June 5, 2012
Johnson & Johnson Unit to Halt Urinary Implants
By KATIE THOMAS New York Times (FiDA blog bold)
Johnson & Johnson’s Ethicon division will stop selling four types of mesh implants used to treat urinary incontinence, the company announced in a letter to judges overseeing two large groups of lawsuits filed by women who claim the devices caused serious injury.
In a statement Tuesday, the company stressed that the move was not a recall, but was based on the products’ commercial viability “in light of changing market dynamics, and is not related to safety or efficacy.”
The announcement comes after years of controversy over the implants, which are used to treat incontinence caused by muscle weakening and a condition called pelvic organ prolapse, in which organs descend and press against the vaginal wall. The devices have been linked to serious injuries in women, including infections, pain and other complications. In 2008, the Food and Drug Administration warned that use of the implants was associated with complications but that the problems were rare. But between 2008 and 2010, the agency reported a fivefold increase in reports related to the use of the devices. In January, the F.D.A. ordered makers of the implants to study their risks in patients.
“This is very good news for women because it takes several products off the market that have harmed a lot of women,” said Diana Zuckerman, president of the National Research Center for Women and Families, a public health advocacy group. However, she said, “the bad news is that there are many other surgical meshes still on the market that are just as dangerous.”
Other device makers that also sell surgical mesh products include Boston Scientific, C. R. Bard and W. L. Gore & Associates. In a statement, a spokeswoman for Boston Scientific said the company believed that using such products “is and remains an important treatment option for patients.”
The four products Ethicon will discontinue are the Gynecare TVT Secur system, the Gynecare Prosima, the Gynecare Prolift and the Gynecare Prolift+M. Ethicon will stop selling the products over the next three to nine months, with a goal of ending sales worldwide by the first quarter of 2013. A spokesman for Ethicon declined to say how many women were implanted with the products.
Johnson & Johnson has undergone a series of product withdrawals and recalls in recent years, including the recall of artificial hips, contact lenses and other products, and the recent decision to end its line of drug-coated heart stents.