The medical industry is still absorbing the shock from the Food and Drug Administration’s 2019 announcement that more than 56,000 reports of surgical stapler defects from 2011 through 2018 had been kept from public disclosure in a hidden FDA database. Many of those reports included references to excess bleeding and other surgical complications that resulted…
Over the past eight years, juries across the country have rendered many verdicts against vaginal mesh manufacturers, after finding the devices caused severe and life-threatening complications. In one of the latest pelvic mesh trials, Ethicon – a subsidiary of Johnson & Johnson – was hit with an $80 million judgement regarding its Prolift mesh implants,…
Across the U.S., over 1 million people undergo surgery to repair hernias annually. The majority of hernia repairs are done by reinforcing the affected areas with a man-made synthetic mesh. According to the U.S. Food and Drug Administration (FDA), 33% of patients report adverse events with hernia mesh. These complications, which often manifest as severe…
3M Combat Arms earplugs were standard-issued to thousands of service members deployed to Iraq and Afghanistan from 2003 to 2015. However, the manufacturer was sued by the U.S. government and competitor Moldex-Metric Inc. when defects were discovered that could cause tinnitus ringing in the ears and hearing impairment. The Veterans Benefits Administration treats over a…
Over one million hernia repairs are performed in the U.S. each year. Hernias occur when an organ, intestine or fatty tissue squeezes through a hole or weak spot in the surrounding muscle or connective tissue. Often times mesh is used to help repair the hernia. There are three types of mesh used, and the most…
On December 4, 2018, the U.S. Food and Drug Administration announced a proposal that it intends to improve the review process for new low to moderate-risk medical devices. It remains to be seen whether the proposal will adequately protect consumers, or whether the form it will take if it is ultimately enacted. FDA review…
As a neurosurgeon who focuses mainly on spine surgery, I sometimes use medical devices like pedicle screws and intervertebral cages to treat spinal instability. Watching the Netflix documentary “The Bleeding Edge” made me wonder what the misuse of medical technology means for patients and for doctors. According to the video’s teaser, “This eye-opening look at…
The Philadelphia Inquirer (8/3, McCullough, 1.07M) reported that scientists agree that breast implants with textured surfaces, rather than smooth ones, can cause “breast implant-associated anaplastic large-cell lymphoma.” Back in 2011, the Food and Drug Administration estimated the risk as less than one in 500,000, but “the risk after a decade of wearing the devices could…
Inequality between men and women has always been prevalent, but it is especially evident in the medical field, particularly with drugs and devices. Women have often been excluded from Phase 1 Clinical Trials in the past, which prevents pharmaceutical companies and device manufacturers from understanding the effects their products may have on women. Even when they…
Johnson & Johnson was in the courtroom quite often last year. Bloomberg News (3/28, Fisk, Feeley, 2.41M) just reported that J&J “had a year for the record books – it lost six of last year’s seven largest jury verdicts in the US over product defect claims. Now in 2017, things are looking much the same for this…