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Hip Resurfacing - Birmingham Hip Resurfacing (BHR) System

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What is it? The Birmingham Hip Resurfacing (BHR) System is a metal on metal resurfacing artificial hip replacement system, surgically implanted to replace a hip joint. The BHR is called a resurfacing prosthesis because only the surface of the femoral head (ball) is removed to implant the femoral head resurfacing component.

How does it work? The BHR System has two parts: a socket in the shape of a shallow cup (acetabular component), and a cap in the form of a ball head (femoral resurfacing component).

* The cup replaces the damaged surface of your hip socket (acetabulum).
* The cap covers the ball-shaped bone at the top of your thigh (femoral head), and the cap has a small stem that is inserted into the top of your thighbone.

The cap moves within the cup. The surfaces that rub against each other (the bearing couple) are made from highly-polished metal. This type of bearing couple is called a metal-on-metal bearing couple.

When is it used? The BHR System relieves hip pain and improves hip function by replacing the parts of your hip that have been severely damaged by degenerative joint diseases. Degenerative joint diseases include osteoarthritis, rheumatoid arthritis, traumatic arthritis, dysplasia, or avascular necrosis.

The BHR System is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip replacement due to an increased possibility of requiring future hip joint revision.

What will it accomplish? The BHR System relieves pain and improves hip function.

When should it not be used? The BHR System should not be used in a patient who:

* Has an infection of the body or blood.
* Has bones that are not yet fully grown.
* Has any blood vessel-related disease, muscle-related disease, or nerve-and-muscle-related disease that will prevent the artificial hip joint system from remaining stable, or that may prevent following instructions during the recovery period.
* Has bones that are not strong enough or healthy enough due to:
o severe bone loss (osteoporosis) or a family history of severe bone loss;
o bone loss, such as avascular necrosis, affecting more than half of the femoral head; or
o multiple fluid-filled cavities (cysts) greater than 1 centimeter in the femoral head.
o A test, such as DEXA scan, may be needed to determine the level of bone loss.
* Is female and of child-bearing age. It is unknown whether metal ions released by the device could harm an unborn child.
* Has a kidney with significantly impaired function. The patient will need testing (creatinine, GFR, BUN) before and/or after surgery to test the kidneys.
* Has had reactions to wearing metal jewelry (metal sensitivity).
* Has a suppressed immune system due to diseases such as AIDS, or is receiving high doses of corticosteroids.
* Is severely overweight.

Your doctor will need complete information about your overall health to determine whether the BHR system is right for you. You should tell your doctor about any health problems, even if they are not related to the hip, because some medicines and diseases (such as diabetes) can affect kidney or bone strength.

New Vaccine Prevents Cervical Cancer

The Food and Drug Administration has approved Gardasil, the first vaccine developed to prevent cervical cancer and precancerous genital lesions and genital warts due to certain types of human papillomavirus (HPV). The vaccine is approved for use in females ages 9 years to 26 years. Gardasil was evaluated and approved in six months under the FDA's priority review process--a process for products with potential to provide significant health benefits.

HPV is the most common sexually transmitted infection in the United States. The Centers for Disease Control and Prevention estimates that more than 6 million Americans become infected with genital HPV each year and that more than half of all sexually active men and women become infected at some time during their lifetimes. On average, there are 9,710 new cases of cervical cancer and 3,700 deaths attributed to it in the United States each year. Worldwide, cervical cancer is the second most common cancer in women and is estimated to cause over 470,000 new cases and 233,000 deaths each year.

For most women, the body's own defense system will clear the virus, and infected women do not develop related health problems. Some HPV types, however, can cause abnormal cells on the lining of the cervix that can turn into cancer years later. Other HPV types can cause genital warts. The vaccine is effective against HPV types 16 and 18, which cause about 70 percent of cervical cancers, and against HPV types 6 and 11, responsible for about 90 percent of genital warts.

--This vaccine is a significant advance in the protection of women's health in that it strikes at the infections that are the root cause of many cervical cancers," says Acting FDA Commissioner Andrew C. von Eschenbach, M.D. "The development of this vaccine is a product of extraordinary work by scientists as well as by FDA's review teams to help facilitate the development of very novel vaccines to address unmet medical needs."

Gardasil is given as three injections over a six-month period. Immunization is expected to prevent most cases of cervical cancer due to HPV types included in the vaccine. Females, however, are not protected if they have been infected with the HPV types prior to vaccination. Also, Gardasil does not protect against less common HPV types not included in the vaccine; therefore, regular Pap screening remains critically important to detect precancerous changes in the cervix to allow treatment before cervical cancer develops.

Four studies, one in the United States and three multinational, were conducted in 21,000 women to examine how well Gardasil worked in women ages 16 to 26 by giving them either the vaccine or an inactive injection (placebo). In women who had not already been infected, Gardasil was nearly 100 percent effective in preventing precancerous cervical lesions, precancerous vaginal and vulvar lesions, and genital warts caused by infection with the HPV types against which the vaccine is directed. While the study period was not long enough for cervical cancer to develop, the prevention of these cervical precancerous lesions is believed highly likely to result in the prevention of those cancers.

The studies also evaluated whether the vaccine can protect women already infected with some HPV types included in the vaccine from developing diseases related to those viruses. The results show that the vaccine is only effective when given prior to infection.

Two studies were also performed to measure the immune response to the vaccine among younger females ages 9 years to 15 years. Their immune response was as good as that found in 16 to 26 year olds, indicating that the vaccine should have similar effectiveness when used in younger females.

The safety of the vaccine was evaluated in about 11,000 individuals. Most adverse experiences in study participants who received Gardasil included mild or moderate local reactions, such as pain or tenderness at the site of injection.

The manufacturer Merck & Co. Inc. of Whitehouse Station, N.J., has agreed to conduct additional studies to further evaluate general safety and long-term effectiveness. Merck also will monitor the pregnancy outcomes of women who receive Gardasil while unknowingly pregnant. Also, the manufacturer has an ongoing study to evaluate the safety and effectiveness of Gardasil in males.

 
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