Running head: INTEGRATION OF ARTIFICIAL WOMBS 1

The Legal Process of Integrating Artificial Wombs into Neonatal Intensive Care Units

Matalynn M. Clark

Legal Studies Academy at First Colonial High School

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Abstract

This paper will address the legal process of integrating artificial wombs into neonatal

intensive care units. This development is a new technology that is predicted to be used on

humans in the near future. The history of artificial wombs, the purpose of the device, the current

practices in the NICU, and the impacts the womb will create will be addressed in this paper. In

addition, the paper will cover the FDA approval process, implications, parental consent, how

legislation will regulate the technology, and how the device affects health insurance.
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The Legal Process of Integrating Artificial Wombs into Neonatal Intensive Care Units

As advancements in the medical field occur, the chances for human survival increase. 1

in 10 babies born in the U.S. are premature, and the earlier they are born, the lower the chance of

survival. Premature birth is the number one leading cause of death for newborns. These babies

typically have health problems such as apnea, cerebral palsy, hemorrhages, and much more

life-altering conditions ("Preterm Birth," 2018). This leaves a need for a technology that can save

preemies and is ethical in doing so. Fortunately, Dr. Alan Flake, a pediatric and fetal surgeon,

and his team from the Children’s Hospital of Philadelphia, have come up with an idea that will

change the future for prematurely born babies.

Artificial wombs offer an opportunity to allow prematurely born babies to finish

developing successfully, but must endure a long process to become approved due to ethical and

legal concerns. With any technological advancement, the opportunity for abuse of the product is

present. Although the device promises great success in NICUs, the risk of it being taken

advantage of for other purposes hinders and creates hesitation within the process of making it a

commonly used technology. Because of this, the development must be strictly regulated. In order

for artificial wombs to reach hospital use in the United States, it must be approved by the FDA.

In addition, insurance companies and federal aid (such as Medicare) must decide if they will

cover the device.

Prematurity

Prematurity is defined as when a “newborn infant is delivered before term and is often

associated with a low birth weight, of less than 2,500 grams” (Prematurity and its consequences,
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2014). Prematurely born babies can be divided into certain categories, based on their birth weight

and how many weeks of gestation occured before being born. “Very premature” babies are born

before 32 weeks of gestation and would be candidates for an artificial womb. Specifically, the

ample candidate would be between 23-24 weeks of gestation, according to the team at CHOP

(Children’s Hospital of Philadelphia, 2017.)

Purpose

The Hippocratic Oath is a promise taken by physicians to do no harm. Flake’s plans are

to better the life of infants born prematurely, and provide another method of letting them fully

develop, one that will not lead to death, diseases, or life-altering conditions. Flake, the study

leader, claims the following:

[their] system could prevent the severe morbidity suffered by extremely premature

infants by potentially offering a medical technology that does not currently exist… These

infants have an urgent need for a bridge between the mother’s womb and the outside

world. If [the team] can develop an extra-uterine system to support growth and organ

maturation for only a few weeks, we can dramatically improve outcomes for extremely

premature babies (Children's Hospital of Philadelphia, 2017).

About the Device

Dr. Alan Flake and his team from the Children’s Hospital of Philadelphia have

successfully created an artificial womb. Learning from their previous studies, the artificial womb

attempts to mimic the human uterus as much as possible. The artificial womb consists of a

plastic bag, called a bio-bag, filled with laboratory-made, synthetic amniotic fluid. According to
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the fetal physiologist who designed the flow of the system, Marcus G. Davey, PhD, “fetal lungs

are designed to function in fluid, and we simulate that environment here, allowing the lungs and

other organs to develop, while supplying nutrients and growth factors” (Children's Hospital of

Philadelphia, 2017). Because the tiniest amount of pressure could destroy a newborn’s heart,

there is no circulating external pump. In addition, there is no ventilator, since preemie’s lungs are

not yet ready to breathe oxygen, like developed babies can. Because of this, the artificial womb

has the heart pump blood via the baby’s umbilical cord, that is attached to an oxygenator. This

machine acts as the placenta, providing nutrients and oxygen to the fetus, while removing carbon

dioxide.

