Amniotic Band Syndrome (ABS), also known as Congenital Band Syndrome or amniotic band constriction, is a disorder that occurs when an unborn baby’s limbs become trapped in fibrous amniotic bands. Although there are several reasons that ABS can develop, it’s been linked to women taking Zofran while pregnant.
More About Amniotic Band Syndrome
ABS occurs while a baby is still in utero and his/her limbs, which can include arms, legs, fingers or toes, become tangled in threadlike bands known as amniotic bands. This results in the baby developing abnormalities after birth.
ABS can range from mild to severe, and with the more serious conditions, ABS can cause miscarriages and limb amputations if the bands are wrapped around the infant’s limbs too tightly.
Birth Defects Caused By Amniotic Band Syndrome
Unfortunately, infants who go through ABS are prone to numerous types of birth defects, including:
- Cleft lip and cleft palate
- Distal ring constrictions
- Fingernail deformities
- Stunted growth
Treatment Options for Amniotic Band Syndrome
Before treatment options can be discerned, a physician will need to determine which of the baby’s limbs are entangled. Furthermore, the doctor will need to determine how severe the limbs are affected. Once these two factors are pinned down, the most common forms of treatment include:
- Freeing the limbs via surgery while the infant is still in the womb
- Plastic or reconstructive surgery after birth
- In severe cases, although rare, amputation of the affected limbs, and use of prosthetics
Amniotic Band Syndrome Prognosis
The long-term outlook of children with ABS will greatly depend on how severe the limbs were affected. Severe cases of ABS may have a grim outcome, and as mentioned earlier, may lead to miscarriages. Children with mild cases who take well to treatment generally have a favorable prognosis.
Amniotic Band Syndrome and Zofran Use
ABS is typically caused when there is damage to the amnion, a part of the placenta. Placenta damages has been linked to numerous factors, including taking certain medications while pregnant.
Zofran, an anti-nausea medication intended only for surgery and cancer patients, is being prescribed to pregnant women to help them with morning sickness. Since Zofran is not approved by the FDA for morning sickness, doctors are prescribing the medication to women as off-label use.
So far, there have been a few cases filed against GlaxoSmithKline, the makers of Zofran, after women had babies with ABS. For example, Deana Brown, a plaintiff who filed a Zofran lawsuit against GSK in 2014, gave birth to an infant girl with ABS and clubfoot. Brown was prescribed Zofran during her first trimester of pregnancy to help her with severe morning sickness, and according to her lawsuit, there is no history of these medical issues in her family.
Brown’s claim also indicates that,
“Pregnancy-related nausea presented an extremely lucrative business opportunity for GSK to expand its sales of Zofran, which before its patent ran out in 2006 was one of the most expensive drugs available in the U.S. market. GSK seized that opportunity, but the effect of its conduct was tantamount to experimenting with the lives of unsuspecting mothers-to-be and their babies.”
Brown’s lawsuit represents the 193rd Zofran lawsuit against GSK in 2015 alone. Other plaintiffs claim they also took Zofran while pregnant, and as a result, had infants with birth defects ranging from mild to life-threatening. Some mothers underwent a necessary abortion due to extreme birth defects, while others had miscarriages.
Keep in mind that you have the legal right to file for damages if you took Zofran while pregnant and your baby was injured. Although research is still ongoing, many medical and scientific studies have linked taking Zofran to a heightened risk of infants developing birth defects.