Happy Fourth of July

Happy Independence Day! As always, this most American of holidays will be marked with red, white and blue flags, fireworks, parades, and backyard barbecues across the country. No doubt Americans across this nation will celebrate, showing a great deal of emphasis on the American tradition of political freedom.

Independence Day is a patriotic holiday for celebrating the positive aspects of the United States. Many politicians appear at public events to show their support for the history, heritage and people of their country. Above all, people in the United States express and give thanks for the freedom and liberties fought by the first generation of many of today’s Americans.

On this Independence Day, we wish you a safe and Happy Fourth of July.

Former OtisMed CEO Sentenced to Two Years in Prison

Former OtisMed Corp., CEO Charlie Chi, a subsidiary of Stryker Corp.,  was sentenced to two years in prison for distributing knee replacement surgery guides without Food and Drug Administration (FDA) approval.

Stryker Corp. purchased OtisMed Corp. in 2009. The former CEO plead guilty to distributing the devices despite the FDA’s rejection of the company’s application for marketing clearance. Mr. Chi will also face a year of supervised release and a $75,000 fine, all for distributing the OtisKnee cutting guide after the FDA denied its 510(k) application.

A federal judge has fined the company $34.4 million and ordered $5 million in criminal forfeiture. OtisMed has also already agreed to pay $41 million in a separate but related civil settlement. As part of that settlement, OtisMed was excluded from participating in all federal healthcare programs for a period of 20 years and Stryker will work with government officials to ensure its other devices are in compliance.

Smith & Nephew Issues Urgent Medical Device Market Removal

Smith & Nephew is voluntarily removing from the market all lots of 46mm diameter and smaller femoral heads and corresponding acetabular cup components of the Birmingham Hip Resurfacing (BHR) System due to observed revision rates which are higher than established benchmarks.

This comes after data from the United Kingdom’s National Institute for Health and Care Excellence (NICE) found that smaller sizes of the Birmingham Hip Resurfacing System had revision rates that exceed its benchmarked expectations. Smith & Nephew is also advising against any use of the BHR system in women. However, the company is not advising patients with the now-contraindicated implant to undergo proactive revisions. Patients experiencing unusual symptoms are advised to contact their surgeon. Patients are not required to take any new action and surgeons can continue their current patient follow-up protocol.

Chief Medical Officer Andrew Weymann M.D. said in a news release, “Patient welfare is Smith & Nephew’s top priority. Based on our analysis of our most recent data, we are taking the necessary steps to ensure the Birmingham Hip Resurfacing is only used in those patient groups where it has demonstrated strong performance. These represent the vast majority of current patients.”

 

 

 

 

Updated Schedule for Pending DePuy Pinnacle and Wright Conserve Hip Cases

The next DePuy Pinnacle trial is set for January 2016 in Dallas, Texas. The first Wright trial is tentatively set for August 2015 in Atlanta, Georgia. Additionally, a second Wright trial is set for November 2015 in Los Angeles, California.

Additionally, two Zimmer Durom Cup (another metal on metal hip) cases are headed to trial this month in Los Angeles, California and Newark, New Jersey. Both Depuy and Wright will be watching these Zimmer trials, which hopefully will result in positive outcomes for Plaintiffs that have had a mixed track record in metal on metal hip trials to date.

Metal-on-Metal Hips Linked to Illness

Patients with metal-on-metal hips around the world have growing concerns about the problems associated with the all-metal devices. When first introduced to the market, metal hips were touted as being more durable and suitable for relatively younger aged or more active patients, with the promise of lasting 20 to 25 years, but many have failed prematurely.

In recent years, metal-on-metal hip implants have been used in about one-third of the approximate 250,000 hip replacements performed annually in this country. “The devices, whose ball-and-socket joints are made from metals like cobalt and chromium, became widely used in the belief that they would be more durable than previous types of implants.”

