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FDA 510(k) medical device approval leaves room for error

The FDA frequently uses a medical device approval method called the 510(k) process, used to hasten a new product to market, but a growing list of reported injuries and complaints indicates the process may not be thorough enough. The 510(k) approval is a fast-track method of gaining permission from the FDA to market and sell a new medical device as long as the product is “substantially equivalent” to a product previously sold on the market. No additional clinical tests are required as long as the manufacturer can prove the new device’s similarities to another product. On May 11, an approval letter was ... Read More

Netflix documentary reveals dangers of medical devices

The Netflix documentary The Bleeding Edge, directed by Kirby Dick, casts a dim light on the $400 billion-dollar medical device industry and the regulatory agency charged with protecting consumers against dangerous drugs and medical devices. The documentary focuses on several people who received or were treated with a medical device – from vital devices like hip implants and blood clot catchers to elective ones like breasts implants and contraceptive devices. These patients trusted their devices were safe, but later found the products were never tested for safety and efficacy, learning they were essentially guinea pigs. One patient is an orthopedic ... Read More

Despite reported Injuries, Hernia Mesh Market Expects Growth

Hernia mesh is becoming an increasingly popular method to repair hernias of all types. According to a recent market report on OpenPR.com, a hernia is a “protrusion of an organ through a weak spot in the surrounding connective tissue.” Additionally, that same report says that the use of hernia repair mesh is a consistently growing market. “Globally, the market is growing steadily and it is anticipated to show an exponential growth reaching approximately $8.5 billion in 2022,” the report states. There are several types of hernias, such as inguinal, incisional, and femoral, many of which can be repaired laparoscopically rather than ... Read More

Arkansas Woman Alleges Physiomesh Severely Injured Her

An Arkansas woman who alleges Physiomesh is responsible for her severe injuries has filed a lawsuit against the manufacturer in a case that is now part of a multidistrict litigation (MDL) in the Northern District of Georgia. Jennifer Stone was implanted with a Physiomesh hernia repair mesh on June 29, 2011, for the repair of a ventral hernia. The mesh device, made polypropylene with four additional layers, is designed to bridge the gap of a hernia with the intention of allowing it to heal. Later, Stone says she had no choice but to undergo invasive medical treatments from the complications ... Read More

New device relieves some pressure of mammogram

Women are encouraged to undergo mammogram exams annually for early detection of breast cancer. They are an important diagnostic tool, but many women dread the discomfort of having their breast tissue mashed by the machines. But some relief is on the way. The Food and Drug Administration (FDA) announced that it has cleared the first 2D digital mammography system that allows patients to increase or decrease the amount of compression applied to their own breast before the mammogram x-ray is taken. The device is designed to relieve some of the anxiety or stress about the discomfort from the compression during ... Read More

Alabama Man Sues Maker of Hernia Repair Mesh

An Alabama man has filed a lawsuit against the maker of his hernia repair mesh, blaming the defective device for complications that required an additional surgery. The lawsuit was filed by Bill Tedford, who received the Physiomesh hernia mesh device made by Ethicon, a subsidiary of Johnson & Johnson. According to the Daily Hornet, Tedford’s hernia repair surgery was performed in December 2013. The lawsuit alleges Mr. Tedford’s complications and reactions to the mesh device were so severe, an additional surgery and further medical treatment was required. The complaint says he now suffers permanent scarring as well as other injuries associated with the device. ... Read More

Rapid Growth in Physiomesh MDL

The Physiomesh multidistrict litigation (MDL) has experienced rapid growth in the last month, according to the Judicial Panel on MDL report released on July 17. According to the report, at least 84 lawsuit actions are pending against Physiomesh, 14 of which were added just since June, when 70 actions were pending. In March, there were only 18. Lawsuits state that Physiomesh “is not used in any other hernia repair product sold in the United States” due to it’s unique five-layer design. “The mesh product is composed of a nonabsorbable, macroporous polypropylene mesh laminated between two undyed polyglecaprone-25 films,” the 510(k) approval summary states. “An ... Read More

Is Physiomesh ‘Substantially Equivalent’ to Prior Devices?

Physiomesh, a now-recalled hernia repair mesh, is not substantially equivalent to prior devices despite FDA 510(k) approval, according to lawsuits filed that claim the device is linked to injuries and high revision rates. Physiomesh is a polypropylene mesh that is designed to assist in the repairing of a hernia. The mesh was approved by the U.S. Food and Drug Administration (FDA) using a 510(k) approval, which is a fast-track approval method that allows a product to be marketed as long as it is “substantially equivalent” to a device already approved. Ethicon, a subsidiary of Johnson & Johnson and the maker ... Read More

California Man Joins Bard IVC Filter MDL

A man from California has joined the multidistrict litigation (MDL) involving claims related to IVC filters. The man’s lawsuit claims his IVC filter made by Bard failed, resulting in injury. Clarence M. was given a G2 retrievable inferior vena cava (IVC) filter made by C.R. Bard to help prevent any potential blood clots from traveling to his lungs, which would result in a deadly pulmonary embolism (PE). According to The Daily Hornet, the G2 IVC Filter was surgically placed in Clarence’s vena cava vein May 8, 2010, at a California hospital. Clarence’s lawsuit claims the device maker downplayed the risks of the G2 IVC ... Read More

Ohio Man Files Lawsuit Over Bard IVC Filter

An Ohio man has joined thousands of others with a lawsuit against C.R. Bard over its allegedly defective retrievable IVC filter. Marton F. was implanted with the G2 inferior vena cava (IVC) filter on Feb. 7, 2011. Doctors thought the device would be effective in preventing pulmonary embolism, but a lawsuit filed by the patient alleges the device failed, injuring Marton. IVC filters are shaped like an inverted umbrella, made of simple tines that are designed to catch blood clots before they enter the heart or lungs. The makers of IVC filters, however, have been faced with thousands of lawsuits due ... Read More