ventouse delivery; vacuum extractor; vacuum extraction; vacuum-assisted delivery

The Odon Device: New Alternative to Forceps and Vacuum Extractors?

Operative devices such as forceps and vacuum extractors can help guide babies out of the birth canal. Forceps resemble a pair of large tongs, which are placed on either side of the baby’s head. A vacuum extractor uses a small, soft cup that is applied to the top and back of the baby’s head. Gentle suction from the vacuum assists in pulling the baby’s head out of the pelvis.  

It is imperative that physicians using either of these devices are highly trained, understand the circumstances under which their use is and isn’t appropriate, and exercise great caution in their placement and the amount of pressure applied. When physicians are well-experienced in operative deliveries and follow medical standards of care, these devices usually are safe and effective. However, when standards of care are not followed or the physician is unskilled, serious traumatic birth injuries to the baby can result (1). 

Issues associated with the incorrect use of forceps and vacuum extractors can include the following (2):

Some children may also sustain forms of neonatal brain damage (such as hypoxic-ischemic encephalopathy, or HIE) and disabilities like cerebral palsy and epilepsy due to misuse of these tools. 

A new, potentially safer delivery device

Jorge Odón, an Argentinian car mechanic, invented the Odon device in 2006. He was inspired to do so after seeing a trick for removing corks from wine bottles (more on his story here) (3, 4). He later worked with the World Health Organization (WHO) to develop a prototype that was used to demonstrate efficacy and safety. 

To use the Odon device, a clinician inserts a soft cup and a double layer of plastic into the birth canal, to surround the baby’s head. They then pump a small amount of air into this bag, which causes the Odon device to gently grip the head. In pictures, this looks quite alarming because it covers the baby’s airways. However, it is important to remember that babies do not really breathe until birth; rather, they rely on the umbilical cord for oxygen and gas exchange in-utero. Then, they pull on the handle in order to deliver the baby’s head (3, 4).

Dr. Mario Merialdi, WHO chief coordinator for improving maternal and perinatal health, told the BBC that his expectations were low when he first met with Odón. “I was intrigued, but also skeptical because for many years, almost centuries, there has been no innovation in this area of work,” he said (4). However, he and other medical experts quickly began to see the potential of the Odon device, especially for use in developing countries. The Odon device is relatively simple and inexpensive to produce; it could help prevent complications associated with prolonged and obstructed labor, which are extremely common in developing countries. These include (4):

Some of these issues also regularly occur in developed countries (especially in association with medical malpractice); use of the Odon device would certainly not only be useful in developing countries. In more developed countries, it could also reduce the need for Cesarean sections (C-sections). 

The WHO began running tests on the Odon device in 2011, and in 2013, it was licensed by Beckton, Dickinson and Company (BD), which committed to manufacture and commercialize it on a global scale (3). They are still working to make it available to the public. BD’s executive vice president, Gary Cohen, told NPR (in August, 2018) that the process is taking about twice as long as originally expected. “We underestimated how complex and challenging it would be. But every specification has to be vetted,” he said.  A clinical trial of the Odon device is ongoing. Certain complications (including vaginal, cervical, and perineal tears) have been identified, and risks must be minimized (5).

Although the process has been complicated, many medical experts still think the Odon device could be life-saving. As for Jorge Odón, he has handed over his mechanic workshop to his son, to focus full-time on the Odon device and other health-related innovations (4, 5). Nevertheless, his experience as a mechanic continues to guide his thought processes. As Merialdi explained to the BBC,

Albert Einstein used to say that sometimes imagination is more important than knowledge and this is actually the case, because Jorge didn’t have any knowledge of obstetrics. It’s also true that although delivery is a biological function, it’s also a mechanical process and so it’s not surprising that a mechanic found a way to solve the problem of protracted or obstructed labor. I doubt an obstetrician like me would have thought of a plastic bag with an air chamber in it,” (4).

