November 17, 2006

FDA Approval of Silicone Breast Implants Reflects the Times

Years after thousands of women participated in the Breast Implant class action, with injuries that ran the gamut from rupture leading to re-implant surgery to severe immune disease, the FDA has now essentially white washed the product for use by women as they choose. It has now approved the use of silicone for cosmetic breast enhancement surgeries.

Many women will now have the choice to use silicone or saline for their breast enhancements. Previously, the FDA banned the use of silicone for cosmetic breast enhancements because of the health risks associated with possible leaks. Today, the FDA takes the position that they are “reasonably assured” that silicone breast implants are safe. My experience concerning women injured by these implants both from my clients and as viewed in the seminars I have attended is very much at odds with a clean bill of health for this product.

Women now considering silicone implants will experience ruptures just as they did when these implants were previously marketed. My experience is that the silicone can become systemic, with lumps of the stuff appearing in places and times that it is not expected. Certainly women choosing this implant should educate themselves about the risks involved in choosing silicone implants. They should also consider the necessary and costly medical treatment that goes hand in hand with the product. For example, in the event that a silicone breast implant ruptures, the woman may not experience any immediate symptoms. It is possible that the rupture is initially detected only on MRI examination. These are now important studies in detecting ruptures and a decision to choose silicone breast implants will subject the woman to a lifetime of MRI examinations. The FDA states that the first MRI examination is to be conducted three years after the surgery. In addition, the FDA recommends an MRI be conducted every two years thereafter. Not only will the cost of MRI’s exceed the cost of the initial breast enhancement surgery, but women may have to pay these costs out of their own pockets. Obviously, as has been the case previously, ruptured implants portend additional surgeries with additional scarring and potential disfigurement.

Furthermore, women must be aware of the risks of physical injury involved with possible ruptures. Women may be subjected to multiple operations, hardening of the area around the implant, changes in nipple and breast sensation, and as discussed above, rupture with or without symptoms and possible migration of the silicone in the woman’s body.

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August 14, 2006

Gastric Bypass Surgery Risks Include Internal Hernia

I just finished a wrongful death case where a 30 year old woman died of one severe complication of gastric bypass surgery. She experienced what is termed an internal hernia, where the small intestine migrates through a hole intentionally made by most surgeons performing a Roux enY procedure using a laparoscope. There are many complications of gastric bypass surgery including gallstones, leakage of stomach contents into abdomen, nutritional deficiencies and more. See WebMD.
Internal hernia is not an uncommon complication of gastric bypass. It can be difficult to diagnose and disastrous if it remains undiagnosed. The danger is that the migrated intestine can twist on itself much like a garden hose can kink and cut off blood flow leading to inadequate or no blood flow and death of tissue. The hernia with migration of intestine is not necessarily acutely painful if it has not twisted on itself. One may simply feel generalized discomfort and abdominal pain that is not severe. The pain and associated problems can wax and wane because the intestine may migrate back through the hole to return to its original position. A patient may experience diarrhea and/or nausea or vomiting and be unable to eat. In some cases this can be confused with dumping syndrome by the treating physician. Often the pain is upper abdominal because the mesocolon hole that is made during surgery is in that location, above the umbilicus (belly button). The best test to diagnose the internal hernia is the CT scan, although a negative CT will not rule out the problem.

If portions of the 25 or more foot long intestine migrate through the hole in the mesocolon made by the laparoscope, sometimes the intestine can be trapped in the hole--it can get in but is unable to get out. If incarceration or twisting occurs the patient will likely experience severe pain requiring immediate treatment, probably to include surgery. Sometimes the symptoms can include those early symptoms of sepsis, either low or high temperatures, an increased respiration rate and/or increased heart rate. Careful monitoring of a patient with this complication in the differential diagnosis is essential and care must be taken to insure the patient does not descend into septic shock.

Actually, any patient with suspected internal hernia should have that complication ruled in or out without delay. Timing can be a life or death decision since no one knows when the migrated intestine can become twisted, incarcerated and ischemic.

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