The human fetus would be transplanted from the mother to the artificial womb between

23 and 24 weeks of gestation after a C-section where the baby would be given a drug to prevent

breathing while out of the womb (Partridge et al, 2017). This “allows the fetus to swallow and

breathe amniotic fluid, like it’s supposed to during development,” Flake said (Andrews, 2017).

From here, the baby would remain in the womb until substantially developed.

Previous Systems

There has been many previous attempts at creating an artificial womb before the most

recent one has been created. Concepts of artificial wombs have been known dating back to

different points in history. In 1955, Emanuel M. Greenberg created just a design of an artificial

womb (Zhan Wei, 2017). Yet, this hypothetical device did not become practical until much more

recently. In 1996, at Juntendo University in Tokyo, Dr. ​Yoshinori Kuwabara led a team in

creating a system that allowed for underdeveloped goats to grow. Despite successfully keeping
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the goat fetuses alive in the system for three weeks, many issues occured to the goats (Carlston,

2009, p. [Page 36]). Artificial wombs came back into the spotlight once studies began at the

Children’s Hospital of Philadelphia in 2014. The first model of the artificial womb system at

CHOP consisted of a glass incubator tank, and has since developed into what it is today

(Children's Hospital of Philadelphia, 2017).

Promising Results

Premature lambs were used to test the device. The results were extremely successful;

lambs that could not have otherwise survived alone, lived up to four weeks in the biobag. A

video released from the Children’s Hospital of Philadelphia shows a living lamb in the artificial

womb five days after it had been removed from its biological mother. The video shows the

lamb’s development at 105 days of gestation is equal to other lamb fetuses still in their biological

mother (Children's Hospital of Philadelphia, 2017). Once removed from the device, the

developments of the lambs, such as their lungs, were equal to lambs in their own mother who

were not born prematurely (Swetlitz, 2017). “The lambs showed normal breathing and

swallowing, opened their eyes, grew wool, became more active, and had normal growth,

neurological function and organ maturation” (Children's Hospital of Philadelphia, 2017).

However, Flake’s purpose of this trial was to only focus on the development of the lambs in the

biobag, so the subjects were euthanized shortly after being removed from the device.

Interestingly, one of the lambs was not killed, and was donated to a farm (Swetlitz, 2017).

Implications

Ethical Concerns
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​Despite the potential success with saving preemies, concerns of abuse are evident. There

is worry that artificial wombs will get rid of maternity leave, allow women to escape pregnancy,

and serve as an alternative to abortions.

Similar abuse. ​There are many examples of abuse of technologies in the past. Dolly the

Sheep shows how a perfectly acceptable topic of cloning cells can easily become abused. The

cloning of stem cells can be used to create solutions for treatments of cancer; however, two

scientists from the Roslin Institute took advantage of this research. They created a cloned sheep

out of adult somatic cells through nuclear transfer. Dolly became the first adult mammal ever

cloned, but quickly showed significant negative consequences, such as lung disease and severe

arthritis (Roslin Institute, 2016).

Materialistic motives. ​“Bioethicists worry that another subset of women will employ

fake wombs for convenience, to avoid stretch marks and weight gain or to prolong Hollywood

careers,” says Gretchen Reynolds, a journalist who interviewed bioethicist, Thomas Murray

(Reynolds, 2005). The fear is that artificial wombs will serve as an escape from the physical

aspects of pregnancy, while still bearing a child.

Maternity leave. ​Rob Stein, the senior editor in chief of NPR, sat down with Flake to

have a conversation about how his invention affects maternity leave. Basically, “women could be

coerced into using artificial wombs by employers who don't want to pay for maternity leave or

insurers who don't want to pay for expensive pregnancies” ("Scientists Create Artificial Womb

That Could Help Prematurely Born Babies," 2017). Once again, Flake does not intend the womb

to expand to this far of measures.

