Vaginal mesh problems show need for more regulation

The growing number of patients reporting injuries from such defective products as vaginal mesh implants and poorly constructed hip implants has caused the Food and Drug Administration’s head regulator of medical devices to admit that tighter regulations are needed.

The FDA, he stated, should be given further authority so that it can prevent such unsafe products from being placed on the market to begin with, thereby saving thousands of innocent people from debilitating injuries and even loss of life.

Currently, the agency is not given the power to prevent manufacturers from marketing new products even when their design is based on prior products which have already been recalled for injuring people.

This unfortunate loophole allows manufacturers who have already injured many in the past to slightly repackage known defective items and inflict them on an unknowing public again in their endless quest for massive profits, even if they come at the expense of the public’s health and safety.

Members of Congress sponsoring legislation to fix this loophole point to all the health problems caused by vaginal mesh implants and hip replacements which were marketed by Johnson & Johnson. These products were approved despite the existence of many questions and concerns about products using earlier versions of essentially the same technology.

The Johnson & Johnson vaginal mesh implants, for example, were approved despite their designs being based on a previously recalled defective product sold by Boston Scientific Corp.

As a result, many of the approximately 300,000 women using such devices have suffered weakened pelvic muscles and other serious complications, resulting in hundreds of product liability lawsuits so far.

Many say that the existing lawsuits over vaginal mesh implants may be just the tip of the iceberg, as more patients experience serious health problems.

Source: Bloomberg News, “Medical Device Loophole Needs Closing by Congress, FDA Device Chief Says,” Alex Nussbaum, Feb. 28, 2012