Product News and Recalls

FDA approval of transvaginal mesh based on device that was recalled

Lopez McHugh has learned that transvaginal mesh devices, which are causing women extreme pain due to mesh erosion, extrusion, and failure, was approved by the FDA because they were similar another device on the market that has been recalled due to problems.

Yet this approval process is not limited to transvaginal mesh devices. A number of consumer advocacy groups have criticized the U.S. Food and Drug Administration’s 510(k) approval process, which allows medical devices to be approved without clinical trials based on their claimed similarity to devices already on the market.

Critics say the policy has a track record of allowing dangerous products to make it onto the market.

As a recent report in Scientific American points out, the supposed similarity between new products and previously approved ones can be flimsy at best. Even more absurd, products can be recalled as unsafe, yet still serve as the basis for a new product’s approval.

As an example, the Scientific American article mentions transvaginal mesh implants. Those devices are used to treat urinary incontinence and pelvic organ prolapse, a condition in which weakened muscles no longer provide adequate support for internal organs. As the report mentions, safer methods of treatment are available.

The FDA first approved the mesh implants in the late 1990’s, based on their similarity to existing devices used to treat internal hernias. But the new mesh implants were used for an entirely different part of the body. They also used a completely different method of implantation – through the vaginal wall rather than via abdominal surgery.

“In 1999, Boston Scientific voluntarily recalled its surgical mesh product called the ProteGen Sling, after numerous complaints of pain, infections, and injuries,” Scientific American writes. “Over a decade later, Johnson & Johnson faced hundreds of lawsuits over a surgical mesh device that was substantially similar (in fact had been cleared based on its similarity) to the ProteGen Sling.”

The most common reported problem is the vaginal mesh eroding and sticking through the walls of the bladder and vagina, causing severe pain.

Based on this information, Lopez McHugh is accepting vaginal mesh cases and attempting to get compensation and hopefully limit this harmful practice. If you experienced symptoms from transvaginal mesh, call us or fill out the form to the right for a free case evaluation.

See the report here: http://www.scientificamerican.com/article.cfm?id=four-medical-implants-escaped-fda-scrutiny