WASHINGTON (AP) – Government health experts said Thursday there are few reasons to continue using metal-on-metal hip implants, amid growing evidence that the devices can break down early and expose patients to dangerous metallic particles.
The Food and Drug Administration asked its 18-member panel to recommend guidelines for monitoring more than a half-million U.S. patients with metal hip replacements. The devices were originally marketed as a longer-lasting alternative to older ceramic and plastic models. But recent data from the U.K. and other foreign countries suggests they are more likely to deteriorate, exposing patients to higher levels of cobalt, chromium and other metals.
While the FDA has not raised the possibility of removing the devices from the market, most panelists said there were few, if any, cases where they would recommend implanting the devices.
“I do not use metal-on-metal hips, and I can see no reason to do so,” said Dr. William Rohr of Mendocino Coast District Hospital, who chaired the meeting.
For decades nearly all orthopedic implants were coated with plastic or ceramic. But in the last 10 years some surgeons began to favor all-metal implants, after laboratory tests suggested the devices would be more resistant to wear and reduce the chances of dislocation.
But recent data gathered from foreign registries shows the devices fail at a higher rate than older implants. That information comes on top of nearly 17,000 reports to the FDA of problems with the implants, which sometimes require invasive surgery to replace them.
The pain and inflammation reported by patients is usually caused by tiny metal particles that seep into the joint, damaging the surrounding tissue and bone. The long-term effects of elevated metal levels in the bloodstream are not clear, though some studies have suggested links to neurological and heart problems.
About 400,000 Americans get a hip replacement each year to relieve pain and restore motion affected by arthritis or injury. Metal hips accounted for about 27 percent of all hip implants in 2010, down from nearly 40 percent in 2008. Doctors have begun turning away from the implants amid several high-profile recalls, including J&J's recall of 93,000 metal hips in 2010.
FDA's experts said Thursday that patients complaining of pain and other symptoms should get regular X-rays and blood testing for metal levels. however, panelists pointed out the problems with the accuracy of blood tests and the difficulties of interpreting the results. there are no standard diagnostic kits for sale that test for chromium and other metals
For patients who are not experiencing pain, panelists said annual X-rays would be sufficient to monitor their implants.
If the FDA ultimately follows the group's advice, U.S. recommendations would be less involved than those already in place overseas.
Earlier this year U.K. regulators recommend that all people who have the implants get yearly blood tests to make sure no dangerous metals are seeping into their bodies.
FDA regulators have suggested they want to take more time to sort out the differences between various implants and patient groups before making recommendations.
“The truth is there are different types of hips and different types of patients,” said Dr. William Maisel, FDA's chief scientist for devices, in an interview last week. “Understanding the characteristics of patients who experience adverse events is very important.”
Women and overweight people are among the groups that are more likely to have an implant failure.
With little definitive data on U.S. hip implants, the agency has asked manufacturers like Johnson & Johnson, Zimmer Holdings inc. and Biomet inc. to conduct long-term, follow-up studies of more than 100 metal-on-metal hips on the U.S. market.
FDA scientists say the studies will help “fill in the blanks” on a number of scientific questions, including the long-term effects of metal particles.
But public health advocates say it could take a decade before that information is available.
“Keeping these metal-on-metal hips on the market for the next five to 10 years while research is conducted is not ethical,” said Diana Zuckerman, president of the National Research Center for Women & Families, during a public comment session at the meeting. “If the companies want to sell metal-on-metal hips, they should be required to prove their safety first.”
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WASHINGTON (AP) — Government health experts said Thursday there are few reasons to continue using metal-on-metal hip implants, amid growing evidence that the devices can break down early and expose patients to dangerous metallic particles.
The Food and Drug Administration asked its 18-member panel to recommend guidelines for monitoring more than a half-million U.S. patients with metal hip replacements. The devices were originally marketed as a longer-lasting alternative to older ceramic and plastic models. but recent data from the U.K. and other foreign countries suggests they are more likely to deteriorate, exposing patients to higher levels of cobalt, chromium and other metals.
While the FDA has not raised the possibility of removing the devices from the market, most panelists said there were few, if any, cases where they would recommend implanting the devices.
“I do not use metal-on-metal hips, and I can see no reason to do so,” said Dr. William Rohr of Mendocino Coast District Hospital, who chaired the meeting.
For decades nearly all orthopedic implants were coated with plastic or ceramic. but in the last 10 years some surgeons began to favor all-metal implants, after laboratory tests suggested the devices would be more resistant to wear and reduce the chances of dislocation.
But recent data gathered from foreign registries shows the devices fail at a higher rate than older implants. that information comes on top of nearly 17,000 reports to the FDA of problems with the implants, which sometimes require invasive surgery to replace them.
The pain and inflammation reported by patients is usually caused by tiny metal particles that seep into the joint, damaging the surrounding tissue and bone. The long-term effects of elevated metal levels in the bloodstream are not clear, though some studies have suggested links to neurological and heart problems.
About 400,000 Americans get a hip replacement each year to relieve pain and restore motion affected by arthritis or injury. Metal hips accounted for about 27 percent of all hip implants in 2010, down from nearly 40 percent in 2008. Doctors have begun turning away from the implants amid several high-profile recalls, including J&J’s recall of 93,000 metal hips in 2010.