The Sydney Morning Herald reports that hundreds of Australians with metal hip implants are worried about their hips leaching cobalt and chromium particles into their bodies. Many patients report similar symptoms, including nausea, vertigo, headaches, heart problems and more. Some injured patients have joined a class-action lawsuit underway in Federal Court. The lawsuit has been filed against Johnson & Johnson over its DePuy ASR hip implant, which the company recalled in August 2010, due to higher than expected failure rate. Many other patients with other brands of all-metal hip implants have complained of the same issues, although they are not involved in this litigation.

The cause and the scope of the problem are not clear. But recent studies indicate that in some cases the devices can quickly begin to wear, generating high volumes of metallic debris that is absorbed into a patient’s body. That situation can touch off inflammatory reactions that cause pain in the groin, death of tissue in the hip joint and loss of surrounding bone.

The Sydney Morning Herald reports on the story of Di Harvey, a former nurse who was implanted with a Birmingham Hip Resurfacing system in 2003. In 2010, she went to see an orthopedic surgeon for back pain. She had been suffering from the pain for years; it had been attributed to a “pinched nerve”. The surgeon, however, told Harvey her pain was transferred pain from her hip implant. The metal hip failed and needed to be replaced through a “revision” surgery. Harvey was implanted with a ceramic device but her problems continued..Her right hip caused her to favor the left leg, causing knee pain; she later received a knee implant as well.

Harvey’s following symptoms were worrisome. “I developed a hacking cough,” she said. “I got very sick, began vomiting bile every day. I had heart palpitations. I felt if I over-exerted myself I would drop dead.” She researched her symptoms further and learned about the growing concern of metal poisoning with metal hips. In June 2011, the Medical Journal of Australia published an article stating that it was an “emerging clinical problem”. The authors wrote that the metal devices released “a variety of metal ions into local tissue and [into] the general circulation…” and higher levels of cobalt were linked to hand tremors, depression, vertigo, hearing loss and heart problems.

“I have got rid of my BHR hip, but I have been told that once the cobalt and chromium get into your body the damage has been done.” Harvey says.

S & N Field Safety Notice Issued for Certain Sub-groups of Patients

According to the Food & Drug Administration (FDA), metal-on-metal hip implants have unique risks in addition to the risks of all hip implants. The metal “ball” and socket” grinds together as the patient implanted with a metal hip system walks or runs. The implant can shed tiny particles of chromium and cobalt around the hip or particles can potentially enter into the patient’s bloodstream. Over time, additional complications like inflammation, chronic pain, decreased mobility, tissue death, and bone loss may force a patient to undergo revision surgery.

Smith & Nephew is a medical device company that manufacturers the Birmingham Hip Resurfacing (BHR) system. The BHR is a metal-on-metal hip system, also the first metal hip implant to be approved in the United States. Other manufacturers have mimicked the BHR hip system, and currently faced with thousands of metal hip implant lawsuits.

In January 2015, Smith & Nephew released an urgent field safety notice for its BHR system. The field safety corrective action was undertaken as certain sub-groups have been identified to be at increased risk of adverse outcomes if fitted with the system. The safety notice informed patients that more information would be available on the company website. Patients who visited the website could not find any information or mention of the urgent field safety notice issued by the company.

It seems rather suspicious an urgent field safety notice would be issued directing patients to the company website and then, have essential information unavailable to the patient.

Metal-on-Metal Hip Implants Pulled From Market

Metal-on-metal hip replacements have recently been associated with serious side effects, including a significantly higher than expected rate of failure compared to other hip implants. The metal-on-metal design may also leak toxic chemicals into the body, increasing a hip recipient’s risk of metal poisoning and hip implant failure. An estimated 500,00 Americans have metal-on-metal hip implants, but many have no clue that they could be at risk of a severe side effect.

High failure rates and toxicity concerns have prompted the U.K. to ban metal-on-metal hip implants in hip replacement surgeries performed at National Health Service (NHS) hospitals. The NHS is the publicly funded health care system in the U.K.

The National Institute for Health and Care Excellence (NICE), issued the guidance to hospitals following alarming results from a recent study, according to The Telegraph.

