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mdm8907
Posts:1
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| 01/10/2011 4:13 PM |
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Alloderm
This board has given me much information by way of education regarding different surgical procedures etc. and because of that I feel compelled to share with you information I recently found out regarding the product Alloderm. I only wish this information was given to me by my physician prior to my surgery. In order to make an intelligent choice between treatment options, a patient must be given the basic information on expected outcomes and possible risks. If there was a discussion between me and my physician regarding the risks and benefits of Alloderm it is my opinion I would have been in a better position to know if this was the most appropriate treatment plan for me. I have since learned that Nipple Sparing Mastectomy can be performed without the use of Alloderm.
There are both contraindications and adverse effects for this product which should be disclosed to you prior to your surgical procedure. Alloderm is contraindicated for use in patients who are sensitive to any of the antibiotics listed on the package or polysorbate 20. The list of antibiotics is not found on the package insert but rather on the front of the pouch containing the Alloderm. Also, contained on the front of the pouch is the serial number and lot number of the product. This information should be retained in your hospital medical record and usually is found under a document entitled “Implant Record.” The five different antibiotics found on the front of the pouch in trace amounts is 1. Gentimicin (please be aware if you have experienced any type of ringing/roaring sound in your ears) post-op surgery (i.e., heart beat sound) this is one side effect of this drug. Another side effect of Gentimicin is kidney disease such as acute kidney failure. 2. Cefoxitin, 3. Lincomcin, 4. Polymixin B. and 5. Vancomycin.
Adverse effects as per the package insert of Alloderm are as follows. Potential adverse effects which may result from placement of an implant or grafts include, but are not limited to the following: Wound or systemic infection, seroma, dehiscence, hypersensitive, allergic or other immune response; sloughing or failure of the graft and disease transmission. Also noted in the package insert is the statement “If any hair is visible, remove before insert.”
I question both LifeCell and the physician as to why this information is not made readily available to the patient especially the list of antibiotics prior to implant. How often does the patient have the opportunity to examine the front pouch of the Alloderm prior to surgery? My guess would be never.... The physician should be diligence in educating the patient in both potential contraindications and adverse effects of this product. A consumer should be able to know what the treatment options are and be able to question his/her doctor about these options. There is always more than one option and the benefits must be weighed by the patient. If the physician is not going to educate you then you need to be proactive and educate yourself. Have a list of questions available and please make sure you are comfortable with your doctors’ response. I question if this method of “doing business” by the physician has anything to do with his or her financial interest in the company. As an informed consumer do not be afraid to ask your doctor about his or her relationship with the pharmaceutical company. Ask if he or she is being paid any type of “consulting fees” and/or “discount” for the drug or surgical material he or she will be utilizing during your surgical procedure. The web site for LifeCell for your review of the package insert is www.lifecell.com.
If you have any questions regarding my issues, which occurred from the use of Alloderm please feel free to email me under separate cover at mdm8907@gmail.com. In order to response to your inquiry or comment please include your name and email address. Without this information I will unfortunately be unable to respond.
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