FDA’s experts said Thursday that patients complaining of pain and other symptoms should get regular X-rays and blood testing for metal levels. however, panelists pointed out the problems with the accuracy of blood tests and the difficulties of interpreting the results. There are no standard diagnostic kits for sale that test for chromium and other metals
For patients who are not experiencing pain, panelists said annual X-rays would be sufficient to monitor their implants.
If the FDA ultimately follows the group’s advice, U.S. recommendations would be less involved than those already in place overseas.
Earlier this year U.K. regulators recommend that all people who have the implants get yearly blood tests to make sure no dangerous metals are seeping into their bodies.
FDA regulators have suggested they want to take more time to sort out the differences between various implants and patient groups before making recommendations.
“The truth is there are different types of hips and different types of patients,” said Dr. William Maisel, FDA’s chief scientist for devices, in an interview last week. “Understanding the characteristics of patients who experience adverse events is very important.”
Women and overweight people are among the groups that are more likely to have an implant failure.
With little definitive data on U.S. hip implants, the agency has asked manufacturers like Johnson & Johnson, Zimmer Holdings Inc. and Biomet Inc. to conduct long-term, follow-up studies of more than 100 metal-on-metal hips on the U.S. market.
FDA scientists say the studies will help “fill in the blanks” on a number of scientific questions, including the long-term effects of metal particles.
But public health advocates say it could take a decade before that information is available.
“Keeping these metal-on-metal hips on the market for the next five to 10 years while research is conducted is not ethical,” said Diana Zuckerman, president of the National Research Center for Women & Families, during a public comment session at the meeting. “If the companies want to sell metal-on-metal hips, they should be required to prove their safety first.”
According to many health experts, belly fat is the biggest complaint women have about their bodies. As a result, interest in finding ways to lose that belly fat when exercise and diet programs have failed them motovates many women to consider non-surgical reduction procedures toward achieving a slimmer and more flattering waistline.
Televised health shows and news segments have picked up on this interest and subsequently aired brief info-pieces that barely go skin deep in explaining how belly fat reduction procedures work and what women really need to know before deciding on a procedure.
The following is a list of 3 popular belly fat reduction procedures and what some experts have to say about the procedures and their results.
Belly Fat Reduction Procedure #1: Thermage
According to will Richardson, MD a dermatology specialist who owns Natura Dermatology & Cosmetics, Thermage is a cosmetic procedure that uses radiofrequency energy to create heat energy in the dermis of the skin to create a focal area of thermal injury. the thermal energy causes immediate collagen contraction in the skin that results in a tighter surface profile. In addition, Thermage also causes collagen remodeling via the skin’s fibroblast cells.
Dr. Michael Escobedo of the Escobedo Esthetics Body Sculpting & Skin Center concurs with Dr. Richardson and states that he “…has used Thermage laser for many years and that Thermage does nothing for shrinking fat cells or improving the appearance of cellulite,” but rather, that it is used to create more collagen and tighten the skin.
Online descriptions of the procedure note that the patient generally has to be prepped with pain medication before treatment begins because of pain and soreness associated with the intensity of the radiofrequency energy used. In some reviews by patients who have used Thermage, one of their primary complaints is the amount of pain they experienced. One woman described it as being like having lit cigarette butts put out on her skin while the Thermage device was applied.
Mauro Romita, MD, P.C.—a specialist in Aesthetic and Reconstructive Plastic Surgery with skinMDny™ —says that the use of Thermage and other related radiofrequency therapies is problematical because there are a lot of questions in the industry over just how much effective radiofrequency energy can be applied to the dermis without burning it and causing thermal injury below the skin.
“Data shows that you need to get around 40 degrees centigrade (104 degrees F) to create any sort of collagen denaturing, and at 42 degrees centigrade (108 degrees F) you get a thermal burn…and you can rarely heat skin up to 40 degrees without creating damage to the surface,” says Dr. Romita.
With respect to the effectiveness of Thermage, patient reviews are mixed. While some patients claim that they did see a positive result months following the treatment and were satisfied, others stated that the results were not what they expected and felt that they had paid too much for what they got.
“The effects of Thermage are very subtle. every time I’ve seen them presented at a plastic surgery meeting it’s very hard to tell the ‘before’ from the ‘after’,” says Dr. Romita. Dr. Romita explains that from a cost effectiveness standpoint, that Thermage is not a choice he would recommend.
Thermage ranges from $2000 to $5000 depending on the facility that provides the service. One patient review expressed dissatisfaction with a lower-priced service, but found it worthwhile after a second treatment at a higher-priced facility.
Belly Fat Reduction Procedure #2: VelaShape
The mechanism behind the VelaShape procedure as explained by Dr. Richardson is a three pronged attack against belly fat using a combination of mechanical suction, radiofrequency (RF) and infrared (IR) energies that reportedly cause the fat cells to become smaller by stimulating an increase in their metabolism rate.
