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The power morcellator, a surgical device used to mince large masses of tissue inside the body so the material can be extracted through small incisions, has been the center of a debate in the medical community since the Food and Drug Administration (“FDA”) discouraged its use in April, 2014. The FDA discouraged the use […]

At the Food and Drug Administration’s Center for Devices and Radiological Health, the new year started off with an approval of the first therapeutic weight loss option for obese patients since 2007. The device – the Maestro Rechargeable System – was given a thumbs-up following a scientific study of a […]

Safeguarding, streamlining, strengthening the clinical trial process is one of three of the Food and Drug Administration’s primary goals for 2015. So states an 11-page document titled 2014 – 2015 Strategic Priorities. The other two goals focus on 1) striking a better balance between data collection requirements and the time […]

Shareholders have sued the maker of a surgical robot claiming the company has “grossly underreported” injuries and deaths attributed to the da Vinci. The 67-page shareholder derivative complaint was filed by the city of Birmingham and Alabama’s Relief and Retirement System naming Intuitive Surgical of Sunnyvale, California, the maker of […]

A simple hernia repair surgery. Most doctors sell it as a walk in the park depending on the hernia and certainly the standard of care is to use surgical mesh. But a new study from the American College of Surgeons (ACS) finds the simple surgery for ventral hernia repair can […]

In December, the U.S. Food and Drug Administration (FDA) announced a recall of certain guidewires made by Medtronic, Inc. Patient complication reports were reported to the FDA and the company concerning the coating on the wire’s surface that had the potential to detach and delaminate. Medtronic began notifying hospitals and […]

The Food and Drug Administration (FDA) finally seems to be taking something other than a head-in-the-sand approach to monitoring medical devices after they are approved and in use by patients. The U.S. does not monitor medical devices after they go through the FDA’s approval process. Since most medical devices are […]

Cook Medical is once again shipping the Zilver PTX Drug-Eluting Peripheral Stent to doctors and hospitals in Europe, Japan and in the U.S. following a global recall due to at least one fatality. The stent was voluntarily recalled after the company received 13 complaints of a faulty delivery system. Specifically, […]

It is a startling revelation concealed in court documents – C.R. Bard, one of the six primary plastic mesh manufacturers – knowingly sold vaginal and hernia mesh that was made of a material unsuitable for human implantation. What’s worse was that court documents show executives knew the Marlex polypropylene should […]

It is so interesting to delve into how a corporation thinks. Not in that they think like a person – even though the U.S. Supreme Court recently gave corporations First Amendment rights – but in that they groupthink. Take the case of transvaginal mesh. A trial is underway in Superior […]