaceutical Innovations Inc., of Newark, N.J., which bills itself on its website as a “world leader in medical ultrasound.”

In February, an FDA analysis of product samples revealed "significant amounts of Pseudomonas aeruginosa and Klebsiella oxytoca,” which the FDA said suggested that the contamination occurred “during the manufacturing process.”  Both types of bacteria can colonize the skin without causing any symptoms, although Pseudomonas also may cause skin eruptions, even on unbroken skin, the FDA warned. More concerning, however, is the potential of the bacteria to enter the body through ultrasound exams of the airway, lower digestive tract or a woman’s genital tract, where they could cause infection.

If you’re concerned about possible exposure to a contaminated gel, “the best thing to do is go home and take a good shower with soap and water,” or make sure the people performing your ultrasound “pat the area with alcohol afterwards,” said Dr. Robert A. Winters, an infectious disease specialist and chairman of the infection control division at Saint John’s Health Center in Santa Monica.

“Not every patient exposed to Pseudomonas aeruginosa and Klebsiella bacteria in Other-Sonic Generic Ultrasound Transmission Gel will develop colonization (the presence of bacteria at a site without any signs of infection) or infection, but the risk remains present,” the FDA alert said. It warned that biopsies can let bacteria get into tissues, causing an abscess or severe bloodstream infection called sepsis. If Klebsiella bacteria, which are common in the digestive tract, enter the lungs or spread to other tissues, they could lead to pneumonia, wound infection or bloodstream infections, the FDA said.

At the agency’s request, New Jersey health authorities embargoed all lots of the gel manufactured from June through December 2011. The U.S. Marshal Service has since seized those lots. Health professionals were urged to stop using 250 milliliter bottles and 5-liter dispensing containers with three lot numbers: 060111, 090111 and 120111. They were also asked to identify any patients who underwent ultrasound exams with gel from those lots.

“This ultrasound gel presented serious health risks to patients, particularly vulnerable ones,” Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs, said in a statement issued by the FDA. “Therefore, FDA, with the assistance of our state partner, is taking aggressive enforcement action to protect the public health.”

Copyright 2012 ABC News Radio

Wednesday
Apr112012

FDA Panel Approves Ultrasound Device for Spotting Hidden Breast Tumors

iStockphoto/Thinkstock(WASHINGTON) -- A U.S. Food and Drug Administration panel Wednesday approved the widespread use of an automated ultrasound machine that would give doctors a detailed image of dense breast tissue, helping them to spot cancerous tumors.

The FDA reviewed the safety and effectiveness of the Automated Breast Ultrasound, a device that uses an automated, Xerox-like system to get ultrasound images of breast tissue. ABUS is intended to screen women with dense breast tissue, for whom traditional mammograms may be inadequate.

"We know that mammography is limited by breast density," said Robert Smith, senior director of cancer screening at the American Cancer Society. "Sometimes the glandular tissue is so dense that radiation doesn't penetrate it. You can't see anything."

The dense tissue makes it easy for tumors to hide on traditional mammograms.

Some research estimates that about 40 percent of women have dense breast tissue.

According to ABUS' manufacturer, U-Systems, the device provides 3-D images of breast tissue and is intended for use along with mammograms, not in place of them, and to "increase breast cancer detection" in women with dense breasts who have already received a benign mammogram.

"This panel review, part of the FDA process for assessing new technology, brings us one step closer to an approved adjunctive screening tool for women with dense breasts," said Ron Ho, president and chief executive officer of U-Systems, in a statement.

Some say ultrasound is a valuable tool for finding breast tumors not easily spotted with other tests. Others say greater detection of abnormal spots on ultrasounds would lead to more biopsies but not necessarily better outcomes for women with breast cancer.

Mammograms are the gold standard of breast cancer screenings, and the U.S. Preventive Services Task Force recommends that women over age 50 get a mammogram once every two years to screen for breast cancer. Some groups, such as the American Cancer Society and the American College of Obstetrics and Gynecology, recommend that women begin getting mammograms at age 40.

For women at an increased risk of breast cancer, such as those with dense breasts or those who have had breast cancer before, doctors may use additional screening tools, such as MRIs or ultrasound, to check their breasts for problems.

Doctors currently use handheld ultrasound devices to hunt for breast tumors in some patients. But the practice is labor-intensive and depends on ultrasound technicians, who are often few and far between at hospitals around the country.

