Among the many birth defects associated with the maternal use of prescription medications during pregnancy is cloacal exstrophy, a rare congenital abnormality characterized by a portion of the large intestines protruding outside the body. This condition often causes the splitting of both male and female genitalia, and the anus is occasionally sealed. Cloacal exstrophy is an extremely rare birth defect, occurring in only one in 200,000 live births.

Cloacal Exstrophy Suit Review: If you or somebody you know gave birth to a child who was diagnosed with cloacal exstrophy after being exposed to prescription medications in the womb, you should contact our lawyers immediately. Consultations are always free. Please use our confidential email contact form or call toll free 24 hrs/day by dialing (866) 588-0600.

Which drugs have been linked to cloacal exstrophy?

Cloacal exstrophy begins to manifest itself very early on in pregnancy, about four to five weeks after conception. It is at this stage that the various organs and different types of muscles and tissues begin to divide and fold. In cloacal exstrophy, something goes wrong at this early stage of development, causing the cloacal membrane to fail to close, leaving the large intestines outside of the abdominal wall. What causes the condition is still not clearly understood, but mounting research and numerous case studies have linked the following prescription drugs to the development of cloacal exstrophy when taken by expecting mothers (particularly during the first trimester, a time when many women may still be unaware they are pregnant):

  • Paxil (paroxetine)
  • Zoloft (sertraline)
  • Celexa (citalopram)
  • Prozac (fluoxetine)
  • Lexapro (escitalopram)
  • Symbyax (fluoxetine and olanzapine)
  • Wellbutrin (bupropion)
  • Effexor (venlafaxine)

Cloacal Exstrophy Overview

During early embryonic development, a cloaca is a common passageway for feces, urine and reproduction. The far end of a structure called the hindgut is the cloaca before it divides and separates to form a rectum, bladder, and genitalia.

Exstrophy is the eversion of a hollow organ at birth. In exstrophy of the cloacal, an area of the intestine is interposed between two separate areas of the bladder. Different manifestations of this defect result in a significant anatomic disarray.

While cloacal exstrophy can be present in both boys and girls, the condition tends to be far more devastating in males. Boys with cloacal exstrophy often have cryptorchidism (failure of descent of the testes into the scrotum) and severe epispadias (where the urine opening occurs above the phallus). These problems are so severe that it makes reconstruction of the male genitalia extremely difficult, if not impossible. In some cases, gender reassignment has been attempted, making boys with cloacal exstrophy into apparent girls. This procedure is highly controversial, and has been widely criticized by many in the medical community.

OEIS Syndrome

Cloacal exstrophy is also commonly referred to as OEIS Syndrome because of the following four features that are typically found accompanying the condition:

  • Omphalocele: Occurs when abdominal organs spill out through an opening in the abdominal muscles in the area of the umbilical cord.
  • Exstrophy of the bladder or rectum: The bladder is open and separated into two halves. The rectum and colon are similarly divided, and the segment of the rectum is placed between the bladder halves on the surface of the abdomen.
  • Imperforate anus: The anus has not been formed or perforated and the colon connects to the bladder.
  • Spinal defects: May occur in a variety of manifestations, either major or minor. Often times children born with cloacal exstrophy are also born with spina bifida.


In certain cases, cloacal exstrophy can be diagnosed when the baby is still in the womb with a prenatal ultrasound, and may be confirmed by magnetic resonance imaging (MRI). After birth, the diagnosis may be determined by a routine physical examination. Other diagnostic tests and procedures may include:

  • computerized tomography scan (CT scan)
  • magnetic resonance imaging (MRI)
  • endoscopy
  • abdominal ultrasound


Depending on the type and severity of the condition, a number of treatment options may be available for babies born with cloacal exstrophy. Initial assessment of the infant should focus on stabilizing the medical status and determining if other accompanying congenital defects make reconstruction a viable option.

  • Initial Closure: Typically performed soon after birth, initial closure involves closing the bladder and bringing the pelvic bones together into their normal ring structure. The bowel is then brought out to a stoma (bag) on the wall of the abdomen. If the infant is not healthy enough to tolerate a procedure of this magnitude, the bowel is removed from the abdominal wall, the bladder halves are brought together, and a colostomy operation is performed.
  • Continence Repair: If bladder closure is delayed because of accompanying congenital abnormalities, closure is typically performed at around one year old. Between the ages of four and seven, an operation to regulate urinary continence is performed. This procedure involves a reconstruction of the bladder outlet to prevent urine leakage. During the operation, the ureters (tubes that carry urine from the kidneys to the bladder) are also repositioned. The bowel may then be used to further increase the size of the bladder in those patients who have a small bladder size.

Is there a time limit in filing a cloacal exstrophy lawsuit?

Although we encourage all our potential clients to take great care in selecting their cloacal exstrophy lawyer, it is important that you understand that time is of the essence. The applicable statute of limitations in your state may time bar your claim. Furthermore, we are unable to provide you with legal advice without first evaluating your potential case. Accordingly, please take the time now to contact us by using the confidential email contact form below or by calling us toll free 24 hrs/day by dialing (866) 588-0600.

We hope we will be able to assist you with your potential cloacal exstrophy birth defects lawsuit and look forward to speaking with you.

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