510(K) Changes May Not Change the Problems with Surgical Transvaginal Mesh
Transvaginal mesh is used to treat stress urinary incontinence and/or pelvic organ prolapse, a condition where organs may drop down into, or even out of, the vagina. This transvaginal mesh surgery requires placing a permanent device (the surgical mesh) into the female pelvic cavity. Some females then suffer from complications related to the transvaginal surgical mesh – whether it be that the mesh erodes and protrudes into other organs, causes infections, or a host of other problems. The FDA recently concluded that the risks associated with transvaginal mesh used for pelvic organ prolapse outweigh the benefits of its use. So the questions remains – how did the transvaginal mesh get onto the market?
Manufacturers did not conduct a scientific review and lengthy testing process to get surgical transvaginal mesh onto the market. Nor were they required to conduct long term follow-up on patients to study the long term implications of the surgical transvaginal mesh. Instead the manufacturers relied on the Food and Drug Administration’s 510(k) process.
The 510(k) process is thirty-five years old and accounts for 90% of all device Food and Drug Administration applications each year. The 510(k) process allows a manufacturer to obtain clearance for a product by simply informing the Food and Drug Administration that the new device, such as surgical transvaginal mesh, was similar to an already approved device, such as the Boston Scientific ProteGen transvaginal surgical mesh. Then each new transvaginal mesh could obtain 510(k) clearance from the Food and Drug Administration by simply stating that the new surgical transvaginal mesh was similar to an already approved transvaginal mesh, even if that already approved transvaginal mesh was only cleared using the 510(k) process.
The Food and Drug Administration reported in January 2011 concern over using a recalled device as the basis for another device that is similar enough for the 510(k) process. This may be, in part, due to the U.S. Institute of Medicine report stating that approximately 29% of devices approved using the 510(k) process are no longer on the market. The Food and Drug Administration is considering multiple changes to the 510(k) system in the next year, including new stricter guidelines on what is considered a similar device.
510(k) changes may be too late for transvaginal mesh patients. In 1996, Boston Scientific Corp. won clearance for ProteGen, the first vaginally implanted surgical mesh designed to treat stress urinary incontinence. However, manufacturers relied on the creation of the ProteGen surgical mesh to obtain Food and Drug Administration approval for subsequent transvaginal mesh devices using this 510(k) process. In about 1999, Boston Scientific voluntarily pulled ProteGen transvaginal surgical mesh from the market due to safety complaints, which included complaints about erosion, painful sex and discomfort. However, when ProteGen surgical mesh was pulled from the market, the transvaginal mesh devices which were presented to the Food and Drug Administration as being similar to the ProteGen surgical mesh were not pulled off the market. In fact even after 1999, transvaginal mesh manufacturers, such as Johnson & Johnson, American Medical System and Covidien Plc, continued to get 510(k) approvals from the Food and Drug Administration for transvaginal mesh products whose design traced back to the ProteGen surgical mesh.
In September 2011, the Food and Drug Administration conducted hearings on the safety of transvaginal mesh used for pelvic organ prolapse as well as stress urinary incontinence. The panel recommended further studies to determine the risk benefit ratio for surgical mesh used in pelvic organ prolapse as well as pre-market studies for any further transvaginal meshes. The panel also recommended further studies on the mesh mini-sling used to treat stress urinary incontinence. However, panel recommendations made to the Food and Drug Administration typically take years to implement and for patients who already had transvaginal mesh implants, they may already being experiencing problems.