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San Diego, California News Station – KFMB Channel 8 – cbs8.comFDA panel sees little use for metal-on-metal hips

By MATTHEW PERRONEAP Health Writer

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.”

Copyright 2012 the Associated Press. all rights reserved. this material may not be published, broadcast, rewritten or redistributed.

San Diego, California News Station – KFMB Channel 8 – cbs8.comFDA panel sees little use for metal-on-metal hips

FDA Steps Up Scrutiny of Metal Hip Implants

The U.S. Food and Drug Administration responded to mounting concerns about the safety of metal-on-metal hip implants, saying it would subject the devices to a two-day expert review that could lead to rigorous new standards.

The FDA announced on Thursday an advisory panel for June 27-28 that will gather input from scientists, researchers, patients and medical practitioners to help regulators decide whether to impose new testing standards and review requirements to be met before a device can be sold in the United States.

“We are asking outside scientific and medical experts to discuss recent information on these devices so that the agency can continue to make reliable safety recommendations,” Dr. William Maisel, deputy director of science at FDA’s Center for Devices and Radiological Health, said in a statement.

Shares in orthopedic device manufacturers were lower after the announcement, with Stryker Corp down 0.7 percent, Zimmer Holdings inc down 1.1 percent and Johnson & Johnson off 0.3 percent.

Hip replacement surgery is a common, costly procedure intended to provide greater mobility and alleviate pain for people with joint problems, including arthritis.

About 270,000 hip replacements are performed each year in the United States, accounting for nearly 40 percent of all joint replacements, according to the British Medical Journal. Analysts say the procedure can cost upwards of $17,000.

But evidence has been growing for years that all-metal hip implants fail at higher rates than systems that use other materials. Patients who receive them have also been shown to have high concentrations of metal ions in their blood.

A recent study from the National Joint Registry of England and Wales showed that about 6 percent of people with the metal-on-metal variety needed additional surgery to replace or repair them after five years, compared with 1.7 to 2.3 percent of people who had ceramic or plastic systems.

The FDA’s announcement on Thursday followed a May 2011 order from the agency requiring manufacturers of metal-on-metal implants to collect more safety data on the devices.

Manufacturers have been plagued by recalls. In January, J&J announced it would take a $3 billion charge to cover the cost of recalling metal hips produced by its DePuy Orthopedics unit.

The FDA said the upcoming advisory panel meeting would look at failure rates, metal ion testing, imaging methods, patient risk factors, follow-up surgery and complications associated with metal-on-metal hip replacement and resurfacing systems.

FDA Steps Up Scrutiny of Metal Hip Implants

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FDA OKs 3rd Silicone-Gel Breast Implant – MedicineNet

By Steven Reinberg and Lisa EspositoHealthDay Reporters Latest Womens Health News

FRIDAY, March 9 (HealthDay News) — a new silicone-gel breast implant received conditional approval Friday from the U.S. Food and Drug Administration. The implant can be used for breast augmentation in women 22 and older and for breast tissue reconstruction at any age.

The newest implant, manufactured by Sientra of Santa Barbara, Calif., becomes the third approved for use in the United States, joining devices made by Allergan and Mentor. As a condition for approval, Sientra will continue studies on the implant’s long-term safety, effectiveness and risks of rare diseases, the FDA noted.

“Data on these and other approved silicone-gel filled breast implants continue to demonstrate a reasonable assurance of safety and effectiveness,” Dr. William Maisel, deputy director for science in the FDA’s Center for Devices and Radiological Health, said in an agency news release.

Silicone breast implants have been controversial for years, with critics contending that the devices can rupture and leak silicone, potentially causing a variety of health problems, including cancer and lupus.

Classified as medical devices, silicone implants are surgically placed under breast tissue or chest muscle to reconstruct or augment the breast.

In reconstruction, the implant usually replaces breast tissue removed because of cancer or trauma or breast tissue affected by a severe breast abnormality. another reason is to revise or improve results from a previous reconstruction surgery, according to the FDA.

Similarly, breast augmentation is used to increase breast size or to improve on previous augmentation surgery.