The study of 17,000 patients with the devices found that some of the metal-on-metal brands had failure rates as high as 43 percent. Not only do early failures require patients to get follow-up hip replacement surgeries, called revisions, but health care professionals worry the metal hips may release toxic particles into the bloodstream.

New Warnings Issued for Smith & Nephew Birmingham Hip Resurfacing (BHR)

Smith & Nephew has issued a safety alert for its Birmingham Hip Resurfacing (BHR) system. Smith & Nephew issued a notice updating the instruction for use (IFU), after the manufacturer confirmed certain population sub-groups have been identified to be at risk of adverse outcomes if fitted with the product.

The urgent field safety notice (FSN) from Smith & Nephew revealed that women patients, men aged 65 or above and patients requiring an implant size of less than 48mm are at greater risk of requiring revision surgery earlier than expected.

It has been confirmed that the IFU changes are applicable to specific catalog numbers of the BHR Resurfacing Head, BHR Acetabular Cup and the BHR Dysplasia Cup, with more detail being available on the Smith & Nephew website. However, the website currently does not provide any information about the urgent field safety notice.

Kevin Timms, a lawyer at Irwin Mitchell’s London office who specializes in providing support to victims of faulty medical products, said: ” The new guidance issued by Smith & Nephew is a welcome step towards preventing certain sub-groups of patients from being at an earlier-than-expected risk of revision.”

“However, it also raises concerns regarding the number of patients who fall into those categories and may have already been fitted with the affected devices. As such, it is vital that the manufacturer works quickly to provide more information regarding the issues, as well as providing an explanation as to why a recall has still not been issued for small BHR implants and why the instructions for use were not updated in 2012 when a revision rate of 11.76% was confirmed in women with a 42mm femoral component. The delay is clearly unacceptable.”

“An issue of this nature is just the latest in a long line to raise concerns regarding the safety of hip replacement devices and many patients will be concerned to see these further concerns being raised.”

“Patients put great faith and trust in the fact that the devices they are being fitted with are safe for use and meet the required standards. An issue of this nature once again calls into question how specific devices are able to make it to market and whether the regulatory system in place is fit for purpose.”

“Every effort must be made to always put patient safety first and it is clear that there are many questions to be answered regarding these issues.”

SUPPLIER CHANGE

We have recently made a difficult decision to close our store as we change suppliers. We feel that God is leading us in another direction. We believe our supplier should be veteran-owned to better suit our needs. This is not a decision made lightly, and we certainly appreciate all your prayers and support, and earnestly desire your prayers right now. We want to fulfill our mission, and we need wisdom for all the decisions involved in this transition.

God has been very good to us. We are one step closer to securing our veteran’s home from foreclosure. This is truly a gift from above considering our veteran is also recovering from revision hip surgery. The additional stress is definitely something he does not need at this point. Please pray for God’s healing and wisdom concerning the upcoming decisions we need to make during this transition.

Long Road to Recovery

Doctors advised our veteran that he was headed down a long road to recovery following revision. Our veteran had 38 staples removed from the incision two weeks after revision surgery. We are thankful the incision was much smaller than originally anticipated by the surgeons. Doctors continue to take necessary precautions to ensure a favorable outcome.

After hip resurfacing surgery, symptoms surfaced that perhaps indicated something was not right with the metal-on-metal hip implant. Complaints of constant pain surfaced almost immediately after surgery. The doctor said to give the hip resurfacing time to heal. Weeks went by before weeks turned into months, and then months turned into years. The pain gradually intensified and interfered with all daily activities.

Revision surgery was required after 3 plus years of excruciating pain from the initial hip resurfacing procedure. Not even close to the 25 to 30 years of quality life promised by the manufacturer. Lawmakers, device makers, and the FDA should take a closer look at the devastation caused by these medical devices given approval without requiring any clinical testing. The FDA has since recommended changes to its policy, but does little to help those seriously injured by metal-on-metal hip implants.