Other alternatives to forceps and vacuum extractor deliveries

Given the potential for severe injury when forceps and vacuum extractors are used, it is important for physicians to be knowledgeable about operative delivery alternatives.

Alternatives to instrument delivery include the following:

  • C-section.  A C-section is performed when a vaginal delivery would put the baby’s or mother’s life or health at risk. Some conditions that require the baby to be delivered immediately include fetal distress, uterine rupture, and umbilical cord prolapse. Sometimes physicians fail to perform an emergency C-section when one is indicated, or they wait too long to perform one. Other times, the C-section may be ordered, but the physician lacks skill in the procedure, or the hospital is ill-equipped for it.  Delay in performing a necessary C-section can lead to permanent injuries in the baby, such as hypoxic-ischemic encephalopathy (HIE) and cerebral palsy. In many cases, a C-section is the safest way to deliver the baby.  Thus, it is critical that physicians be skilled and prepared for the procedure.
  • Expectant management. This involves non-intervention by the physician and allowing the pregnancy to progress. When expectant management is utilized, very close monitoring of the mother and baby is essential.  Expectant management can include delayed pushing, maternal rest, change in maternal position, reduction in anesthesia, and emotional support.
  • Use of Pitocin (oxytocin). This drug is used to induce or speed up labor. In some instances, Pitocin is effective, and the baby is born without complications. In other cases, it can be very dangerous, especially if used when it shouldn’t be, or in too high a dosage. Pitocin can cause a condition called hyperstimulation of the uterus (also known as uterine tachysystole), which means that the mother’s contractions are excessively frequent, long, or intense.  Contractions push or impinge on the blood vessels that deliver oxygen-rich blood to the baby. When there is too much uterine activity, the baby can become dangerously deprived of oxygen. Pitocin can be helpful during delivery, but due to its risky nature, it must only be used in very select circumstances, and the mother and baby must be closely monitored (6).

About ABC Law Centers

ABC Law Centers was established to focus exclusively on birth injury cases. A “birth injury” is any type of harm to a baby that occurs just before, during, or after birth. This includes issues such as oxygen deprivation, infection, and trauma. While some children with birth injuries make a complete recovery, others develop lifelong conditions such as cerebral palsy and intellectual disabilities.

If a birth injury/subsequent disability could have been prevented with proper care, then it constitutes medical malpractice. Settlements from birth injury cases can cover the costs of lifelong treatment, care, educational resources, and more.

If you believe you may have a birth injury case for your child, please contact us today to learn more. We are happy to talk to you free of any obligation or charge. In fact, clients pay nothing throughout the entire legal process unless we win.

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Sources

  1. ABC Law Centers | Vacuum Extractor Injuries. (n.d.). Retrieved June 27, 2019, from https://www.abclawcenters.com/practice-areas/prenatal-birth-injuries/traumatic-birth-injuries/forceps-and-vacuum-extractor-injuries/ 
  2. (n.d.). Retrieved June 27, 2019, from https://www.uptodate.com/contents/operative-vaginal-delivery 
  3. BD Odon Device™. (n.d.). Retrieved June 27, 2019, from https://www.bd.com/en-us/company/global-health/maternal-and-newborn-health/labor-and-delivery/bd-odon-device 
  4. Venema, V. (2013, December 03). Odon childbirth device: Car mechanic uncorks a revolution. Retrieved June 27, 2019, from https://www.bbc.com/news/magazine-25137800 
  5. Hallett, V. (2018, August 26). Whatever Happened To … The Car Mechanic Who Invented A Device To Pop Out A Baby? Retrieved June 27, 2019, from https://www.npr.org/sections/goatsandsoda/2018/08/26/637472896/whatever-happened-to-the-car-mechanic-who-invented-a-device-to-pop-out-a-baby 
  6. Pitocin During Labor Can Cause Birth Injuries. (n.d.). Retrieved June 27, 2019, from https://www.abclawcenters.com/practice-areas/prenatal-birth-injuries/labor-and-delivery-medication-errors/pitocin-and-oxytocin/ 

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