In December, medical device giant Zimmer Biomet issued what has become a Class-I recall of one of their most popular shoulder implants, the Comprehensive Reverse Shoulder. However, the company did so without notifying the thousands of patients that had received the devices.
Now, many are questioning the company’s handling of the recall, and asking if Zimmer could have done more to protect patients from potential implant failures and the need for painful revision surgery.
With the use of oral anticoagulants growing rapidly, the debate rages on about whether these drugs have a net positive effect or carry risks that outweigh the benefits.
Last week, the maker of Xarelto touted the results of a new study showing the drug may reduce the occurrence of major cardiac events. This came on the heels of a consumer safety group warning of increased dangers of internal bleeding from the entire class of blood thinners that also includes Pradaxa and Eliquis.
A leading consumer drug safety advocate warned last week that a popular class of drugs designed to treat hepatitis C may carry significant risks for liver damage and death, DrugNews has learned.
The report comes just months after the FDA itself issued a different warning on the new class of Hep C drugs, called direct-acting antivirals, that they may cause a return of Hepatitis B.
In recent months, orthopedic device maker Stryker has warned doctors that several models of its metal hip implants may be defective, causing device separation, failure and the need for revision surgery.
This was followed by a mandatory Stryker hip recall in Canada last September due to a higher than expected number of patient complaints.
Abdominal hernias are a common injury that will affect more than 25% of all men and even some women during their lifetime. And, for the most part, they are resolved with a simple surgery. Each year, more than 350,000 people in the United States undergo hernia repair procedures.
Hernia repair may be performed with only sutures. However, for over 50 years, doctors have done most hernia repairs with a lightweight plastic mesh that bonds to the abdominal wall with scar tissue to add strength.
With a blood thinner market estimated at over $6 billion per year, three manufacturers have been fighting it out to get their drugs – Pradaxa, Xarelto and Eliquis – prescribed to as many patients as possible.
Never mind that these drugs have been linked to serious internal bleeding and death; or that, to this day, thousands of lawsuits have been filed and billions of dollars will be paid out to victims. The makers are determined to increase their market share by any means necessary.
Since the blood thinner Pradaxa burst onto the scene in 2010, experts have debated whether the drug is safer or riskier than stalwart Coumadin, even as thousands of patients have died or been hospitalized due to internal bleeding.
In 2014, faced with more than 4,000 patient lawsuits, Pradaxa maker Boehringer Ingelheim decided to pay $650 million to settle cases rather than face charges in a public court of law. And, by all accounts, the company thought that was the last of the Pradaxa lawsuits.
Last week, DrugNews reported on a warning issued by Stryker Orthopedics for its LFit V40 femoral head used on several models of its hip replacement implants. Although the warning was sent only to doctors, experts believe the safety risks could result in a worldwide recall.
Now, Canada’s top health authority has issued a formal recall of these hip implant components, citing a higher-than-normal number of patient injuries.
Stryker Orthopedics, a market leader in hip and knee replacement implants, has sold millions of devices in recent decades. However, they have also recalled several of those implants due to serious health risks, with at least four recalls issued since 2009.
This summer, Stryker took the first step toward what many believe may be their latest hip recall when they issued a private letter to doctors warning of risks with their LFit V40 femoral head, which is used on several hip replacement models.
There’s been much debate about the safety of the anticoagulant Xarelto since it first hit the market in 2011. Despite claims the drug is safer than traditional warfarin, studies and thousands of patient lawsuits suggest it can cause serious internal bleeding with greater chances of death.
Last year, reports surfaced that a key device used in the initial clinical trial testing of Xarelto was defective, calling into question whether the results were valid.
Amid recent questions over the safety of Inferior Vena Cava blood clot filters, two new reports warn of their immanent dangers and a federal judicial panel has disclosed a surge in lawsuits filed by injured patients.
Inferior Vena Cava (IVC) filters are tiny, metal vein implants that catch blood clots before they reach the heart or lungs. They are generally used in emergencies or for those who can’t take blood thinners. Each year, they are used in around 250,000 patients.
This week, DrugNews highlights eight recalls announced by the U.S. Food and Drug Administration during the month of September. Seven of these involved food products while one dealt with a line of injectable drugs.
Below you will find more information on the recalls, and what consumers need to know for their safety.