July 30, 2013
Health fraud scams have been around for hundreds of years. The snake oil salesmen of old have morphed into the deceptive, high-tech marketers of today. They prey on people’s desires for easy solutions to difficult health problems—from losing weight to curing serious diseases like cancer.
According to the Food and Drug Administration (FDA), a health product is fraudulent if it is deceptively promoted as being effective against a disease or health condition but has not been scientifically proven safe and effective for that purpose.
Scammers promote their products through newspapers, magazines, TV infomercials and cyberspace. You can find health fraud scams in retail stores and on countless websites, in popup ads and spam, and on social media sites like Facebook and Twitter.
Not Worth the Risk
Health fraud scams can do more than waste your money. They can cause serious injury or even death, says Gary Coody, R.Ph., FDA’s national health fraud coordinator. “Using unproven treatments can delay getting a potentially life-saving diagnosis and medication that actually works. Also, fraudulent products sometimes contain hidden drug ingredients that can be harmful when unknowingly taken by consumers.”
Coody says fraudulent products often make claims related to:
July 21, 2013
Should I get breast implants? Are there alternatives? Will they need to be replaced?
And if you decide to get implants, there are even more questions. Saline or silicone? What style? How much monitoring is needed?
Researching breast implants can be overwhelming and confusing. The Food and Drug Administration (FDA) has online tools available to help women sort through the information and provides questions to consider before making the decision.
FDA has approved implants for increasing breast size in women, for reconstruction after breast cancer surgery or trauma, and to correct developmental defects. Implants are also approved to correct or improve the result of a previous surgery.
A number of studies have reported that a majority of breast augmentation and reconstruction patients are satisfied with the results of their surgery.
FDA has approved two types of breast implants for sale in the U.S.: saline (salt water solution)-filled and silicone gel-filled. Both have a silicone outer shell and vary in size, shell thickness and shape.
More Risks of Breast Implants
Silicone implants sold in the U.S. are made with medical-grade silicone. These implants undergo extensive testing to establish reasonable assurance of safety and effectiveness. Nonetheless, there are risks associated with all breast implants, including:
- additional surgeries
- capsular contracture—scar tissue that squeezes the implant
- breast pain
- rupture (tears or holes in the shell) with deflation of saline-filled implants
- silent (without symptoms) rupture of silicone gel-filled implants
FDA experts suggest five things women should know about breast implants.
1. Breast implants are not lifetime devices. The longer a woman has them, the greater the chances that she will develop complications, some of which will require more surgery. The patient can also request additional surgeries to modify the aesthetic outcome, such as size or shape.
“The life of these devices varies according to the individual,” says Gretchen Burns, a nurse consultant at FDA’s Center for Devices and Radiological Health (CDRH). “All women with implants will face additional surgeries—no one can tell them when.” While a few women have kept their original implants for 20-30 years, “that is not the common experience.”
2. Research products. Review the patient labeling. FDA advises that women look at the Summary of Safety and Effectiveness Data (SSED) for each implant to learn about their characteristics and the fillers used. SSEDs have been produced for all approved saline and silicone gel-filled breast implants. These summaries provide information on the indications for use, risks, warnings, precautions, and studies associated with FDA approval of the device. Look at the frequency of serious complications found in the SSED. The most serious are “those that lead to further surgeries, such as ruptures or capsular contracture,” says Tajanay Ki, a biomedical engineer in CDRH.
FDA advises health care providers to give women the full labeling—all of the patient information from the manufacturer—for an implant. Ask your surgeon for the most recent version of the labeling. You should have at least 1-2 weeks to review the information before making a decision, but with some reconstruction or revision surgery cases, it may be advisable to perform surgery sooner.
3. Communicate with the surgeon. Surgeons must evaluate the shape, size, surface texture and placement of the implant and the incision site for each woman. Ask the surgeon questions about his or her professional experience, the surgical procedure, and the ways the implant might affect an individual’s life.
