Minggu, 17 November 2013

Two Mesh Manufacturers, One Bad Day

Two Mesh Manufacturers, One Bad Day

Two mesh implant manufacturers, Endo Health Solutions and Johnson & Johnson (J & J), seemed be having a bad day last Thursday. In Atlantic City, a jury has ordered J & J to pay the sum of $ 7.8 million to an ex-hospice nurse. This amount is to cover for punitive damages for various pains and sufferings that she has endured for using Ethicon’s vaginal mesh implant. J & J is the mother company of Ethicon. 

This verdict came after a $ 3.35 million award has been delivered by the court on Monday for compensatory damages. For its part, J & J stipulated that it would appeal.

Endo Health’s Big Loss on the Same Thursday

Meanwhile, Endo Health of Malvern went public on Thursday announcing that it has incurred big losses. This is due mainly to the $ 640 million write down placed on its device division, American Medical Systems (AMS).

AMS as a business entity is focused mainly on pelvic health problems which includes among others vaginal mesh implants. On the 11th of April, 2011, Endo announced its plans to acquire AMS ,debt including, even if it has to spend $ 2.9 billion.

Endo advised on its website that 34 million women suffer from pelvic organ prolapse or POP. This is the condition wherein internal organs near the pelvis of a woman sag due to the weakening of the muscles. This usually happens years after a woman has given birth. Vaginal mesh implants were designed to treat POP.

Both Mesh Manufacturers Face Hundreds of Lawsuits

In 2005, Ethicon, J & J’s subsidiary, introduced to the US market its Gynecare Prolift implant. However, the product was ultimately withdrawn from the market by 2012 amid various reports of complications and compounding lawsuits.

To note, in October of 2008 the FDA has issued public warnings on the use of vaginal mesh implants. However, this public concern was later ramped up by the agency by June of 2011, a few months after Endo acquired AMS. Later, in January of 2012, the FDA finally rolled out orders for post-marketing surveys on the use of vaginal mesh implants. This sounded like a slap on the wrist for most mesh manufacturers.

In the state courts of New Jersey alone, J & J is facing over 1,800 lawsuits over the transvaginal mesh. To date, the number of lawsuits faced by various manufacturers over the mesh has reached tens of thousands. As of last fall, Endo faced over 2,900 mesh lawsuits.

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