hernia mesh recall surgery

Surgical mesh in hernia operation

Hernia mesh is a medical device used in the implant surgery during hernia repair process. It helps to reinforce the weakened tissue and also prevent the recurrence of a hernia.

A brief understanding of the hernia meshes

Typically, any surgical mesh is made of synthetic materials or of animal tissues (pigs or cows). Synthetic meshes, which are commonly used in the recent decades, are woven of absorbable material, non-absorbable material or a combination of both these materials. This is because, medical studies have shown use of hernia mesh correlates with a decrease in the hernia recurrence rate. Unfortunately, some of the hernia meshes have caused an unreasonably high number of complications that led to recall of such products from the market.

As much as 90 percent of hernia repair surgeries in the U.S. use surgical mesh. Conventional hernia surgery stitches the tissues back together however, there have been some serious complications associated with them.

Complications that led to recall

Manufacturers such as Atrium, Ethicon, Bard, Medtronic has been some of the trusted names who actually concealed the probable complications associated with the meshes.

The major health complications include:

Fistula – The most serious concern with a defective hernia mesh is formation of fistula. is a late complication of prosthetic mesh repair that is caused mainly because of chronic erosion of bowel by the mesh particles placed in contact with the intestinal loops. Sudden discharge of pus or blood, irritation around the anal region, swelling, redness and tenderness in anus, pain associated with bowel movements and fever are some of the common symptoms.

hernia mesh recall surgery

Infection – to correct a faulty implanted surgical mesh, corrective surgeries are the only way out which is linked with causing infection. Also, the signs of infection may be clinically apparent many years after the implantation. The associated pain is not only because of using synthetic mesh but for the fact that the mesh is secured with stitches can become entangled with the nerves causing chronic pain.

Dental Problems- high rate of clients have complained about the teeth becoming weak, infected, chip off after the mesh infection.

Flu-Like Symptoms- nausea, chills, fever or vomiting are common complications post the hernia repair. For instance, the Atrium C-Qur hernia mesh is made with omega 3 fatty acid coating which often provokes an immune system response fighting the infection and the mesh.

What is recall and where are the surgical mesh placed?

A recall is basically a removal or correction of a medical device. The FDA designates a class corresponding to the degree of potential harm associated with the recall items. Basically, there are three types of classes of recalls such as:

  • Class I FDA Recall

This represents the highest level of concern and is explained as the particular “product will cause serious adverse health consequences or death.”

  • Class II FDA Recall

This suggests that the medical device “may cause temporary or medically reversible adverse health consequences”.

Most of the hernia surgical mesh recalls have been designated with this recall category.

  • Class III FDA Recall

This is when the medical device is not likely to cause adverse health consequences but has a certain level of health notice associated with it.

Are you completely in dark about how to go about the defective hernia repair products? Have you been victim to serious adverse health consequences with the mesh usage? The expert house of herniameshrecall.net will help to get the ideas in place and also let you know if the case is eligible for financial compensation. Visit http://herniameshrecall.net or dial 855-815-0586 to know more.

FDA ruling good for science?


FDA ruling good for science?


Which came first, the chicken or the egg? Well, in this case, was it the gynecologic surgeons who were too quick to adopt mesh in the O.R. or the FDA’s 510(k) approval process was too quick to allow mesh in gynecologic surgery. Who is to blame? You can read the full story here!

The problem now is that the mesh in some procedures (but not all) has a tendency to erode — wearing through the vaginal mucosa and exposing its rough and uncomfortable surface to the patient and her sexual partner — or constrict and scar, causing tightening and discomfort.

Some of these procedures have been stunning successes. Procedures that place mesh under the urethra (the tube that carries urine from the bladder to the outside) are generally quick, require minimal recovery, are safe and are proven to cure a particular type of incontinence. (This use of mesh is not part of the FDA warning, although this distinction may be lost on patients.)

But other mesh procedures, in which mesh is used to support one or more of the vaginal walls, have led to complications. The mesh used for these surgeries is essentially the same mesh used (successfully) by general surgeons to repair hernias and other abdominal wall defects.

Medicine cross pollinates from one field to another — we call it innovation. There is a long tradition of taking drugs and devices approved for one purpose and using them for another purpose. Once a device is FDA approved, physicians can (at their peril) use them for pretty much whatever they like. So it is with mesh. I believe that making it harder to get mesh approved for hernia repairs isn’t going to make it less likely to erode into women’s vaginas — it’s just going to slow down the process of getting discoveries into the clinics and into the O.R.

And the cowboy gynecologic surgeons? These are the innovators who brought about the successful mesh sling procedures that now cure 95 percent of women of incontinence in 30 minutes (when surgeries with 50 percent success rates used to take 5 hours in the O.R. and require weeks of recovery). Millions of women have benefited from the extraordinary era of innovation in gynecologic surgery over the past 15 years. Do we really want these surgeons to stop innovating?

Remember to check out the full story here!

A Few Questions Lingering About Implant Recalls


New Questions Raised on Implant Recalls


When implanted medical device products starts breaking, what is the basic human response from the creators of those devices?

One answer can be found in the case of a hernia repair device made by a subsidiary of C. R. Bard Inc. In late 2005, the company sent out a recall, urging doctors to stop using some versions of the product because a plastic component could break and cut through a patient’s internal organs and tissue.

At the time, Bard executives said they knew about some serious injuries potentially caused by the device, which is known as the Kugel patch. Since then, the Food and Drug Administration has received reports of more than 80 injuries and other problems possibly related to it, including several fatalities.

Bard officials said recently in a statement that they had not recalled the product sooner because complaints about failures were too few and unrelated to raise any alarms. The company also said that both it and the subsidiary, Davol Inc., had reacted responsibly.

But when F.D.A. officials inspected Davol in early 2006, they apparently found other reasons that company officials and the agency might not have been alerted earlier. For example, inspectors reported “discrepancies” and “inconsistencies” in how Davol tracked and analyzed device-related complaints.

And, in several instances, Davol also did not accurately report the possible severity of complaints to the agency, a copy of an inspection report obtained by The New York Times under the Freedom of Information Act shows.

You can read the full article here >> full story.