Surgery Mesh Recall

by Steve Fields on September 21st, 2012

Following the latest surgery mesh recall, women throughout the United States have continued to report a range of serious, life-altering vaginal mesh complications they suffered after undergoing mesh surgery. Some received their mesh implants transvaginally to correct stress urinary incontinence (SUI). Others did so to gain relief from pelvic organ prolapse (POP). In both cases, the device has been known to fail, causing injuries that are sometimes unresolvable.

As the number of vaginal mesh lawsuit claims continues to rise in the U.S., a group of Canadian women have come forward to speak about their own mesh injuries. Two of them have filed a transvaginal mesh class action lawsuit against Johnson & Johnson, one of the top manufacturers of these implants. In an interview with CTV News, they described the problems they have suffered, adding clarity to the controversy surrounding these devices.

Pain From Vaginal Mesh Complications Described As “Unbelievable”

Former nurse Carol Kouyoumjian told CTV News that she had undergone vaginal mesh surgery in 2006 to correct her urinary incontinence. She claims the implant failed to perform as expected. In addition, it caused severe, chronic pain to emanate through her legs, making it difficult for her to stand for long periods. She told the interviewer the pain she experienced was “absolutely unbelievable” and her legs “were literally vibrating.” It eventually caused her to lose her nursing job.

Diane McLaughlin also received a vaginal mesh implant in 2006 to treat incontinence. While her implant resolved the issue, she too described severe leg pain that would return repeatedly. In her words, “I never had this before, nothing so bad that you could just sit down and cry.”

Kouyoumjian and McLaughlin have since filed a multimillion dollar class action suit against Ethicon and Gynacare, the J&J subsidiaries that made their implants. Both women claim they were never informed of the risks associated with receiving vaginal mesh. They hope their lawsuit will result in mesh manufacturers being required to warn women of the dangers as well as the failure rate of the devices.

As an added unfortunate note, Kouyoumjian was advised by her physician to leave the failed implant in her body. Her body’s tissues had already grown into the device, making its removal difficult.

FDA Warns That Mesh Failure Causes Numerous Problems For Women

In the U.S., the FDA has issued two warnings about the potential risks of undergoing transvaginal mesh surgery. The first one was announced in 2008, after the agency received more than 1,000 reports of complications. The second warning was issued in 2011 following an additional 2,874 complaints.

The injuries described by women have included pelvic and vaginal pain, repeated infections, and persistent bleeding. For many victims, the pain is severe enough to motivate them to refrain from engaging in sexual intercourse.

These problems are often caused by erosion, one of the most common and serious transvaginal mesh complications reported to the FDA. The implants are designed to encourage tissue ingrowth. Unfortunately, the ingrowth fails to occur in many women. As a result, the mesh implants begin to move through the vaginal epithelium.

Some women also suffered mesh contraction, a circumstance in which the device shortens after installation. It is associated with severe, and sometimes incapacitating, pain.

Other side effects include vaginal scarring, recurrent prolapse, and problems related to the nerves that control the voluntary muscles. Sadly, these and other injuries have resulted in a significantly lower quality of life for many implant recipients.

Transvaginal Mesh Injuries Declared “Not Rare” By The FDA

The 2011 FDA warning indicated a change in the agency’s position regarding the rarity of the reported problems. It was noted that bladder sling problems were “not rare,” contrary to what the agency once believed. This was based on its receipt of an alarming number of adverse event reports between January 2008 and December 2010.

The number of women who have undergone vaginal mesh surgery is unknown. The FDA estimates that more than 200,000 women did so during 2010 alone. While there have been thousands of reported injuries involving these implants, many women have likely remained silent.

If you underwent transvaginal placement of surgical mesh, and have since experienced vaginal bleeding, infection, pain, and other side effects, you may be eligible to seek compensation. Contact an experienced vaginal mesh lawsuit lawyer to discuss your legal options and for the latest surgery mesh recall news.

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