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Archive for February, 2012

Metal on Metal (MoM) Hip Replacements: Risks, Replacements and Revisions

Posted on February 20th, 2012 by Robert D. Rowland

For years, the material of choice for total hip arthroplasty was polyethylene-lined acetabular cups, mated with ceramic or metal femoral heads. But over time, the polyethylene liner would wear out – even more quickly for more active people – requiring replacement surgery. Ceramic hip components, also a popular choice for years, could chip or break from use.

These materials led the way for the metal-on-metal (MoM) hips. Recent high-tech developments in hard metal alloys made hip components with smooth components, so a cup and head could fit together perfectly.

The new MoM hip was well-praised in the medical community, and marketed heavily as an ideal option for younger, more active patients. It was promoted as having a longer life than other hip options – 20 years or more. Yet significant problems arose, including:

Aseptic loosening: The cup becomes loose for reasons other than infection, requiring revision surgery.

Bone loss: The release of metal ions is suspected to cause osteolysis and inhibit or reverse the bony ingrowth process that holds the devices in place. Many MoM recipients first report great results, then later need revision surgery.

Metallosis: This serious reaction to the accumulation of metal ions or metal debris in the body, metallosis can result in tissue death, pseudotumors and bone degradation.

Neurological problems: Long-term exposure to cobalt and chromium ions can lead to headaches, memory issues, metallic taste in the mouth and cardiac abnormalities.

The FDA is currently gathering information about MoM hip systems, including information about adverse effects of increased levels of cobalt and chromium in the blood stream.

Current MoM hips with alleged injuries include the Zimmer Duron Cup, the DePuy ASR, the DePuy Pinnacle and the Wright Conserve.

If you or a loved one is currently suffering from a MoM hip replacement, contact Robert D Rowland.

A look back at thalidomide – 50 years later

Posted on February 17th, 2012 by Robert D. Rowland

Recently the FDA office of Women’s Health released a message authorized by Margaret Hamburg, M.D. about the beginning of the FDA and Thalidomide. It was called “one of the biggest medical tragedies of modern times.” Introduced as a sedative drug in the late 1950s, thalidomide was commonly used to treat the symptoms of morning sickness. From 1957 until 1961 it was sold across the world, but was taken off the market after being found to cause a number of birth defects. More than 10,000 children in 46 countries were born with deformities. These were the famous “flipper babies”.

Yet thalidomide never had a significant impact on the United States. Why? Because before it could reach the market in the U.S., pharmacologist and M.D. Frances Oldham Kelsey refused to give the Food and Drug Administration (FDA) approval to Richardson-Merrell to market thalidomide. She strongly believed further studies were needed. Kelsey discovered that although thalidomide was being used across the globe, it hadn’t received much testing; In fact, it hadn’t even been tested on pregnant animals. Her decision to deny FDA approval exemplified the need for scientific product development, regulation and review.

In the aftermath of the thalidomide tragedies, the United States Congress enacted the Kefauer-Harris amendments in 1962 requiring proof of safety and efficiency before a drug can receive approval for sale in the U.S.

This turning point led to a new era of medical responsibility and science that has continued to this day. All new drug applications must demonstrate “substantial evidence” of the drug’s efficacy for a marketed indication, in addition to the existing requirement for pre-marketing demonstration of safety.

It’s funny to hear politicians argue that government regulation is holding back our economy. FDA regulation is holding back pharmaceutical companies who, in their rush to market, put profits over people. We still need a strong FDA, “one endowed with the necessary resources to ensue smart, sound, and science-based regulation”.

Contact Robert D. Rowland here.

GHAR Sponsors Price of Freedom Gala to aid wounded military members

Posted on February 13th, 2012 by The Firm

GHAR is once again proud to sponsor the Joshua Chamberlain Society in its second annual Price of Freedom Gala on February 18, 2012. Held at the Renaissance Grand Hotel in St. Louis, the Price Of Freedom Gala is a military-inspired evening at a Marine Mess Night to benefit the Joshua Chamberlain Society’s efforts of providing aid for severely wounded military service members and the families of killed-in-action members of our military.

The evening will honor current JCS heroes as it raises funds to support additional heroes. The formal evening will include silent and live auctions, a seated dinner and a premium open bar.

For more information on the Price of Freedom Event visit http://www.priceoffreedomgala.org/

Please visit the Joshua Chamberlain Society at http://www.chamberlainsociety.org/ to learn more about this extraordinary organization and to help donate to aid severely wounded military service members and the families of killed-in-action members of our military who sacrificed all in our service.

View the 2012 event program here:
jcs2012programfinal