Also, tell the surgeon about previous surgeries and your body’s response—for example, whether surgeries resulted in excessive scar tissue—and discuss your expectations. This helps the surgeon make operative decisions that achieve the desired appearance (i.e., incision location and size, implant size and placement). Many women undergo reoperation to change implant size. To achieve optimal results after the first procedure, careful planning and reasonable expectations are necessary.
4. Learn about long-term risks. Some women with breast implants have experienced connective tissue diseases, lactation difficulties or reproductive problems. However, current evidence does not support an association between breast implants and these conditions. FDA has identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin’s lymphoma. Women who have breast implants may have a very small but increased risk of developing ALCL in the fluid or scar tissue surrounding the implant. Like other lymphomas, ALCL is a cancer of the immune system and not of breast tissue.
5. Monitoring is crucial. FDA recommends that women with breast implants:
- promptly report any unusual signs or symptoms to their health care providers, and
- report any serious side effects to MedWatch, FDA’s safety information and adverse event reporting program.
Furthermore, women with silicone implants should get MRI screenings to detect silent ruptures three years after their surgery and every two years after that. Insurance may not cover these screenings.
Burns recommends that women with breast implants continue to perform self-examinations and get mammograms to look for early signs of cancer. “Just because you have implants doesn’t mean you can ignore other breast health recommendations,” she says.
July 10, 2013
Children are often prescribed codeine for pain relief after surgery to remove their tonsils or adenoids to treat chronic tonsillitis or sleep apnea, a condition in which breathing problems make it hard for them to sleep soundly.
However, some children have died after being given codeine in amounts that are within the recommended dose range.
In August 2012, FDA warned the public that this danger exists for children who are “ultra-rapid metabolizers” of codeine, meaning that their liver converts codeine to morphine in higher than normal amounts.
Since then, FDA has conducted a comprehensive safety review of codeine use in children. A search of FDA’s Adverse Event Reporting System (AERS) database from 1969 to May 1, 2012 identified 10 deaths and three overdoses associated with codeine. Many of these children were recovering from a surgery to remove their tonsils or adenoids.
A new boxed warning—FDA’s strongest warning—will be added to the drug label of codeine-containing products about the risk of codeine to manage pain in children after a tonsillectomy and/or adenoidectomy. (The drug label is the written material that accompanies a prescription medication.)
FDA strongly recommends against the use of codeine to manage pain in children after a tonsillectomy and/or adenoidectomy. The agency asks health care professionals to use an alternate pain reliever.
In addition, parents and caregivers need to be aware of the risks of codeine treatment after tonsillectomy or adenoidectomy and should ask for a different pain medicine if their child is prescribed codeine in that setting.
Why Not For Kids?
Codeine is an opioid pain reliever—a narcotic medication—used to treat mild to moderate pain. It is also used to reduce coughing, usually in combination with other medications. Codeine is available by prescription either alone or in combination with acetaminophen or aspirin, and in some cough and cold medications.
Codeine is converted to morphine in the liver by an enzyme. Some people have genetic variations that make this enzyme over-active, causing codeine to be converted to morphine faster and more completely than in other people. These ultra-rapid metabolizers are more likely to have higher than normal amounts of morphine in their blood after taking codeine. High levels of morphine can result in breathing difficulty, which may be fatal.
From one to seven in every 100 people are ultra-rapid metabolizers, but they are more common among some ethnic groups. Twenty-nine percent of North African and Ethiopian populations are ultra-rapid metabolizers, and about 6 percent of African American, Caucasian and Greek populations are also affected.
The only way to know if someone is an ultra-rapid metabolizer is to do a genetic test. There are FDA-cleared tests to check for ultra-rapid metabolism.
The cases occurred in children who showed evidence of being ultra-rapid metabolizers. The children ranged in age from 21 months to 9 years old. All of the children received doses of codeine that were within the typical dose range, meaning that they were not given extra amounts of the medication.
In these cases, the signs of morphine overdose developed within one to two days after the children started taking codeine.