Product News and Recalls

Troubled Ethicon gets new product approved

According to a story on The Motley Fool, Johnson & Johnson-owned Ethicon announced in a press release that the U.S. Food and Drug Administration has granted approval for a tissue sealer called Enseal G 2.

The story characterizes it as “a bit of bright news” from Ethicon, noting that the company has initiated a number of recalls lately for items including hemorrhoidal staples and wound products.

And Ethicon is currently on trial in New Jersey state court over another product – transvaginal mesh implants, which are supposed to treat urinary incontinence and pelvic organ prolapse by shoring up weakened muscles.

Plaintiff Linda Gross of South Dakota alleges that she needed 18 operations to repair damage from the mesh, and had to quit her nursing job because of the chronic pain it caused her.

Gross’ is the first of about 1,800 lawsuits to go to trial, from plaintiffs who claim they suffered problems related to the implants including infection and organ perforation.

The Motley Fool story says Enseal G 2 is the first articulating sealer to allow surgeons to seal blood vessels up to 7 mm in diameter with a perpendicular approach.

According to the company, vessels sealed that way tend to be stronger than those sealed at an oblique angle. That’s supposed to minimize the risk of internal bleeding and complications after surgery.

If you have a vaginal mesh implant, you should consult with a doctor if you have any ongoing symptoms or health concerns. If you have significant injuries, you should also consult with a mesh lawyer to discuss your legal rights.

See the story here:

http://www.fool.com/investing/general/2013/02/05/ethicon-scores-fda-clearance-for-tissue-sealer.aspx