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.
Amid mounting FDA warnings that the diabetes drug Invokana may cause kidney damage, a new study out last month confused the issue by suggesting the drug may actually slow kidney damage.
The data comes as the growing number of lawsuits against the manufacturer of Invokana, Johnson & Johnson, has led to victims requesting that cases be consolidated to a central federal court for quicker handling.
Last month DrugNews reported that the FDA had delayed approval of an antidote for new age blood thinning drugs Eliquis and Xarelto due to questions with the manufacturing process.
Now, as the number of patients injured or killed by uncontrollable internal bleeding continues to rise, new data suggests the experimental antidote could help save as many as 90% of them from the risk.
In this week’s installment of the DrugNews FDA Recall & Warning Recap, we look at eight actions taken by the agency over the past week. These ranged from simple food-based allergies to bacterial presence to lead contamination in foods.
Here is more information on the most recent recalls and what consumers should know.