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2300 Main Street, Suite 170
Kansas City, MO 64108
On March 10, 2022, the FDA issued a notification order to Philips Respironics requiring the company to notify patients and others of the company’s June 2021 product recall and the health risks posed by the foam used in the recalled products.
Products in this recall include:
Exactech Lawsuit: Nash & Franciskato along with co-counsel firms Cohen & Malad, LLP, and Maglio Christopher & Toale Law Firm has filed a lawsuit against Exactech, Inc., the maker of the Connexion GXL hip liner implant used in Total Hip Arthroplasty (THA) or hip replacement surgery.
Read the Press Release: Exactech Connexion GXL Hip Liner Implant Lawsuit
Nash & Franciskato has been talking with patients throughout the country who have received the Exactech Connexion GXL implants and suffered injuries associated with excessive wear to the plastic liner insert leading to early device failure.
The Exactech Hip Implant Liner is prone to premature failure, which puts some patients at a higher risk of complications and revision surgery. Exactech’s Connexion GXL hip implant liner, approved for use in primary and revision hip replacement surgeries, has been reported as being prone to a high rate of early failure. Premature failure of the device puts some patients at a higher risk of complications and revision surgery.
Paragard, a popular intrauterine birth control device used by thousands of women, is prone to breakage and fracturing, which can lead to serious complications. And, there is evidence that the maker, Teva Pharmaceuticals, has been aware of this issue since at least 2013.
A medical device recall is when the manufacturer either removes a device or takes corrective action to address a problem with a device that is in violation of the FDA laws, such as when the device is defective and/or a risk to health.
These are some basic FAQs and resources to help you understand medical device recalls.
Surgical mesh has been used to treat hernias since the 1950s. In the 1970s, gynecologists began using it for abdominal repair of pelvic organ prolapse (POP) and in the 1990s for the transvaginal repair of POP.
March 8, 2019. In an article published by Kaiser Health News, we learned that some medical device manufacturers have been using a secret reporting mechanism to let the FDA know of problems with their devices.
The problem? The data is hidden so that neither the public nor doctors are aware of any problems reported.
In 2018, the medical device industry and the FDA came under fire from:
December 20, 2018. FDA Commissioner, Scott Gottlieb, issued a statement on the new steps the FDA will take to strengthen the long-term safety oversight of Essure. In his statement, Gottlieb said the FDA will continue to evaluate the product’s long-term safety profile even after it has been discontinued in the US market.
“Forty-two years ago, Congress passed the law establishing the framework for evaluating the safety and effectiveness of medical devices.”
On Monday, November 26, 2018, the Food and Drug Administration announced that it plans to modernize its current process, the 510(k) clearance pathway, which is how a majority of the medical devices are reviewed and approved by the FDA today.