Articles Tagged with “Transvaginal Mesh Surgery”

A Food and Drug Administration (FDA) panel will begin discussing the safety and effectiveness of urogynecologic mesh products Wednesday. Surgical mesh is a medical device that is implanted into a woman during transvaginal mesh surgery.

On July 13, the FDA issued an update on a 2008 public health notification reporting complications from surgical mesh used in transvaginal mesh surgery are not rare. It also reported it was not clear that transvaginal mesh surgery is more effective than non-mesh repair of POP.

Transvaginal mesh surgery is used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). POP occurs when the tissues that hold the pelvic organs become weakened or stretched. SUI is a bladder condition.

In its July 13 update, the FDA reported it had received more than 3,800 reports of complications about transvaginal mesh surgery between 2005 and 2010. It urged surgeons and physicians to consider other options before performing the surgery.

Possible transvaginal mesh complications include internal mesh erosion, pain during intercourse, infection, bleeding, organ perforation and urinary problems.

The FDA warned that surgical mesh is a permanent implant that may require several surgeries to correct. Full removal of surgical mesh may not be possible.

The FDA will convene its Obstetrics-Gynecology Devices Panel of the Medical Device Advisory Committee on Wednesday and Thursday (September 8 and 9, 2011). The panel will discuss the safety of transvaginal surgical mesh for POP and SUI.

One consumer advocacy group has called for the FDA to recall surgical mesh. Public Citizen of Washington, D.C. – the organization founded by Ralph Nader – has also asked the FDA to reclassify surgical mesh so that future releases must undergo a more stringent approval process.

Other medical professionals support the procedure. A nationwide group of 600 pelvic surgeons has submitted a letter to the FDA challenging findings involving surgical mesh injuries.

Nine companies manufacture surgical mesh, including Boston Scientific and Johnson & Johnson.

If you have been injured during transvaginal mesh surgery, it is important to contact an experienced Boston medical device recall lawyer who can protect your interests as the FDA conducts its review. An attorney can advocate for you and ensure you obtain compensation for your injuries.

For a free legal consultation, contact the Boston lawyers at Breakstone, White & Gluck in Boston at 1-800-379-1244 or use our contact form.
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Following thousands of reports about serious injuries among women, a Food and Drug Administration (FDA) panel will begin examining the safety of surgical mesh on Sept. 8 and 9.

Surgical mesh is implanted during transvaginal mesh surgery, the treatment for Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). The procedure is performed to repair weak or stretched vaginal tissue, often after childbirth.

The panel’s review comes almost two months after the FDA’s July 13 public safety advisory on surgical mesh and as special interests step into the debate about a possible surgical mesh recall.

In the July 13 advisory, the FDA said transvaginal POP repair with mesh has no advantage over traditional non-mesh repair. The FDA’s finding was based on a review of scientific literature published between 2006 and 2011.

Between 2005 and 2010, more than 3,800 women had reported complications and injuries following transvaginal mesh surgery, according to the FDA.

The most prevalent complaint was mesh erosion within the body, but other injuries included bleeding, pain during sexual intercourse, organ perforation, vaginal scarring, muscular and emotional problems. Remedies include corrective surgery, hospitalization and intensive follow-up medical treatment.

On August 25, 2011, Public Citizen, a Washington D.C.-based consumer advocacy group, called for a recall of all non-absorbable synthetic material used in transvaginal mesh surgery. It also wants a reclassification of the approval process for new surgical mesh products.

The same day, a coalition of 600 pelvic surgeons submitted the FDA a letter challenging its findings about the risk for complications during transvaginal mesh surgery. The letter was obtained by the CommonHealth medical website. Among their challenges, the surgeons argued mesh erosion is not a major complication.

In 2010, approximately 300,000 women in the U.S. had surgery to repair POP, including 75,000 of whom had surgical mesh transvaginally implanted, according to the FDA.

Nine companies manufacture transvaginal mesh products, including Boston Scientific and Johnson & Johnson. Bloomberg News reported one recommendation from the FDA staff administration would require the manufacturers to submit additional safety data to regulators.

The FDA cleared 85 mesh devices to treat pelvic organ prolapse from 1992 to 2010.
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Several weeks after the Food and Drug Administration (FDA) issued a public notice about the dangers of transvaginal mesh surgery, a consumer advocacy group is calling for the recall of all surgical mesh products used in the procedure.

Public Citizen of Washington D.C. petitioned the FDA on August 25, calling for the recall of all surgical mesh products made of non-absorbable synthetic material used in transvaginal mesh surgery. This type of mesh is used during transvaginal surgery to repair pelvic organ prolapse (POP) and Stress Urinary Incontinence (SUI). POP occurs when organs bulge into the vaginal and bladder areas. SUI is a loss of bladder control.

In 2010, approximately 300,000 women in the U.S. had surgery to repair POP, including 75,000 of whom had surgical mesh transvaginally implanted, according to the FDA.