Product News and Recalls

Faulty implant reflects poorly on Johnson & Johnson

Investment blog Seeking Alpha points out that Johnson & Johnson’s decision to stop selling four types of vaginal mesh implants is the latest example of the company’s loose approach to product safety, and should be of concern to potential investors.

“While the New Jersey pharmaceutical giant stressed that the devices are safe, investors have had warning signs for years about J&J’s high risk of running into cross hairs with regulators,” the blog states.

Last week, Johnson & Johnson announced that it would stop selling the implants in response to mesh lawsuits from more than 600 women who claim the devices injured them.

Vaginal mesh implants are used to treat urinary incontinence and “pelvic organ prolapse,” which occurs when weakened muscles are unable to hold up internal organs. Alternative safe, effective treatments are available for both conditions, neither of which is debilitating or life-threatening.

Thousands of patients who received the devices have since complained that they eroded and shrank over time, causing debilitating pain and injuries including organ perforation.

In January, the FDA ordered Johnson & Johnson and 30 other makers of vaginal mesh implants to study organ damage and other health complications blamed on the devices. And in March, the FDA declared that Johnson & Johnson sold one of the implants, the Gynecare Prolift, for three years without proper regulatory approval.

In recent years, Seeking Alpha points out, Johnson & Johnson has had been the subject of many regulatory concerns.

Before 2009, the Johnson & Johnson unit McNeil Consumer Healthcare failed to investigate compliance problems at manufacturing facilities, according to the FDA. In 2010, the FDA issued a warning letter expressing serious concerns about the company’s control over the quality of its drugs. The FDA compliance staff later met with senior officials from McNeil and Johnson & Johnson, to warn the company representatives about a pattern of failing to report information and miscalculating risks, among other things.

After the FDA inspected the company in April 2010 and found manufacturing problems, including particles in liquid medications, McNeil announced a voluntary recall of over 136 million bottles of infants’ and children’s products.

Johnson & Johnson also recalled a line of all-metal hip implants from its DePuy Orthopaedics division in 2010, over widespread reports of the devices failing after a few years and leaving toxic metal debris in patients’ bodies.

You should consult with a doctor if you have any ongoing symptoms or health concerns from a Johnson & Johnson product. If you have significant injuries, you should also consult with a DePuy hip or transvaginal mesh lawyer to discuss your legal rights.

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