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Category: Defective Medical Device

Defective Medical Device - Bisnar Chase Blog

There are a variety of medical implants such as hip and knee replacements, or vaginal mesh implants, that have been created with potential dangers to their users. Bisnar Chase provides updates on defective medical devices that can be dangerous to keep our readers educated on the dangers of these products.

Boston Scientific Recalls Venous Stents for Risk of Serious Injuries

By D L on May 28, 2021 - No comments

Boston Scientific Recalls Venous Stents for Risk of Serious Injuries

Medical device manufacturer Boston Scientific has recalled 31,798 Vici Venous Stent Systems because of a risk of injury or death. According to an alert issued by the U.S. Food and Drug Administration (FDA), the federal agency that regulates medical device safety, the recalled Vici SDS and Vici RDS Venous Stent Systems are used to treat blocked veins or obstructions in narrow veins.

The alert states that the stents could potentially migrate or move out of place from where they were initially implanted, causing issues and potentially dangerous complications. …Read the rest »

 

FDA Warns Surgical Mesh in Breast Implants Could Pose Greater Risks

By D L on April 9, 2021 - No comments

FDA Warns Surgical Mesh in Breast Implants Could Pose Greater Risks

The U.S. Food and Drug Administration (FDA) is informing patients, caregivers and healthcare providers that certain surgical mesh products used in implant-based breast reconstruction could pose a higher risk of complications or problems for those who get them. According to the FDA alert, these acellular dermal matrix or ADM products could cause side effects and complications. …Read the rest »

 

Boston Scientific to Pay $188.7 Million to Settle Claims That it Deceptively Marketed Vaginal Mesh Devices

By D L on March 26, 2021 - No comments

Boston Scientific to Pay $188.7 Million to Settle Claims That it Deceptively Marketed Vaginal Mesh Devices

Boston Scientific Corporation has agreed to pay $188.7 million to settle claims by most U.S. states that it deceptively marketed its transvaginal mesh devices to women. According to a Reuters news report, the settlement with 47 states and Washington D.C. was announced this week by several state attorneys general. As part of this settlement, Boston Scientific also agreed to describe the safety and risks of using the surgical mesh devices more accurately to consumers. …Read the rest »

 

FDA Warns Plastic Component Count Break in Stryker’s STAR Ankle Implants

By D L on March 19, 2021 - No comments

FDA Warns Plastic Component Count Break in Stryker's STAR Ankle Implants

The U.S. Food and Drug Administration (FDA) today issued a warning regarding STAR ankle implants, which were previously made by Stryker, saying that there is a potential that the plastic component in these devices could break. According to the FDA alert, there is a “higher-than-expected” risk of the polyethylene or plastic component of the device breaking as early as three to four years after implantation, which can lead to surgery in order to repair it or a mandatory replacement. …Read the rest »

 

C.R. Bard to Pay $60 Million for Deceptive Marketing with Vaginal Mesh Devices

By Brian Chase on October 2, 2020 - No comments

Boston Scientific to Pay $188.7 Million to Settle Claims That it Deceptively Marketed Vaginal Mesh Devices

C.R. Bard, a company that failed to properly inform women about the dangers of transvaginal mesh devices, will be required to pay $60 million as part of a settlement announced by state attorney generals across the United States. According to a CTV news report, the money from C. R. Bard and its parent company, Becton, Dickinson and Company, will be distributed among 48 states and the District of Columbia. …Read the rest »

 

Bayer Sets Aside Nearly $1.47 Billion for Essure Settlements

By Brian Chase on August 6, 2020 - No comments

Bayer Sets Aside Nearly $1.47 Billion for Essure Settlements

Bayer has said it is progressing with its settlement talks with attorneys for thousands of women who were injured by Essure birth control implants. According to news reports, the company announced that it has set aside $1.47 Billion for potential settlements involving 32,000 lawsuits in the United States. Bayer said in its second-quarter earnings report on Aug. 3 that discussions on potential settlements in connection with Essure “recently intensified and have made good progress in recent weeks.” …Read the rest »

 

Women in the UK Unite to Stop of the Use of Vaginal Mesh Devices

By Brian Chase on July 6, 2020 - No comments

FDA Warns Surgical Mesh in Breast Implants Could Pose Greater Risks

Women in the United Kingdom have united to stop potentially dangerous vaginal mesh surgical procedures from being offered at clinics and hospitals, according to a news report in Science Times. This is a procedure that has caused thousands of women chronic pain and a range of other health complications, leaving many disabled and in need of multiple surgeries. …Read the rest »

 

Ovation Abdominal Stent Graft Recalled After Five Patient Deaths

By Brian Chase on June 18, 2020 - No comments

Boston Scientific Recalls Venous Stents for Risk of Serious Injuries

The U.S. Food and Drug Administration (FDA) has issued a Class I recall for the Endologix Ovation iX Abdominal Stent Graft System because of the risk of severe injury or death. According to an FDA alert, the recall involves about 5,403 devices that were distributed in the United States since August 2015. The recalled products have a manufacturing defect that has been linked to five deaths. …Read the rest »

 

FDA Says Essure Birth Control Devices Were Linked to 15000 Adverse Reports in 2019

By Brian Chase on May 1, 2020 - No comments

Lawsuits Claim Bayer Covered Up Essure Injury Claims

The U.S. Food and Drug Administration (FDA) on April 24th released data from more than 15,000 new adverse event reports in 2019 regarding Essure birth control devices. According to the report, the most common reports involved surgery to remove the Essure device, chronic pain and menstrual irregularities. Essure has consistently had problems over the last 17 years. …Read the rest »

 

Boston Scientific Settles Transvaginal Mesh Case for $21.5 Million

By Brian Chase on March 16, 2020 - No comments

Boston Scientific Settles Transvaginal Mesh Case for $21.5 Million

Boston Scientific has agreed to settle a transvaginal mesh class action lawsuit that was brought by women in Canada for $21.5 million. According to news reports, the proposed settlement involves about 325 women whose share of the settlement money will depend on the severity of their medical issues. A final approval of the settlement is expected in June. …Read the rest »

 



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