The U.S. Food and Drug Administration has made great strides this year to shut down any and all products that were unsafe for consumers. On April 16, the FDA continued that quest, delivering orders to the manufacturers of all remaining surgical mesh products demanding a full transvaginal mesh shutdown of all products used to repair pelvic organ prolapse (POP). This included stopping the selling and distributing of any products in the U.S. effective immediately. In a press announcement made the same day, the FDA reaffirmed their position as defenders of the health of all consumers, and particularly women.
The Story Behind The Transvaginal Mesh Shutdown
Though the Transvaginal mesh shutdown is a recent and rather abrupt occurrence, surgical meshes are not a new technology. They have been a tool of surgeons as far back as the 1950s for repairing conditions like abdominal hernias. Beginning in 1970, gynecologists started to use surgical mesh for abdominal instances of POP but in the 1990s, they also began to use the meshes for the transvaginal repair of POP. In 2002, the first transvaginal mesh device was cleared for use as an FDA class II moderate-risk device. According to the FDA, 12.5% of women will have surgery to repair POP in her lifetime. Of these women, a not-insignificant number will have this procedure completed transvaginally with the use of surgical mesh
Suspicions about the safety of transvaginal meshes have existed since 2011 when an FDA safety communication implied risks to women using transvaginal mesh. In 2016, following a series of studies and follow-ups, the FDA reclassified transvaginal meshes as a class II, high risk, product. This was the last action taken before the transvaginal mesh shutdown was initiated. As a part of the reclassification process, the FDA required manufacturers like Boston Scientific and Coloplast would have to obtain a premarket approval application. This is the most stringent review pathway for any medical device.
Following the issuing of the class III designation, the FDA determined that manufacturers had not demonstrated a level of assured safety and effectiveness demanded of such devices. With this verdict declared, the FDA issued orders for the transvaginal mesh shutdown, preventing the sale of their products in the United States.
Dr. Jerry Shuren M.D., director of the FDA’s Center for Devices and Radiological health commented on the issue that “evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term.” Without an assurance of safety, the FDA pushed the order for the transvaginal mesh shutdown and began building its case for consumer safety.
For more information about transvaginal mesh and its complications, visit Parker Waichman’s transvaginal mesh page here.
Evidence For The Transvaginal Mesh Shutdown
The decision for the transvaginal mesh shutdown was not one reached overnight. The decision was carefully considered at a series of February 2019 panel meetings during which, the FDA brought on a number of experts to speak to the safety and efficacy of transvaginal meshes. After consultation and weighing of options, the panel of experts put forth the criteria that a transvaginal mesh could only be considered safe and effective if it is found to be superior to native tissue repair at the three year mark.
The FDA considered the proposition of the panel and eventually decided to accept their conclusions as the standard of safety. Unfortunately, because data that supported this standard was not provided by manufacturers in their premarket applications, the FDA did not approve the applications and the transvaginal mesh shutdown continued.
Though the transvaginal mesh shutdown means that these products can no longer be used or sold in patients in the future, transvaginal mesh manufacturers like Boston Scientific and Coloplast are still required to continue with follow-up studies of the subjects already enrolled in their 522 studies.
“Patient safety is our highest priority, and women must have access to safe medical devices that provide relief from symptoms and better management of their medical conditions. The FDA has committed to taking forceful new actions to enhance device safety and encourage innovations that lead to safer medical devices so that patients have access to safe and effective medical devices and the information they need to make informed decisions about their care” -Dr. Jerry Shuren M.D.
Additionally, transvaginal mesh companies will have 10 days to submit their plan to withdraw these products from the market. That deadline expires on Friday, April 26th.
The FDA also released guidelines for women who have already had transvaginal mesh used for the surgical repair of POP. The FDA advises these women to continue with annual and routine check-ups and follow-up care. If women are satisfied with their surgery and are not having complications or symptoms they are not required to take any extra actions.
However, the FDA has also released a series of symptoms for women with transvaginal meshes to be on the lookout for. These symptoms include:
- Persistent vaginal bleeding
- Persistent Vaginal discharge
- Pelvic or groin pain
- Pain with sex
If any woman with transvaginal mesh experiences these symptoms they should see a medical professional at once. Additionally, women should let their doctor know if they have surgical mesh if they plan to have another surgery or medical procedure. The FDA also notes that women who were planning to have mesh placed transvaginally for POP treatment should discuss alternative treatments with their doctor.
Fighting For Justice In The Wake of The Transvaginal Mesh Shutdown
Though the transvaginal mesh shutdown is a definitive victory for women moving forward, there are still many women who will likely suffer complications moving forward who were not properly informed about the risks and caveats of transvaginal mesh implantation. If you or a loved one have suffered complications from transvaginal mesh that you believed was safe, don’t wait to pursue compensation. Let Parker Waichman fight for you. Parker Waichman LLP’s experienced team of attorneys is ready to take cases and bring justice to people affected by the transvaginal mesh shutdown. Contact Parker Waichman today for a free consultation.
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