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Alternative to abortions. ​The issue of abortion rights has swept across the nation. ​Roe v.

Wade​ established that abortions may be practiced within the first trimester. Any other guidelines

are left up to the states to decide. The issue arises if it is acceptable to use an artificial womb as

an alternative to abortion. This means that once the fetus reaches 23 weeks of gestation, it can be

placed in an artificial womb to finish developing, so that it would no longer be the mother’s

responsibility. When the baby is born, it would go to foster care. This truly poses a situation

where one is stuck between a rock and a hard place. For, is it acceptable to terminate a fetus, or

allow it to be placed in a non living womb, destined to grow up in the foster care system? Once

more, Flake suggests he has created an artificial womb to save premature born babies, and it is

not intended to be used for an alternative for abortions. However, his invention, once further

developed, could pose as a great solution to the abortion debate. Glenn Cohen, a Harvard

bioethicist, from here, confronts if “whether or not a woman has a right to stop carrying a child,

and whether or not from there if she has the right to control what happens to the child after she

stops carrying it” (O'Bannon, 2017).

A need for regulation. ​In order for artificial wombs to be used for the intended purpose

of serving as a place for prematurely born babies to finish developing, legislation must occur to

regulate the technology and not allow for the concerns to become reality. By guaranteeing these

abuses will not occur, the integration process will go much smoother.

Physical Limitations

As with any developing technology, there exists some challenges and unknowns. The

artificial womb can be contaminated. In addition, it is very hard to stick tubes into the fetus’s
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umbilical cord, since the cord shrinks when exposed to oxygen, a situation that will occur

between the caesarean section and the sealment of the biobag. Also, although not exhibited in the

trials with lambs, brain bleeding could occur which could result in death (Swetlitz, 2017). Like

other technologies, challenges and issues must be solved before the development can be

universally used. Through more research and trials, these problems will eventually be solved.

Hesitation

Another issue that might hinder the advancement of the device is the pure concept of

artificial wombs. The idea of an artificial womb imposes a futuristic, science-fiction, negative

connotation that might steer parents away. According to Dr. Brian Gray, a pediatric surgeon at

Riley Hospital for Children, “[he has] talked to other practitioners who think that families might

not be able to accept that their baby is going to be placed in a bag for four weeks. It’s very

science fiction-y. Some people might not be able to accept that” (Swetlitz, 2017).

Hopefully, through more successful results from of upcoming trials, parents will

disregard the alarming, futuristic concept of artificial wombs that have been predisposed in their

heads. They will understand the benefits the womb will offer.

Current Practices

Currently, when a preemie is born, it is typically placed in an incubator. This incubator

regulates a warm temperature to maintain a certain body heat level. It monitors a humidity so

that the newborn maintains a certain hydration level. Also, the incubator reduces the chance of

infection. In addition, while the baby is in the incubator, there are many wires and tubes attached

to the baby in order to monitor it’s health. Assistive devices, like a respirator, may be present to
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assist the baby. Ventilators are currently the best used practice for under developed lungs. The

ventilator forces oxygens into the infant. Dr. George Mychaliska, a pediatric and fetal surgeon at

C.S. Mott’s Children's Hospital, weighs in on ventilator practice, “we know that even a few

hours of [ventilators] damages the lungs of a 24-week infant. Our hands are tied, because in the

absence of that, the baby would die. So we accept some lung damage to keep the baby alive”

(Swetlitz, 2017). Finally, the baby may need to have surgery that differentiates depending on

each case. This sight is very intimidating and it is evident that the baby is uncomfortable.

Although the current practice of treating premature babies has a high chance of survival

(but 50% change for babies born between 22-23 weeks of gestation (Swetlitz, 2017).)- life long

conditions develop as a result of the baby being born. For instance, cerebral palsy can occur

through “non-functional or inappropriate connections (synapses) between brain cells – trauma,

infections, and asphyxia that damage connections developed in the brain” (Causes of Cerebral

Palsy, 2018). If a baby’s lungs are not fully developed, a lack of oxygen to the brain may occur

and cause this condition that affects the motor control of an individual.

