Helpful Links

Locate a hernia specialist from the Americas Hernia Society
here

WebMD basic information on hernia here

FDA on hernia mesh here

Wall Street Journal article on possible issues with hernia repair
here

Mayo Clinic information on umbilical hernia
here

UK health information on hernia
here

Medicine net on hernia
here

 


Legal note:

Insightra medical does not endorse or imply it agrees with the information contained in these external sites. The above links are placed as supplemental help for patients wishing to understand more about hernia repair. By clicking on the links, patients accept that following these links takes them to external sites.

 

 

 

ventral patient

What is a ventral hernia?

Ventral hernia is an abnormal outpouching through the wall of the abdomen. It is a common problem that affects both men and women, but incisional hernias affect twice as many women as men.

Ventral hernias come by different names and appear for different reasons. But they may be called umbilical hernias (around the belly button), Epigastric hernias (up near the ribs), stomal hernias (around stomas), or the most common, incisional hernia (anywhere through a previous surgery scar)

 

The hernia can be a small lump that is asymptomatic (causes no pain or discomfort) or it can be painful and troublesome, especially during physical activity. The cause of ventral hernias depends on the type of hernia it is. Incisional hernias (15%-20% of all hernias) are usually caused because something did not heal properly following surgery. This could be for many reasons. The patient had a weak kind of tissue (a collagen disorder) or they had other problems that affected healing such as diabetes. Other types of hernia such as epigastric and umbilical (10% of all hernias) can be caused through a stress event causing a small rupture of the muscles. Or they could have been there as weakness since birth (congenital).

The hernia is caused by the contents of the abdomen (such as the bowels) pushing through a weakness or hole that is not normally there in the abdominal wall. It forms a pouch that can be felt or seen. Sometimes they are small and sometimes they can be very large.


Do I need to see a doctor?

Yes. If you suspect you have any type of ventral hernia, it is advisable to see a physician as soon as possible so they can make an assessment on your condition.

 

Do I need surgery?

Not everyone with a ventral wall hernia needs surgery. Some hernias, if small and not troublesome can follow what is called "watch and wait". Your physician will be able to examine you and determine if you require surgery or not. However the majority of ventral hernias may require a surgical intervention.

 

What are the surgical options?

Today there are a wide variety of surgical options to treat ventral hernia. The options offered will depend on your needs and wishes, as well as the clinical condition of your hernia, your physical health and the procedures offered by the surgeon. Generally ventral hernia operations fall into two categories:

Keyhole or Laparoscopic
This is a method where the surgeon will not make an incision (cut) in your abdomen above the hernia. Instead they will put in small keyholes (trocars) into your abdomen, usually three or four. Then with a video camera and long instruments they will repair the hernia from the inside of the abdomen. The procedure can take about one hour or more.

Open
This is still the most common method. The surgeon will make an incision (cut) above the hernia in your abdomen. They will then work from the outside-in to repair the hernia. Closing the incision with sutures or skin glue after the operation.

What's the difference?
Both methods are well proven, and both have been shown to offer different benefits and risks.
Keyhole surgery is considered more technically challenging, and carries risks associated with keyhole surgery. It is nearly always carried out under general anaesthesia in a specialist laparoscopic center. The advantages are generally seen to be a faster return to work / normal activity after the surgery. It is considered an excellent option for patients with smaller, less complex ventral hernias, or undergoing a revision surgery for a ventral hernia that has come back.
Open surgery is more frequently carried out in larger, complex ventral hernias as it is technically challenging to place large hernia implants. It does not carry any of the risks associated with keyhole surgery but does carry risks associated with major abdominal incisions. It is sometimes more painful, but modern pain management techniques can help greatly.

You should ask your doctor about both options - and which is more suited to your clinical condition and to your personal needs.

 

What are meshes and are they safe?

The most common option today (either keyhole or open) is to use something called a "hernia mesh" or "hernia implant".

Historically to fix the hernia, the surgeon would make an incision, then dissect (free up) the hernia pouch and return it to the abdomen. They would then close the hole in the abdominal wall by only using sutures to stitch the hole together. The problem with this was that it put those tissues under a lot of tension and this would cause a lot of pain and discomfort to patients. Also in many patients the tissue being sewn together was not very strong so the hernia would come back (recurrence). This led surgeons to think about "reinforcing" the hernia area with a patch.

The advantages of placing a patch were the reduction in tension (sometimes called a tension free repair) and the patch would help to reinforce the abdomens natural tissues - like putting a patch on the elbow of a sweater.

This patch was often made out of a synthetic mesh material - this patch is the hernia mesh.

Today there are also non synthetic materials called biologics. They are made from very special tissues (either animal or human) that have been recovered and treated to be inert and safe. They are often used when the hernia is very complex, such as infected hernias.

The mesh can be placed either above the hernia, below the hernia or both. In a keyhole repair the mesh is generally placed below the hernia hole (underlay), in open it can be placed above (onlay), or below (sublay). The mesh is generally held in place with sutures (stitches) or there are new devices that place small absorbable tacks that hold the mesh in place while the body grows natural tissue over it.

