12:00

The result, the device becomes very

12:02

popular very quickly, but it also

12:04

very quickly has a lot of

12:06

problems. Some reports said

12:08

it required 10 times more force

12:10

compared to other IUDs to be

12:12

able to insert this device. Oh

12:15

my God. Which is really horrific.

12:17

There was a Washington Post report where

12:20

a doctor said he found it

12:22

was the most traumatic manipulation ever

12:24

perpetrated on womanhood. So because of

12:26

this, there are problems with perforations

12:29

of the uterine wall. And there

12:31

also may be problems with non-sterile

12:34

insertion processes. Another

12:37

significant flaw with the Dalkan Shield, and this

12:39

is the most famous flaw, is

12:42

that IUDs have strings to pull them

12:44

out. String

12:46

used in the Dalkan Shield was a

12:48

multifilament string. And so the effect of

12:50

this is that there's a lot of

12:53

surface area for bacteria to sort of,

12:55

one researcher put it to me, like

12:57

the itsy bitsy spider, climb up the

13:00

water spout, climb up, in this case,

13:02

the multifilament strings, and kind of

13:04

get into a woman's body and be able

13:06

to cause infections. And the

13:08

estimates are about 18 women

13:10

died, and it caused hundreds

13:12

of thousands of infections, in

13:14

many cases infertility, septic abortions,

13:17

miscarriages, just like a whole

13:19

train of tragedy. There

13:21

was also a number of lawsuits,

13:24

understandably, against the device. Eventually,

13:27

the company that manufactured it

13:29

set up a trust fund

13:31

that paid some $3 billion

13:34

as a result of these class action lawsuits.

13:37

And so the effect of this, obviously, the most tragic

13:39

effect is the effect on women's

13:41

lives. But there's also a significant effect on

13:44

the IUD market in the US, which is

13:46

after the Dalkan Shield tragedy, IUD

13:49

use in the US plummets, almost

13:51

all of the manufacturers of

13:54

IUDs actually end up pulling their devices

13:56

off the market, just because women

13:58

are understandably now sent to

14:00

insert any IUD even beyond the

14:03

dalkan shield. When

14:09

we come back, how the IUD went

14:11

from horror story to symbol of reproductive

14:14

freedom. This

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16:13

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16:17

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16:20

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16:23

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Wireless. Full terms at mintmobile.com. The Dalkin Shield

17:20

tragedy made IUDs seem terrifying,

17:23

but it also did something else.

17:26

It created the impetus for the government to

17:28

act. Congress

17:30

establishes three different classes of medical

17:32

devices that, depending on the risk

17:35

that they pose to patients,

17:37

require different levels of pre-market review

17:40

before they can be inserted,

17:42

right, or be marketed. This

17:44

is really important because the reason that the

17:47

Dalkin Shield had so many problems is

17:50

because it was not tested in any sort

17:52

of systematic way before it was being inserted

17:54

into women's bodies, right? It was being tested

17:57

live on women as it was being tested.

18:00

getting inserted. There was some sort of

18:02

like pre-market test of 600 women

18:05

that was run by the

18:07

devices inventor before it was kind of

18:09

brought to market. But again, that raises

18:11

a number of red flags. So

18:13

as a result, the Congress

18:15

gives the FDA much more power to

18:18

regulate medical devices. Today, IUDs are actually

18:20

regulated not just as devices, but as

18:22

drugs because of their hormones and copper,

18:24

which means that they have to go

18:26

through even more testing and review before

18:28

they're put onto the market. So that's

18:31

really good. It's really important. It means

18:33

that the IUDs that we have today,

18:35

we can trust. We do know that

18:37

they're safe. I feel like

18:39

suddenly in the

18:42

early 2000s, 2010s, IUDs

18:44

really took off in

18:46

popularity. What drove that?

18:49

There are a couple of factors here. One is

18:51

that it is a scientifically very good

18:53

device and we now knew that. These

18:56

new devices that were on the market

18:58

had track records in Europe

19:01

and other places. They had the regulatory

19:03

track records. We knew that they were

19:05

safe. There was also a moment that was

19:08

politically really scary. We start

19:10

to see this conversation about

19:13

limiting reproductive rights and freedoms.

19:15

And so for a lot of women,

19:18

this idea of a device that you

19:20

can insert that is low maintenance and

19:22

that protects you for several years becomes

19:25

really appealing. We also have the Affordable

19:27

Care Act, which expands coverage of contraceptives

19:29

under insurance. This makes devices much more

19:31

accessible for women because sort of the

19:34

sticker price of a lot of these

19:36

devices is like a thousand dollars. So

19:38

it's really hard for folks who don't

19:40

have that covered by insurance to be

19:43

able to afford an IUD.

19:46

And then we also just sort

19:48

of see this culmination of media

19:50

attention and public health attention marking

19:53

the IUD now as like the

19:55

best contraceptive, right? This new age

19:57

of like the IUD as the