More Bad News for Smith and Nephew

Smith & Nephew continues to issue additional recalls for its defective hip implant devices. By now, Smith & Nephew has established a clear pattern of manufacturing faulty and dangerous hip devices that harm rather than help innocent users of those products. In June of 2012, Smith & Nephew issued a recall of its R3 Acetabular System hip implant, followed by a voluntary market withdrawal of the Birmingham Hip Resurfacing (BHR) Femoral System in June of 2015. In 2016, Smith & Nephew was forced to recall three additional hip implant products.

In August of 2016, Smith and Nephew recalled its Tandem Bipolar Hip System because of a manufacturing error that caused the device to fall apart inside the patient’s body, often within just a few weeks of surgery. Smith & Nephew manufactured the bipolar shells for this device out of specification. In issuing the recall, Smith & Nephew admitted that its negligence in manufacturing these devices could lead to a failure of the device that would require a revision surgery. They were forced to make this admission after product complaints and clinical study data showed a much a higher rate of problems for this device when compared to similar hip implants on the market.

In November of 2016, Smith and Nephew recalled its Modular SMF hip stem and Modular REDAPT hip systems. They again admitted that patients implanted with these devices may face a greater risk of the need for revision surgery based on data they collected.  Most of the problems were “metal related.” This means that like other Smith & Nephew metal-on-metal hip implant devices, many users of this product experienced dangerously high levels of chromium and cobalt in their blood. This forced innocent users of this defective product to undergo unnecessary revision surgeries.

Sadly, although time marches on, the story for Smith & Nephew remains the same. By continually putting profits ahead of the safety of individuals using its defective products, those persons are put at risk for suffering from harmful medical consequences. Our experienced lawyers fight for individuals who have been harmed by defective products. If you or a loved one has been injured or required revision surgery following a Smith & Nephew or other defective hip implant, the attorneys at the Yost Legal Group will investigate your lawsuit claim. For a free consultation, please call us at 1-800-YOSTLAW.

 

FDA’s Black Box Warning Labels Essure as Dangerous Device

The FDA announced on Monday, 2/29 that it will recommend a “black box warning” label for the Essure permanent birth control device. According to the FDA website, a black box warning label is “designed to call attention to serious or life-threatening risks” associated with a prescription drug or medical device. The FDA also instructed Essure manufacturer Bayer Pharmaceuticals to conduct additional studies in order to better understand the risks of prescribing this permanent contraception device to women.

The Essure permanent contraception device was approved by the FDA in 2002 and marketed as a non-surgical, permanent birth control solution for women. Bayer Pharmaceuticals, the manufacturers of the Essure implant, told women that this device would be a safe and effective alternative to laparoscopic sterilization.

According to Reuters, there are more than 500,000 women in the United States that are using the Essure device. Since 2002, the FDA has received more than 5,000 serious injury complaints from women using this device. These women have reported device failures, such as fracturing or migration inside the body, as well as autoimmune responses, such as unexplained but significant weight gain, skin conditions, hair loss and abnormally heavy menstrual cycles.

If you suffered injuries after receiving an Essure implantable sterilization device and want to learn more about your legal options, call The Yost Legal Group at 1-800-YOST-LAW (967-8529). When you call, you will speak with one of our experienced Defective Medical Device attorney absolutely FREE.

The attorneys at The Yost Legal Group are experienced professionals ready to investigate your claim with compassion and determination. Call today for a free consultation.

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