"One of the major drawbacks of handheld ultrasound is that it takes a lot of time," said Dr. Nagi Khouri, director of breast imaging at the Johns Hopkins Outpatient Center in Baltimore. "Whole breast ultrasound is highly desirable if it can be done with ease with few if any drawbacks."

Research has shown more screening does detect more breast cancer. A study published last week in the Journal of the American Medical Association found that annual mammograms combined with ultrasound and MRI significantly increased the detection of breast cancer in more than 2,600 women at higher risk of the disease. Mammograms alone detected cancer in 53 percent of the women, and ultrasound detected 33 additional cases. MRIs found nine cases that were not detected by mammogram or ultrasound.

But only 7.4 percent of those women ended up actually having breast cancer. The findings highlighted concerns that increased detection of breast abnormalities may lead to finding more cancer when there is none, called a false positive. High numbers of false positives could result in unnecessary biopsies and other medical procedures without an actual benefit for women's health.

"The fundamental problem is that we have no evidence that detecting these cancers by ultrasound actually saves lives," Dr. Daniel Kopans, a professor of radiology at Harvard Medical School, told ABC News last week. "With all the effort that has gone into ultrasound screening over the last decade, it is surprising that no one has done a randomized, controlled trial, which is the only way to know if finding these cancers actually saves lives."

Smith said more research on the use of ultrasound and other supplemental imaging is certainly needed, but researchers may find that the risk of finding something that turns out to be nothing may be worth it for some women.

"It may be that the combination of supplemental imaging has higher false positive rate, but I think we can accept a higher false-positive rate if a woman's risk is higher," he said. "Women have said pretty clearly, whatever the risk of a false positive is, they place a higher priority on finding breast cancer early."

Copyright 2012 ABC News Radio

Tuesday
Apr032012

Ultrasounds, MRIs Can Find More Breast Cancer, Says Study

iStockphoto/Thinkstock(PITTSBURGH) -- Here's one more study to add to the breast cancer screening debate: Annual mammogram screenings, combined with ultrasounds and MRIs, significantly increase the detection of cancer in women who had an elevated risk of breast cancer, new research has found.

Scientists at the University of Pittsburgh School of Medicine examined data from the American College of Radiology Imaging Network trial. Out of more than 2,600 women who were at increased risk of breast cancer (they had dense breast tissue and at least one other risk factor, such as a family history of the disease), 53 percent of the cancers were detected through mammograms. Ultrasounds picked up 33 additional cases of breast cancer, and MRIs found nine more that were not detected by either ultrasounds or mammograms.

"For women with dense breasts who are at higher risk, cancers tend to be more advanced," said Dr. Wendie Berg, the trial's principal investigator and professor of radiology at the University of Pittsburgh School of Medicine. "The combination of ultrasound and mammography is quite effective in finding the cancers."

The research was published Tuesday in the Journal of the American Medical Association and funded by the Avon Foundation and the National Cancer Institute.

While women with dense breast tissue may be at higher risk of developing breast cancer, the conundrum is compounded by the fact that mammograms are less likely to detect the cancer, so researchers said this is where supplemental screening tools can help.

Of note from the study, although more cancers were detected (adding ultrasound led to 242 patients undergoing biopsies), only 7.4 percent of these women ended up having cancer.

Federal guidelines currently suggest that women older than 50 receive a mammogram once every two years. But those guidelines clash with recommendations from the American College of Obstetrics and Gynecology, and the American Cancer Society. Both organizations recommend women begin getting annual mammograms at age 40.

The new research comes on the heels of a Norwegian study published Sunday in the Archives of Internal Medicine, which found that women who underwent regular mammogram screenings had an estimated 15 percent to 25 percent of breast cancers diagnosed, but raised the question as to whether the tumors might actually vanish without treatment.

Overdiagnosing and false-positives have long been part of the debate about breast cancer screenings, but Berg said most overdiagnosing occurs in women who have ductal carcinoma in situ, a cancer that hasn't spread past the milk ducts and is usually less severe than other forms of the disease.

"Oftentimes, DCIS will never come to matter in a woman's lifetime, but we didn't look at that," said Berg. "For these invasive cancers, it's hard to argue that they're not important because those are the ones more likely to spread and matter."

"The fundamental problem is that we have no evidence that detecting these cancers by ultrasound actually saves lives," said Dr. Daniel B. Kopans, a professor of radiology at Harvard Medical School. "With all the effort that has gone into ultrasound screening over the last decade, it is surprising that no one has done a randomized, controlled trial, which is the only way to know if finding these cancers actually saves lives."

Copyright 2012 ABC News Radio







ABC News Radio