Artificial wombs act as another form of treatment for preemies. Instead of enduring the

uncomfortableness and risk of conditions that an incubator imposes, the newborn can peacefully

finish developing in an womb instead. Then, when the baby is fully developed and able to

survive alone in the outside world, it can be delivered once again.

FDA Approval

In order for artificial wombs to integrate into NICUs, FDA approval must be given. The

Section 201(h) of the Food, Drugs and Cosmetics Act defines a medical device as “any
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healthcare product that does not achieve its principal intended purposes by chemical action or by

being metabolized” (Faris, O., Ph.D, 2006). An artificial womb is a Class III medical device,

which means it is high-risk and must be approved by the Food and Drug Administration before

hitting the market. ​Specifically, the process consists of establishment registration, medical device

listing, premarket approval, Investigational Device Exemption for studies, Quality System

Regulation, labeling requirements, and Medical Device Reporting. This criteria can be met by

lab, animal, and human trials as proof that can be submitted to the FDA. ​In order for the device

to be approved, it must demonstrate “​reasonable assurance of safety and effectiveness” (How to

get FDA Approval, 2018).

Lab and animal trials, previously discussed, have already been conducted and suggest

evidence of this device being successful, but no human trials have been conducted. In order for

human trials to be conducted, an Investigational Device Exemption (IDE) request must be

granted from the FDA. This allows the device to be tested on humans even though it has not

received FDA approval. Once, the IDE is approved, the trials may start. The biggest factor The

Children’s Hospital of Philadelphia will have to prove is that the anticipated benefits of this

device outweigh the risks. CHOP plans on reaching this step in the FDA approval process within

the next three to five years. This means, that if everything goes as plan, the device could hit the

market within the next decade. The human trial part of the federal approval process is the

greatest step the team must face.

Insurance Coverage
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According to the March of Dimes, on average, a preemie stays in the intensive care unit

for about 13.2 days. This average cost of this stay is about $76,000. For babies born prior to 32

weeks (some candidates for artificial wombs), the medical bill can exceed up to $280,000

(March of Dimes, 2014). It is also important to consider the life-long conditions that may result

out of being prematurely born. This adds to even more medical costs. Depending on a family’s

insurance plan, the amount of coverage given varies. Many private medical insurance policies

will cover the entire hospitalization of the newborn; however, some will not cover the entire cost.

Medicaid and other government programs also may cover the costs.

Since other medical devices are used during the NICU stay, and are, therefore, covered

by most insurances, when artificial wombs are integrated into hospitals, it is evident that they

will also be covered. However, artificial wombs must be used for its intended purpose-

development of prematurely born babies. It is also important to highlight that currently, medical

costs arise from further issues that must be treated, that resulted from treatment of the preemie.

For example, if the newborn has cerebral palsy, as a result from being born prematurely, then

throughout the child’s life, many visits to the hospital, medication, operations, etc. will be

conducted- which costs money. Through artificial womb treatment, life-altering conditions

would not occur, and as a result prolonged medical bills will not be produced.

Parental Consent

The Twenty-Sixth amendment, passed in 1971, gave citizens 18 and older the right to

vote. This legislation created a nation-wide separation of an adult from a minor. Because of this,

a legal parent/guardian is to have the ultimate say in decisions regarding their minor (Journal of
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Midwifery Womens Health, 2003). Within the neonatal intensive care unit, newborns are unable

to make their own decisions, which is why parents must give consent to any medical practices

that the baby will undergo. Parent will give informed-consent, hopefully acting in the best

interest of their baby. This means that the medical providers will offer the best information about

the current situation, causes and effects, risks, benefits, etc. From here the parent will make a

decision as to follow through with a certain medical practice or not. Issues arise when the legal

parent/guardian does not agree with what the best interest of the baby is. From here, it is in the

best interest of the medical provider and legal parent/guardian to respect each other as equal

makers in the decision process (Sundean, 2013). Because artificial wombs currently come with a

negative connotation to most people, when the medical device does become a treatment method

for prematurity, parents may be hesitant. This issue must be discussed with all participating

parties in order for the baby to receive the best treatment plan possible, whether or not that is an

artificial womb.