Are they safe?
Anything that is placed into the body will have benefits and risks - and every patient will react differently. Meshes or hernia implants are no different. The benefits are that they reduce the tension on the repair and reinforce the abdominal wall. The clinical literature shows clear benefits of reducing the failure rate (recurrence).

However they do carry risks that are different to not using a mesh. Synthetic meshes have a higher risk of becoming infected. They also carry a risk of a foreign body reaction, which can include pain, fever, discomfort, sensation of the foreign body, rejection of the foreign body and other side effects your doctor can discuss with you in detail - but make sure before deciding to have a mesh or implant that you discuss fully with your doctor.

 

What does the FDA say?

Please read this advice from the FDA and consult fully with your doctor.

Food & Drug Administration, The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. The core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.

Please follow this link to the FDA

Information on Surgical Mesh for Hernia Repairs
FDA wants to inform you about complications that may occur with the surgical mesh that is sometimes used to repair hernias, and to provide you with questions you may want to ask your surgeon before having this procedure. This is part of our commitment to keep the public informed about the medical products we regulate.

Hundreds of thousands of hernia repair operations are performed each year both with and without surgical mesh, and patients generally recover quickly and do well after surgery.

However, FDA has received reports of complications associated with the mesh. The complications include adverse reactions to the mesh, adhesions (when the loops of the intestines adhere to each other or the mesh), and injuries to nearby organs, nerves or blood vessels . Other complications of hernia repair can occur with or without the mesh, including infection, chronic pain and hernia recurrence.

Most of the complications reported to us so far have been associated with mesh products that have been recalled and are no longer on the market. For further information on the recalled products, please visit the FDA Medical Device Recall website.

We are continuing to analyze and evaluate incoming reports of adverse events, and are speaking with patients, surgeons and researchers. We will inform the public as new information becomes available.

Talking to your doctor
Before having a hernia operation, be sure to let the surgeon know if you’ve had a past reaction to materials used in surgical mesh or sutures, such as polypropylene.

There are also certain questions you should consider asking your surgeon:

What are the pros and cons of using surgical mesh in my particular case?
If surgical mesh will be used, is there special patient information that comes with the product, and can I have a copy?
If surgical mesh will be used, what’s been your experience with this particular product, and with treating potential mesh complications?
What can I expect to feel after surgery and for how long?

Reporting complications to the FDA
In order to help FDA learn more about possible problems with surgical mesh, it’s important that both physicians and patients report complications that may be associated with this product.

You can report any problems to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

Online : MedWatch Online Voluntary Reporting Form (3500)
Regular Mail : use postage-paid FDA form 3500 available at: MedWatch Forms
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
FAX: 1-800-FDA-0178

 

What are the common problems with hernia surgery?

In general ventral hernia surgery is safe and is a frequently performed procedure. However like all surgery it carries certain risks, that you should discuss with your physician. The risks will vary depending on any previous surgery, your weight, if you have a diabetes, cardiac problems or other issues. Again, you should discuss all of these factors with your physician to understand the risks.

There are risks associated to all surgery, such as complications with anesthesia, infection, bleeding etc.
But hernia surgery has its own particular problems that you should be aware of.

The repair of your hernia may not be definite, that means the same hernia could come back (recurrence) or a new hernia could form in another area of the abdomen (a new hernia). It is not easy to say what % of patients have a recurrence as it depends greatly on the size of the hernia, the location of the hernia, how many previous surgeries and many other factors. You should ask your doctor about recurrence in your particular type of hernia. However you should be aware this could mean you require a second operation to fix the hernia again.

Other problems in ventral hernia repair can be accumulation of fluid (seroma), or accumulations of blood (hematoma) especially when large meshes are placed. Generally these problems are transient and can be resolved without second operations.

Post operative pain and or discomfort is a common problem associated with ventral hernia repair procedures. In the early days after your surgery this can be caused by the incision (in an open repair) or by the actual operation itself, especially if it was a large hernia. This is an "acute" pain generally associated to the fact you've been operated on. But your doctor can help by prescribing pain killers to take in the weeks after surgery. The level of pain is very patient dependent.

Of more concern is long term pain and discomfort. There are many reasons this can happen. The nerves in the abdomen can be touched, inflamed or damaged during surgery. Your surgeon will take every care to avoid those nerves, but each patient has them in different places so avoidance cannot be guaranteed. Long lasting nerve pain will need to be treated by your doctor and could include second procedure to treat the nerves. If the nerves are "entrapped" in any implant or mesh, then the mesh may need to be surgically removed or replaced. You should discuss this with your doctor, especially any procedure to remove the mesh.

In some patients the mesh can have a "shrinkage" reaction. This is generally where the natural scarring that occurs in the mesh becomes aggressive, and causes a contraction of the mesh. This can cause pain or discomfort or even a sensation of feeling the mesh. It is a rare complication but you should discuss this risk before deciding to have a mesh placed. Ask your doctor about removing the mesh should such a problem arise.

Although the above complication and problems are rare, it is vital before deciding to have a permanent implant, to weigh the risks and benefits and have a direct and clear conversation with your physician about all the options.

What is the Freedom Ventral Hernia System?

Please see page 2