The FDA approval of Sientra’s implant is based on three years of data from clinical studies on nearly 1,800 patients. Complications included tightening of the area around the implant, re-operation, implant removal, uneven appearance and infection, according to the agency’s release.

The company’s additional long-term studies will include a seven-year follow-up of the current participants; a 10-year study of nearly 5,000 women to monitor long-term complications, including rheumatoid arthritis, breast and lung cancer; and five studies focusing on possible links between the new implant and connective tissue and neurological diseases, brain cancer, cervical/valvular cancer and lymphoma, the FDA said.

Reaction to the latest approval came swiftly.

Dr. John Oeltjen, an assistant professor of plastic surgery at the University of Miami School of Medicine, thinks the FDA decision is a good one.

“The implant from Sientra is like the implants from other companies already marketing implants,” he said. “So that’s not out of line.”

“In general, there are no problems with silicon gel implants,” he said. The advantage of silicon gel over saline implants is that the silicon has a more natural look and feel, he added, while saline implants can wrinkle, which can show through the skin.

However, Oeltjen said he would like to see the FDA also allow marketing of contoured implants, which are not round, but shaped more like a natural breast.

Dr. Jeffrey C. Salomon, a clinical professor of plastic surgery at Yale University School of Medicine, noted, “Sientra is a brand that has been used in Brazil for an extended length of time, and I doubt that there were concerns about cancer, otherwise the FDA would have not approved them.”

He added, “While the next generation of breast implants is the so-called form stable variety, those implants have not been released in the U.S. despite being used throughout the world for a few years.”

“The form stable implant does not develop capsular contracture, which is a response by the body to a foreign object and can result in pain and discomfort as the implant is squeezed by fibers created by the immune system,” he added. “And that is really the category of breast implant surgeons are anticipating the release of.”

Silicone gel implants had been banned in the United States for 14 years, until 2006 when the FDA approved the ones made by Allergan and Mentor for breast reconstructive surgery and for breast enlargement in women 22 and older.

But, when the ban was lifted, the FDA noted that there wasn’t a lot of data on adverse effects, including what the agency called “rare events” and “long-term performance.” In light of this, the agency required the manufacturers to do studies on the implants’ safety and performance after their approval.

Then last September, after a contentious two-day hearing, the FDA ruled that silicone implants were safe and could remain on the market. however, the agency said at the time that it would work with manufacturers of the devices approved for use in the United States to improve studies gauging the health of women who received the implants.

The FDA emphasized last year that silicone implants don’t last forever, with as many as half of women with such implants requiring removal within 10 years of the initial surgery. According to the agency, one in five women who receives silicone implants to increase the size of her breasts will need to have the devices removed within 10 years due to complications. And as many as half of women who receive implants for reconstruction after breast surgery will need them removed within the same time frame.

Common complications include: hardening of the area around the implant; the need for additional surgeries; and implant removal. Other frequent problems include implant rupture, wrinkling, breast asymmetry, scarring, pain and infection, the FDA said.

The FDA recommends that women who get silicone implants: follow-up regularly with their doctor, which includes occasional MRIs to detect potential ruptures; pay attention to any changes and notify their health-care provider if they notice any unusual symptoms such as pain, asymmetry or swelling; and educate themselves on the signs and symptoms of complications.

“It’s important to remember that breast implants are not lifetime devices,” Maisel said. “Women should fully understand risks associated with breast implants before considering augmentation or reconstruction surgery, and recognize that long-term monitoring is essential.”

According to FDA estimates, 5 million to 10 million women worldwide have breast implants.

MedicalNewsCopyright © 2012 HealthDay. All rights reserved.

SOURCES: March 9, 2012, news release, U.S. Food and Drug Administration; John Oeltjen, M.D., assistant professor of plastic surgery, University of Miami School of Medicine; Jeffrey C. Salomon, M.D. clinical professor of plastic surgery, Yale University School of Medicine, New Haven, Conn.

FDA OKs 3rd Silicone-Gel Breast Implant – MedicineNet