Similar Precedents

Although artificial wombs are currently pushing the boundaries of development

treatment, other medical devices and practices are also testing the limits, in other aspects of the

reproductive process. Reproductive technologies and infertility treatments have assisted

numerous families have children, such as in vitro fertilization and gestational surrogates (U.S.

National Library of Medicine, 2018). These methods previously were (some, still) considered

controversial. In vitro fertilization, as well as surrogacy, are often looked down upon. Some

claim that these type of infertility treatment rid the natural process of pregnancy. However,
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nevertheless, they are still legal. In vitro and surrogacy include the help of allowing a woman to

bear children- something the woman typically cannot do if she is using this type of reproductive

therapy. This means that the fetus has not already existed before the type treatment was given.

This means, that if these practices are allowed to voluntarily help in the pregnancy process, then

artificial wombs, something that will be critical to survival (not voluntary), should definitely be

made legal. Of course, this is to not neglect the need for strict regulation due to easy abuse.

Even recently, the first healthy baby was born from a deceased-donor uterus transplant.

In Sao Paulo, Brazil, the “first successful uterus transplant was [a] deceased donor [that led] to a

healthy baby” (Weintraub, 2018). The woman had no pregnancy issues and successfully birthed

the baby through caesarean section. Although this has happened in Brazil, similar practices are

happening/soon to happen in the United States. Dr. Kate O’neill, co-lead investigator for the

uterus transplant program and the University of Pennsylvania says her and her team have

planned live and deceased uterus operations within the next year. Other locations, such as the

Baylor College of Medicine and Cleveland Clinic, have already performed live donor donations

and are soon to have a deceased donor operation (Weintraub, 2018). Deceased-donor uterus

transplants started in countries where surrogacy is not a method of infertility treatment due to

ethical, legal, and religious barriers. If the uterus transplants are still allowed in the United

States, where surrogacy is allowed, then artificial wombs should also be allowed; considering it

means the transplants are not necessarily needed, while artificial wombs are. In addition, this

process created risks for the mother and the child, that could have resulted in the death of both.
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Artificial wombs only pose some risks for the child, therefore, the device should also be able to

conduct human tests.

Conclusion

Different treatment, medications, technology, and medical treatments are created

everyday in the healthcare universe. The ultimate goal of each of these developments is to make

people healthier. However, despite the benefits that will arise from them, they must follow a

timely process to become integrated into hospitals.

An artificial womb is a medical device that is early in the development process. It offers

numerous anticipated benefits, acting as an alternative to traditional practices of preemie

treatment. Many issues still must be addressed and solved- but eventually, through more research

and trials, the implications will likely be solved. The intended purpose of the womb is to be used

with extremely prematurely born babies. They will be placed in the device to finish developing,

free of the issues and uncomfortableness that comes with the current practice of incubators.

Despite the intended purpose, the product could be abused and used for other motives- such as

anti-abortion solutions or maternity leave abolishment. Because of this, when the device is ready

to hit the market, strict regulation is necessary. In the United States, the FDA must approve the

device, and from there it can begin to integrate into hospitals. Nevertheless, the FDA approval

process is very lengthy, and the team behind the womb must provide substantial evidence that

the anticipated benefits of the device outweigh the risks. Once the womb is on the market,

insurance policies, according to other precedents, will most likely cover the costs of this part of

the NICU.
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Artificial wombs have a long journey ahead of them until they will be successfully

integrated into neonatal intensive care units. However, once they complete the process described

in this paper, the device will finally be able to carry out its intended purpose- to save preemies.

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