Regulatory Focus™ > News Articles > J&J Announces Planned Cessation of Vaginal Mesh Sales

J&J Announces Planned Cessation of Vaginal Mesh Sales

Posted 06 June 2012 | By Alexander Gaffney, RAC 

Johnson & Johnson subsidiary Ethicon announced on 5 June 2012 it will cease sales of a controversial line of vaginal mesh implant products after being hit with a series of lawsuits alleging the products cause internal bleeding.

Bloomberg Businessweek reports the company has requested approval from the US Food and Drug Administration (FDA) to end sales of the product within the next 120 days so consumers and doctors can find alternate suppliers or other treatment options. The implantable medical device is primarily used to treat vaginal prolapse, which can cause a range of related health problems. Hundreds of lawsuits allege the implants have become deformed over time, causing extreme discomfort and injuries.

The entire cessation of sales, which is not a recall of existing products, is set to be completed by the first quarter of 2013, said company spokesman Matthew Johnson. "We continue to have confidence in the safety and efficacy of these products," Johnson added.

An FDA investigation in March 2012 found Ethicon had marketed one of its four implant products, the Gynecare Prolift, for three years without regulatory approval. The company had reportedly reasoned the product was substantially equivalent to an already approved product known as the Gynecare Gynemesh. FDA "disagreed with this assertion," but no actions have yet been taken by the agency.

Other companies, including Endo Health Solutions and C.R. Bard are still planning to market the vaginal mesh implants.

Read more:

Bloomberg - J&J Tells Judge It Will Stop Sales of Vaginal Implants

Pharmalot - J&J To Halt Sales Of Vaginal Mesh Implants

Mass Device - J&J's decision to pull women's mesh is not a recall

WSJ - J&J to Stop Selling Surgical Mesh

House - Markey Statement on Johnson & Johnson Decision to Stop Marketing Transvaginal Mesh Medical Device

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