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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.

Ovation Abdominal Stent Graft Recalled After Five Patient Deaths

By Brian Chase on June 18, 2020 - No comments

Ovation Abdominal Stent Graft Recalled After Five Patient Deaths

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

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

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 »

 

Study Says FDA Should Have Banned Pelvic Mesh Much Sooner

By Brian Chase on March 3, 2020 - No comments

Study Says FDA Should Have Banned Pelvic Mesh Much Sooner

Researchers with the U.S. Food and Drug Administration (FDA) who conducted a long-term study of women implanted with transvaginal mesh to treat pelvic organ prolapse (POP) concluded that the FDA should have banned the products sooner than it did. According to a report on Mass Device, the study of 54,194 women in New York State revealed that women treated with mesh had an 8.8% risk of re-intervention five years post-surgery compared with 6.3% in the same size group of women treated differently for the same condition. …Read the rest »

 

Mavidon Recalls All Medical Products After Baby Contracts Bacterial Infection

By Brian Chase on January 3, 2020 - No comments

Mavidon Recalls All Medical Products After Baby Contracts Bacterial Infection

Mavidon, a medical device manufacturer that specializes in products for the application of electrode leads and therapy products, has recalled a number of its products for potential bacterial contamination. According to a news release from the U.S. Food and Drug Administration, the company is notifying customers, hospitals and clinics to stop using Lemon Prep, Pedia Prep, Wave Prep, Cardio Prep Single use cups, Collodions, Collodion Remover, Medical Adhesive Remover, Acetone, and all products manufactured by Mavidon right away due to contamination with Burkholderia cepacia (B.cepacia). …Read the rest »

 

Oregon’s Attorney General Sues Johnson & Johnson for Deceptive Marketing of Vaginal Mesh Devices

By Brian Chase on December 23, 2019 - No comments

Oregon's Attorney General Sues Johnson & Johnson for Deceptive Marketing of Vaginal Mesh Devices

Attorney General Ellen Rosenblum has filed a lawsuit against Johnson & Johnson for alleged deceptive marketing of its transvaginal mesh devices. According to a news report, the suit also names J&J’s subsidiary Ethicon Inc. Rosenblum alleges the companies deceptively marketed the surgical mesh devices by failing to disclose dangerous complications. So far, at least 3,700 Oregon women have had the devices implanted without enough information about their risk and benefits, the lawsuit states. …Read the rest »

 

Four Important Questions to Ask Your Doctor About Allergan Breast Implants

By Brian Chase on November 15, 2019 - No comments

Women Say Allergan is Using Dirty Tricks to Ward Off Liability

If you received Allergan textured breast implants, you are likely extremely concerned about developing breast-implant-associated anaplastic large cell lymphoma (BIA-ALCL), a cancer of the immune system, which has been linked to textured implants. Last summer, Allergan Pharmaceuticals announced a recall of its textured Biocell breast implants and tissue expanders. So far, 33 women have died after developing cancer linked to the textured breast implants. …Read the rest »

 

Surgical Staplers Recalled After Death and Serious Injuries

By Brian Chase on November 4, 2019 - No comments

Surgical Staplers Recalled After Death and Serious Injuries

Johnson & Johnson is issuing a recall for a surgical stapler after reports that seven patients were seriously injured and one died. According to news reports, the medical device, manufactured by Johnson & Johnson’s Ethicon unit, is used to simultaneously cut and staple tissue back together during surgery. However, problems with a part led to staples failing to properly close incisions, the U.S. Food and Drug Administration (FDA) said. …Read the rest »

 

FDA Issues Class I Recall for Heart Valves After Reports of Injuries and Death

By Brian Chase on August 23, 2019 - No comments

FDA Issues Class I Recall for Heart Valves After Reports of Injuries and Death

The U.S. Food and Drug Administration has slapped a Class I classification on its recall of Edward Lifesciences’ EW Sapien 3 Ultra delivery system as a result of several injuries and at least one report of a death associated with its use. According to a news report, this recall comes a week after the company’s Sapien 3 and Sapien 4 Ultra heart valves’ received approval for use in surgeries with low death risk. The Sapien 3 Ultra delivery system is designed to deliver a transcatheter heart valve to replace a diseased aortic valve without open-heart surgery. …Read the rest »

 

Health Canada Bans Biocell Macro-Textured Breast Implants Linked to Rare Form of Cancer

By Brian Chase on June 5, 2019 - No comments

Six Women Sue Allergan Alleging Cover-Up of Breast Implant Cancer Risk

Health Canada has barred the sale of a brand of breast implant that has been linked to a rare form of cancer. According to a CBC news report, Health Canada has suspended the licenses of Ireland-based Allergan for its Biocell implants after finding significantly higher rates of a type of non-Hodgkin lymphoma among patients implanted with the macro-textured breast implants. Biocell implants are the only textured breast implants available in Canada. …Read the rest »

 



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