Surgical Mesh Complications Under FDA Review
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.
The Boston transvaginal mesh lawyers at Breakstone, White & Gluck have the skills, resources and expertise to handle cases involving defective medical devices. We have represented individuals in complex cases involving defective hip implants and surgical screws.