Entries in Gel (4)


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


10 Tips to Keep Your Gel Manicure Safe

iStockphoto/Thinkstock(NEW YORK) -- Gel manicures are known for shining brighter and lasting longer than a regular manicure, lasting as long as two weeks without a crack.  But can the special process that gives your nails their patent leather gleam also be harmful to your health?

The gel manicure process requires four or five coats of polish, with each layer followed by a finish under a UV light -- a similar light to those used in tanning beds, only far weaker.

Some dermatologists warn the typical five- to 10-minute exposure to the light during a gel manicure could be harmful.  A 2009 article in the Archives of Dermatology concluded that “further investigation” was warranted to see if the UV nail lamps can cause cancer.

A nail-industry sponsored study conducted at the Lighting Sciences Inc., an independent lab in Scottsdale, Ariz., found that getting a gel manicure every two weeks is equivalent to spending an extra two minutes in the sun every day.

Just as dermatologists have long advocated wearing sunscreen on a daily basis, they now also recommend wearing sunscreen on your hands when you go for a gel manicure.

Nail drying lights emit UV-A rays and not all sunscreens protect against those.  That’s why dermatologists say you should be sure to apply a “broad spectrum” sunscreen that protects against both UV-A and UV-B rays before any manicure.

The American Academy of Dermatology (AAD) says sunscreens with the following ingredients provide broad spectrum protection: Avobenzone, cinoxate, ecamsule, menthyl anthranilate, octyl methoxycinnamate, octyl salicylate, oxybenzone, sulisobenzone, zinc oxide and titanium dioxide.

Here are 10 warning signs to look for when getting a gel manicure -- or any manicure -- according to the Professional Beauty Association:

1. Your salon uses bottles in unmarked containers.
2. The products smell unusually strong or have a strange odor.
3. Your skin is abraded or cut during the procedure.
4. The instruments used on you are not sterilized.
5. Your skin or nails hurt during or after the nail service.
6. The technician cannot tell you what is in the products.
7. The salon is not clean.
8. Licenses for the salon and individual operators are not visibly posted
9. You see swelling, redness or other signs of infection around your nails.
10. You are not asked to wash your hand and you do not see the nail technician wash his/her own hands before the nail service.

Copyright 2012 ABC News Radio


FDA Approves Gel to Help Treat Fecal Incontinence

Jupiterimages/Thinkstock(SILVER SPRING, Md.) -- The U.S. Food and Drug Administration approved an injectable gel last Friday that can be used towards treating fecal incontinence in patients who have not seen results with other therapies or medications.

The gel, called Solesta and produced by Oceana Therapeutics Inc. in Edison, New Jersey, works by being injected into the tissue layer beneath the lining of the anus.  Once applied, it helps tissue grow in that area, narrowing the opening of the anus and, therefore, helping patients gain better bowel control.

The FDA approved the gel after conducting a clinical study of over 200 patients.  The administration found that after six months, more than half of the patients who were treated with Solesta saw a 50 percent decrease in the number of times they experienced fecal incontinence.

Although a third of the patients who weren't treated with the gel also experienced a similar reduction, the FDA reasoned that "a greater proportion of patients treated with Solesta experienced improvements, indicating the gel provides benefit."

Copyright 2011 ABC News Radio


Progesterone Gel Reduces Rate of Premature Birth By 45 Percent

Photodisc/Thinkstock(WASHINGTON) -- The medical community was sent into an uproar recently when KV Pharmaceuticals jacked up the price of 17P, one of the only drugs currently approved to treat preterm birth.  But hope for a new, affordable alternative treatment for certain women at risk of preterm delivery may be on the horizon thanks to new research from the National Institutes of Health.

Unlike 17P, which delivers synthetic progesterone by injection, the drug in question is a naturally-derived progesterone gel applied vaginally.  According to results published Wednesday by the NIH, the gel reduced the rate of preterm birth by 45 percent in women identified as having a short cervix, one of many risk factors for premature delivery.

One of the hardest parts of predicting and treating preterm birth is that early delivery can occur for a number of reasons, and each may require different treatment approaches, says lead author on the study, Dr. Roberto Romero, program head for Perinatology Research and Obstetrics and chief of the Perinatology Research Branch.

One risk factor is having had a preemie baby already -- the risk factor that makes a woman eligible for 17P.  The problem is, about 60 percent of preterm babies come from a mother who does not have a history of preterm birth, so "the question becomes, how else can we assess risk?" says Romero.

This is where testing for a short cervix comes in.  Using a simple ultrasound, doctors can screen for a short cervix during pregnancy and identify a woman as at risk for preterm birth.  By daily applying the gel, which currently costs between $10 and $15 and is prescribed during in vitro fertilization, the rate of these preterm births before the 33rd week of pregnancy can be nearly cut in half.

Though this will only address a small portion of all the preterm births, Romero says that this study argues for universal screening of cervix length to prevent what he estimates will be thousands of premature births annually in the U.S. 

Copyright 2011 ABC News Radio

ABC News Radio