Recorded cases of transvaginal mesh patch recall

Following the overwhelming spate of demonstrations and calls on the FDA to issue an order to all the manufacturers of mesh implants to recall their products, many of the mesh manufacturers started doing this out of their discretion. The FDA never gave such orders. It only issued orders on tests, and proper information before it will be used. But when these orders came in form of order 555, many of the manufacturers of these products found it necessary to take the action of recalling their products even without an explicit order on that. However, most of these recalls came even year before the FDA delved into the matter, giving an impression that these firms had a prior idea about the dangers associated with their products. Below is the history of the recalls done so far?

The first mesh to be ever manufactured and used in the US is that produced by the Boston Scientific. Boston Scientifics’ ProtoGen came into the market a long time ago, before other transvaginal mesh joined it a year later. However, in 1999, the company out of their own volition recalled all their products in the market. At that time, there was no reason given for this recall. But own significant thing to note here is that this ProtoGen was the template that almost all the other meshes in the market followed. There is a rule in the laws of the FDA that when you manufacture a new product that has proper similarity with an existing product, you do not need to do another set of human testing before throwing this into the market. And since all these other meshes coming after the ProtoGen were developed similar to the ProtoGen, they were granted automatic access into the market without human testing. But when ProtoGen was recalled in 1999, questions started arising.

The next was the mesh produced by Mentor Corporation. This is perhaps the mesh that enjoyed the shortest life span in the market. This mesh which was named ObTape Vaginal Sling is a bladder sling that was introduced in 2003, but was recalled in 2006. The main reason why it was recalled by the manufacturers is because its users experienced a recurrent sort of vaginal erosion. This erosion was caused because it was manufactured with products that are deemed too dense. They never allowed the growth of tissues and capillaries, and were rejected by the body. However, it is good to note that before this product was recalled from the market, it has already been used by more than 35,000 women.

The next in the line is Ethicon, which was manufactured by Johnson and Johnson. This came in June 2012. They stopped selling all four of their Gyecare mesh products. But this is after they were involved in a lawsuit that was instituted by 600 women against their mesh. Because of this, they recalled Prolift Kit, Prolift + M Kit, TVT Secur, and Prosima Pelvic Floor Repair System Kit.

However, it is also good to know that Ethicon did not recall all its products. It continued the sale of Gynecare Gynemesh, but restricted this to be used for only abdominal implantations. Again, it never recalled the sold or implanted meshes. It only stopped selling new ones.

The last was that done by C.R. Bard in 2012. The product only got approval and came into the market in 2008, but was recalled in 2012 after they paid a compensation of $5.5 million one Mrs. Scott and $500,000 to the husband, because it ruined their sex life. The Avaulta Plus caused cuts in the woman’s colon.