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Say Good-Bye to Norplant, and Hello to... Eleven years after first being sold in the United States, and two years after announcing that some lots sold after October 1999 may not be fully effective, Wyeth has decided not to continue selling Norplant in the US. A company spokesperson stated that the decision to no longer manufacture Norplant was due to a limited supply of some ingredients, but many in the public think that the decision was made to avoid future lawsuits. Lawsuits against Wyeth concerning Norplant were first filed starting in July of 1994 and have continued to be filed since. In August of 1999, Wyeth proposed making settlement offers to those plaintiffs with claims pending as of March 1, 1999. All federal suits against Wyeth are being consolidated and directed to a single judge in Beaumont, TX. Norplant’s days as an easy, effective, and convenient form of birth control are over, at least in the US. Norplant will continue to be produced and sold outside the US. But is it really the end? Jadelle, some call it Norplant II, was approved by the FDA in 1996 and licensed to Wyeth, but it never made it to market. Jadelle contains the same synthetic progestin as Norplant, but instead of six rods, Jadelle only consists of two rods. The rods for both Norplant and Jadelle are made of silicone rubber tubing, but the Jadelle rods are longer and thicker than Norplant’s. Jadelle was designed to be more comfortable and easier to insert and remove.
Wyeth has not stated that they will manufacture and sell Jadelle in the US, but they are considering it. Jadelle is currently available in several European countries, Finland, four East African countries, Indonesia, and Thailand. Wyeth also manufactures and sells Alesse, Lo/Orval, Orval, Ovrette, and Triphasil in the US. If you have considered sterilization in the past as a permanent form of birth control, then you should say hello to Essure. Recently the FDA’s Obstetrics and Gynecology Devices Panel voted 8 – 0, with one abstained vote, to recommend for approval Essure. Essure, developed by Conceptus, Inc., is a micro-insert that is soft and flexible and does not contain any hormones. Essure works as a permanent method of birth control by creating a block in the fallopian tubes, thereby keeping the sperm from meeting the egg. No surgery or general anesthesia is needed, and the procedure usually only takes 15 to 30 minutes to complete. Most women have been able to return to their regular activities in just one day, whereas with surgical tubal ligation the recovery time is from four to six days. Essure’s micro-insert is placed into the fallopian tubes through the cervix with a transcervical tubal access catheter. The micro-insert then encourages tissue growth around it, which effectively blocks the tubes. A woman should be able to leave and go home only 45 minutes after Essure has been inserted. An alternative method of birth control must be used for three months following the insertion of Essure during which time the device is allowed to build up tissue around it. Essure is currently available in Canada, many European countries, and Australia. No price for Essure has been set for the US market, but it currently sells elsewhere for $500 to $800. Tubal ligation cost approximately $1000 to $4000 depending on the area you live in, the length of your stay in the hospital, insurance coverage, doctor’s fees, and the anesthesiologist’s fee. The FDA is expected to make a final decision concerning the approval of Essure in early 2003. Although I have reservation about Wyeth proceeding with the manufacture and sale of Jadelle, which in my opinion is just a duplication of Norplant, it may be the best option for many women. Essure’s method of preventing pregnancy worries me, as I would be concerned about the possibility of an ectopic pregnancy. However, in their trials to date there have been no reports of pregnancy by users, so that is a good sign. Good-Bye Norplant! Hello to Jadelle and Essure, best wishes to you both!
Published
at Suite101.com's Birth Control Topic
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