Philadelphia Products Liability Attorneys: Mirena® Intrauterine Device Causing Significant Injury to Women
February 13, 2013
The Philadelphia products liability lawyers at Galfand Berger are warning the public about an especially alarming product that can cause serious injuries to women consumers. The device is the Mirena intrauterine device (IUD), which is a contraceptive device used primarily for long-term birth control to prevent pregnancy. Sadly, there has recently been a number of cases in which users have reported that this medical device has lead to serious health consequences including a punctured or perforated uterus, and cases in which the device has migrated to other parts of the body. The personal injury law firm of Galfand Berger is dedicated to protecting the rights of victims injured by defective medical devices and is currently investigating potential Mirena lawsuits for clients who have used and been injured by the Mirena IUD.
Mirena Intrauterine Device Manufactured by Bayer HealthCare Pharmaceuticals
The Mirena IUD is manufactured by Bayer HealthCare Pharmaceuticals and was first approved for use in the year 2000 by the Food and Drug Administration (FDA). It was originally approved as a form of contraception, but later it also became useful as a treatment for women who developed heavy menstrual bleeding after giving birth. It is recommended to women who have had at least one child and are involved in a monogamous relationship. There are more than 2 million women in the United States who are using this potentially dangerous medical device.
The Mirena IUD is a small t-shaped plastic contraceptive device that is implanted into the uterus of woman by a qualified medical provider. The device slowly releases a hormone called levonorgestrel continuously over a 5-year time frame as a means to prevent pregnancy. Levonorgestrel causes changes in a woman’s cervical mucus as well as the uterine lining. These changes make it difficult for a male’s sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.
Women may experience side effects while the IUD is in place. The side effects that are most commonly associated with Mirena include amenorrhea, spotting, back pain, lower abdominal pain, headaches, nausea, acne, breast tenderness, ovarian cysts, mood swings and depression. Many times these side effects will go away or subside after the first couple of weeks or months.
Mirena Medical Device May Lead to Serious Health Complications
There are some particularly troubling and dangerous side effects that are now being reported with the Mirena contraceptive device. They include:
- Perforation: The Mirena device can puncture or pierce the uterus causing internal scarring, infection or damage to other organs including the bladder and liver. A surgery may be required to remove it. These are serious complications that can be fatal.
- Embedment: The device can also become embedded in the uterine wall. Extensive surgery may be necessary to remove the device.
- Migration: The Mirena IUD may migrate outside of the uterus into the abdominal cavity resulting in the development of adhesions and abscesses. An obstruction or perforation to the intestines can also occur. When the device moves from its original location, it can no longer prevent pregnancy.
- Infections: The Mirena IUD can cause serious infections that cause scarring. This in turn may affect a woman’s fertility and her ability to have children. Severe infections can even lead to death. Examples of such infections include Group A streptococcal sepsis and toxic shock syndrome.
- Ectopic Pregnancy: This is a serious obstetrical complication in which a fertilized egg implants somewhere outside the uterus such as the fallopian tubes. There is a risk of rupture and internal bleeding that can pose a threat to a woman’s fertility as well as to her life.
- Intrauterine Pregnancy: This is a pregnancy that occurs while a Mirena device is in place. This can pose a serious risk to the baby. The Mirena IUD should be removed but poses a risk of miscarriage, infection and preterm birth.
- Pelvic Inflammatory Disease: This is a serious infection of the uterus or other reproductive organs caused by bacterial infections. If not treated effectively and in a timely manner, it can lead to infertility, ectopic pregnancies and persistent pelvic pain. Severe cases may lead to a hysterectomy.
These serious side effects from the defective Mirena devices can be severe causing debilitating injuries and in some cases, they can even be life threatening. Many women have required surgeries to remove the devices and others have had to endure the devastating and emotional consequences of having a hysterectomy.
Mirena IUD: Marketing Deception
Of interest is the fact that Bayer HealthCare Pharmaceuticals initially marketed the Mirena device through a campaign titled Simple Style Program that was targeting a client base of busy working mothers. The campaign consisted of presentations called “Mirena Parties” that were conducted in private settings including homes by a representative from a social networking site called “Mom Central” along with a nurse practitioner. The campaign stated that the Mirena device could improve intimacy, romance and physical appearance. The FDA sent a letter to the company in December 2009 warning that their marketing campaign contained misleading representations about the benefits of the device. The federal agency also informed the company that they omitted or were lacking in providing the proper information on the potential risks of using the device and also that they minimized or downplayed the risks by claiming that women would look and feel better. Bayer stopped having the parties.
Contact the Philadelphia Products Liability Lawyers at Galfand Berger – Committed to Helping Women Injured by the Mirena Intrauterine Device
The dedicated personal injury lawyers at Galfand Berger are currently working on behalf of women who have suffered the devastating side effects and injuries associated with the Mirena IUD device. Our experienced and skilled legal team is committed to holding the manufacturer liable for any harm they caused these women, for their negligence in not ensuring their product was safe, and for not properly warning consumers about the potential risks.
If you or someone you love has had or presently has a Mirena contraceptive device implanted, we urge you to contact the Galfand Berger law firm to discuss your options with one of our qualified product liability attorneys. We will determine if you have a valid claim and then proceed forward with a products liability lawsuit if appropriate. We will protect your rights and fight to secure you the fair and just compensation that you deserve. We have offices conveniently located in Philadelphia, Bethlehem and Reading, Pennsylvania, and serve clients throughout the Southeast Pennsylvania/South Jersey region, including the areas surrounding Allentown and Harrisburg in Pennsylvania and the Counties of Camden, Burlington, Salem and Gloucester in New Jersey. Call Galfand Berger today at 1-800-222-USWA (8792) to schedule a fee and confidential consultation with one of our products liability lawyers or submit a free online inquiry.