FDA Warnings



Reports of serious complications from transvaginal mesh devices have resulted in safety alerts from the FDA. Here are some of the warnings:
In October 2008, the FDA issued a safety alert to surgeons about the risks connected to transvaginal mesh devices. The warning was based on more than 1,000 reports of complications, which the agency received between 2005 and 2007. In this warning, the FDA indicated that potential contributing factors to mesh device complications may include general patient health, mesh material, surgical and additional procedures during the same operation (e.g., hysterectomy) and estrogen levels.

In July 2011, the FDA identified the most common problems resulting from mesh devices. They include mesh erosion through the vagina, extrusion or exposure. Pain, infection, bleeding and painful sex also occur frequently as well as organ perforation and urinary dysfunction. Other serious complications are mesh shrinkage, which can create intense pain, scarring, vaginal shortening and sexual dysfunction. Recurrence of POP and neuromuscular issues are other factors often leading to multiple surgeries, which do not always fix the issues. In this report, the FDA also stated that transvaginal mesh implantation does not deliver improved clinical results than traditional non-mesh procedures and recommended safer alternatives.

The FDA also provided the following guidelines for surgeons:

Undergo special training for each mesh implantation, and consider the risks.

Be vigilant regarding complications, particularly erosion and infection..

Monitor problems related to the procedure including bowel, bladder and blood vessel perforations.

Let patients know that the mesh implantation is permanent and that some issues may lead to revision surgery, which may not correct the problem.

In addition, the agency has required mesh manufacturers to complete safety assessments of the mesh products.
In 2014, the FDA submitted two proposals to reclassify mesh products as a Class III device, necessitating strict testing before products sales. In 2016, the new status was approved.

Transvaginal Mesh Device Recalls

To date, the FDA has not issued a recall of mesh devices despite all of the warnings. However, after the safety alerts, several manufacturers have recalled some of their own products and stopped selling others. Here are some of the details:

In 1999, Boston Scientific recalled its ProtoGen mesh implant.

In 2006, Mentor Corporation replaced its ObTape sling with a new product..

In 2012, Johnson & Johnson’s Ethicon subsidiary stopped selling four different Gynecare mesh products and changed the information on labels for other devices.

In 2012, C.R. Bard ended production of the Avaulta Plus device, which was approved in 2008.

In August 2011, Public Citizen demanded a recall of all mesh products with non-absorbable synthetic material. On behalf of consumers, the group stated that the FDA has an obligation to remove these products from the marketplace because of the risk of injuries.

Contact Transvaginal Mesh Lawyers for a Free, Confidential Legal Consultation

Based on the FDA's warnings, the manufacturers' own recalls of mesh devices and a consumer group's outcries, these products clearly present a high risk of complications. If you are a woman who suffered the devastating consequences of using a mesh product, you may be entitled to compensation. Contact transvaginal mesh lawyers for a free, confidential consultation.

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