The procedure is described as an athletic or “deep tissue” massage where the patient will feel some pulling on the skin as the clinician maneuvers a pulsed vacuum device over the skin. the patient will also experience a warming sensation as the heat from the RF and IR energies work on the fat cells beneath the skin’s surface—but should be relatively painless.
“If VelaShape gives any effect at all on cellulite, it’s because of the vacuum massage capabilities,” says Dr. Romita. He explains that the real benefit from the vacuum massage is it physically stretches the tissues below the skin and as a result stimulates new collagen production to repair the stretched collagen. In addition he states that the massage also increases circulation and causes a decrease in the volume of the fat cells by increasing lymphatic drainage. “The mechanical deep tissue massage of these machines…that’s where the effects come from,” he says.
When asked about the effectiveness of the IR energy Dr. Romita said, “I don’t think that there is any data showing any meaningful effects by the infrared energy on the fat cells.”
Patient reviews of the VelaShape procedure reveal for the most part that either the patient totally loves it or hates it—not much between. Apparently for those who were dissatisfied with the procedure it did nothing for them. For those who were favorable toward their reviews, the primary benefit for belly fat was that it significantly reduced the cellulite appearance and gave their belly skin a flatter, smoother look.
Belly Fat Reduction Procedure #3: LipoSonix
LipoSonix is a relatively new procedure that Dr. Richardson says is currently a hot area of study due to the ability to focus high intensity ultrasound energy at specific levels in the tissues. He says that the procedure is proven by multiple studies that demonstrate that the ultrasound energy damages and destroys the fat, which is then eaten up by macrophages from the immune system in response to the treatment. He suggests, however, that a related procedure called “CoolSculpting” uses the same principles with cooling techniques that results in a more comfortable experience and no need for anesthesia.
The chief benefit advertised online and on TV is that LipoSonix destroys excess fat at depths of an inch or more without doing any damage to the skin’s upper layer and that one treatment for one hour can reduce your circumference around your belly up to one inch or more.
Dr. Romita states that the procedure can work in removing some fat from the body, but that it is also a painful and expensive process. He believes that over time that this technology and ones using cooling techniques to freeze the fat cells will eventually show effectiveness.
“But what you need to remember when you use these techniques that destroys the fat cells, that there’s one problem that no one cares to address, and that is—what happens to the fat?” Dr. Romita cautions.
Dr. Romita expands on this by pointing out that when you destroy fat cells, you are breaking fat cells down into their components that have to go somewhere in the body and be metabolized. Some of the more worrisome components are environmental toxins and radicals that reside in fat cells. therefore, when someone is having a LipoSonix treatment and a significant amount of fat cells are being destroyed, the concern then is whether this places the patient at risk of suffering from a metabolic toxicity problem from all the toxins released at high levels in the circulation following the treatment.
“They’ve done research in Korea where they have found some metabolic toxicity associated with these treatments— that’s why liposuction is so safe, because it sucks everything out,” says Dr. Romita.
Dr. Romita says that if you want to lose a little weight overall and are willing to spend thousands of dollars for these types of non-invasive treatments, that they may work for some people, but when it comes to significant fat reduction around the abdomen, on the hips, etc., that liposuction is recommended and is very safe.
Patient reviews of the LipoSonix procedure were overwhelmingly positive. almost all patients who had had LipoSonix reported that they did see a marked improvement in belly fat reduction and were pleased with the results. Another point that they all seemed to be in agreement on was the need for pain meds to deal with the pain during the procedure. Interestingly, when a popular health TV show performed a live LipoSonix treatment onstage, there was no mention made of the patient being prepped with pain medication; and, when asked how the treatment felt, the participant smiled and said “Only a little tingling.”
“Only a little tingling,” is one of the take-home points to having experts weigh-in with their opinions on non-surgical, cutting-edge belly fat reduction procedures as discussed above. too often, advertisements of the procedures focus on the promise of what a patient might look like afterward, but not what they will have to go through both physically and economically. furthermore, many websites promoting non-surgical cosmetic procedures state that they are “FDA Approved,” which is a stretch (or intentional lie) from the true FDA designation of being “FDA Cleared.”
“There’s a big difference between FDA approval of a prescription medication and something “cleared” by the FDA,” says Dr. Romita.
Dr. Richardson concurs with Dr. Romita and explains that the difference between the two designations is this: the actual terminology published in numerous advertisements is not used correctly when the consumer takes the time to review the facts. FDA-approved means that the medical device has been researched and found to be safe and effective in the current form. FDA-cleared, rather, only implies that a medical device has been allowed to come to market to the consumer because the company identified medical devices that were previously shown to be safe and effective, not the actual device in the advertisement itself.
In summary, non-surgical, cutting-edge belly fat reduction procedures can work for some patients, but the consensus is that when they do, that the results are minimal and are costly and in some cases painful. Recommendations by experts is that if you want to lose a few pounds then your best bet is to get a nutritionist to help you with a meal plan, take up exercising and give yourself time to get results. However, when faced with problem areas that just won’t go away no matter what you do, then it’s time do your research, learn as much as you can about the options available, and although liposuction is an old method that is invasive—it is proven safer and more effective over the latest non-surgical belly fat reducing procedures advertised today.
By MATTHEW PERRONEAP Health Writer
