Prolift Transvaginal Mesh Discontinued in U.S. Still Sold Worldwide, Why?
by KATHY L. [Editors Note* Kathy L is not the real name of this author. She is involved in litigation and chooses to remain anonymous at this time. ]
January 29, 2013 ~ Last June, Johnson & Johnson subsidiary Ethicon informed a judge in West Virginia of its intention to discontinue sales of four vaginal mesh implant products.
Citing factors such as “the commercial viability of these products in competitive and declining worldwide markets, the complexities of the regulatory environments in which we operate, and the availability of other treatment options for women,” Ethicon spokesman Matthew Johnson stated that sales of the much-maligned vaginal mesh products would be ended worldwide on a region-by-region basis.
Now, almost eight months later, Mesh Medical Medical Device News Desk (MDND) has found that many of Ethicon’s products, including the Gynecare Prolift which has been the focus of thousands of lawsuits, is still being marketed and sold (here) in much of the world.
In fact, of all the countries in which Ethicon has a presence in Europe, Latin America, Africa and the Middle East, only France, Brazil and Italy’s Ethicon websites do not include the Gynecare Prolift product information.
The Prolift product information page states that utilization of the Prolift “demonstrated improvement with few complications,” as well as a “return of sexual function after surgery.” This is a stark contrast to the FDA’s findings in its July 2011 report (here) which stated that “mesh related complications are not rare.”
This is even more remarkable considering that just days ago Ethicon’s former Medical Director, Dr. Charlotte Owens, admitted that Ethicon’s own 2008 study (here) showed that after six months, 33.6% of women had post-surgery complications, including an erosion rate of 11.3%.
The Prolift Patient Product brochure (here) tells a very different tale, however, citing only a “small risk of the mesh material becoming exposed into the vaginal canal,” along with other “rare” complications such as injury to blood vessels of the pelvis, nerve damage, difficulty urinating, bladder and bowel injury.
In short, it appears that the location may have changed, but the rest has stayed the same.
When considering our sisters overseas undergoing life-altering surgeries that are nearly impossible to reverse and correct, it’s difficult to take comfort in Ethicon’s spokesman Matthew Johnson’s statement: “We continue to have confidence in the safety and efficacy of these products.”
We suspect that in his wingtips, Mr. Johnson’s toes were crossed.
[Editor’s Note* Mesh litigation concerning the Prolift continues in Superior Court New Jersey and is the focus of ongoing coverage by MDND Legal News here]