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Wed, 03/25/2009 - 21:16 — admin

Talk to a Doctor About Adhesions

Since adhesions can recur once you have them, it's important to talk to your doctor about what can be done to reduce the risk of them forming in the first place. Talk to your doctor today about whether GYNECARE INTERCEED® may be right for you.

Get the conversation started today. Based on your condition, there are questions you might want to ask your doctor or surgeon.

The following questions are designed to help you find out more information about your particular condition and the kinds of treatment that may be right for you. The more informed you are, the more comfortable you'll be with the decision you, your family and your doctor make together.

  1. Will you be doing the actual surgery? (If not, you might want to meet the doctor who will.)
  2. How should I prepare for the procedure?
  3. What are the steps involved in the procedure?
  4. What risks are involved in having the procedure?
  5. is it possible for adhesions to form as a result of this procedure?
  6. What will be done during the procedure to help reduce the risk of adhesions from forming?
  7. Do you plan to use an adhesion barrier, like GYNECARE INTERCEED®, to reduce the risk of abnormal internal scarring after the procedure?
  8. Are there symptoms of adhesions that I should watch for as I recover from surgery? What else should I watch out for as my incision heals?
  9. What steps can be taken to reduce or eliminate the risk of infection?
  10. Is a topical skin adhesive an available option for the incision?
  11. Are there any steps we can take to speed up my recovery?

Remember to learn all you can, and ask questions about the issues that are most important to you. This is the best way to feel confident that you are making the best decision possible. For added support, consider bringing a friend who can ask the questions you feel embarrassed about or may forget to ask.

Click here to print these questions to ask your doctor (4 MB)





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Risk Information

GYNECARE INTERCEED®
ABSORBABLE ADHESION BARRIER PATIENT EPI

INDICATIONS: GYNECARE INTERCEED® Absorbable Adhesion Barrier is indicated as an adjuvant in open (laparotomy) gynecologic pelvic surgery for reducing the incidence of postoperative pelvic adhesions after meticulous hemostasis is achieved consistent with microsurgical principles.

CONTRAINDICATIONS: The use of GYNECARE INTERCEED® Absorbable Adhesion Barrier is contraindicated in the presence of frank infection. GYNECARE INTERCEED® is not indicated as a hemostatic agent. Appropriate means of achieving hemostasis must be employed.

WARNINGS: The safety and effectiveness of GYNECARE INTERCEED® in laparoscopic surgery or any procedures other than open (laparotomy) gynecologic microsurgical procedures have not been established.

Postoperative adhesions may be induced by GYNECARE INTERCEED® application if adjacent tissues (eg, ovary and tube) and structures are coapted or conjoined by the device, or if GYNECARE INTERCEED® is folded, wadded or layered. Postoperative adhesions may occur in the presence of GYNECARE INTERCEED® if meticulous hemostasis is not achieved prior to application. As with all foreign substances, GYNECARE INTERCEED® should not be placed in a contaminated surgical site.

PRECAUTIONS: Use only a single layer of GYNECARE INTERCEED®, since multiple layers of packing or folding will not enhance the adhesion barrier characteristics and may interfere with the absorption rate of
GYNECARE INTERCEED®. Care should be exercised in applying GYNECARE INTERCEED® to a pelvic organ not to constrict or restrict it. If the product comes in contact with blood prior to completing the procedure, it should be discarded, as fibrin deposition cannot be removed by irrigation and may promote adhesions formation. Ectopic pregnancies have been associated with fertility surgery of the female reproductive tract. No data exist to establish the effect, if any, of GYNECARE INTERCEED® on the occurrence of ectopic pregnancies. No adequate studies have been conducted in women who have become pregnant within the first month after exposure to GYNECARE INTERCEED®. No teratogenic studies have been performed. Therefore, avoidance of conception should be considered during the first complete menstrual cycle after use of GYNECARE INTERCEED®. The safety and effectiveness of using
GYNECARE INTERCEED® in combination with other adhesion prevention treatments have not been clinically established. GYNECARE INTERCEED® is supplied sterile. As the material is not compatible with autoclaving or ethylene oxide sterilization, GYNECARE INTERCEED® must not be resterilized. Foreign body reactions may occur in some patients. Interactions may occur between GYNECARE INTERCEED® and some drugs used at the surgical site. Pathologists examining sites of GYNECARE INTERCEED® placement should be made aware of its usage and of the normal cellular response to GYNECARE INTERCEED® ‘to facilitate proper evaluation of specimens'.

ADVERSE REACTIONS: The type and frequency of adverse events reported are consistent with events typically seen following surgery. Postsurgical adhesions may occur in the presence of GYNECARE INTERCEED®.

For more information, please consult your doctor or call 1-888-GYNECARE to speak with a nurse

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