Fw: Missouri Doctors Challenge Breast Implant Informed Consent Law

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> Missouri Doctors Challenge Breast Implant Informed Consent Law

> The St. Louis Daily Record

> Jan. 22, 2001

> By R. Brown - Staff Writer

>

> In the midst of a nationwide uproar over health concerns resulting from

> breast implant ruptures, in 1999 Missouri became the second of only two

> states to pass a law requiring physicians to tell patients of the risks

> associated with silicone and saline breast implants.

>

> Doctors have not taken the government's intrusion in what they must tell

> their patients in stride, however. The state's largest physician group

> is up in arms about the law that requires a prospective breast implant

> patient to sign a form acknowledging that her attending physician gave

her

> Department of Health information on the risks of breast implants at least

> five days prior to surgery.

>

> The 5,700-member Missouri State Medical Association, made up of medical

> students, physicians and retired physicians -- lobbied against the bill,

> which was scuttled early in the 1999 legislative session. But on the

final

> day of the session, the measure was tacked on to a bill dealing with

> insurance coverage for cancer screening and passed.

>

> The argument that the MSMA will bring to the Missouri Supreme Court on

> Feb. 1 is that adding the breast implant requirement to an unrelated bill

> is unconstitutional. The Circuit Court of Cole County had denied the

MSMA's petition for relief.

>

> " The constitution indicates that the purpose of a bill can't be changed

> from its original purpose, " said Duane Schreimann, attorney for the MSMA.

> " In this case, the original purpose was simply an act relating to

> insurance coverage for cancer early detection. Mandated information on

> breast implants, in our view, has nothing to do with that. "

>

> Doctors say the problem with the breast implant informed consent law

goes

> deeper than the constitutionality issue. The information that they are

> required to give patients is out-of-date and inaccurate, said plastic

> surgeon Dr. Huffaker of St. Louis Cosmetic Surgery and president

of

> the St. Louis Area Plastic Surgeons group. The MSMA's Web site states that

> plastic surgeons across the state began receiving the Department of Health

> materials and " many found them to be inaccurate, out-of-date, and

> contradictory to the information already being provided to breast implant

> patients. "

>

> In complying with the law, the Missouri Department of Health distributed

a

> Food and Drug Administration booklet, which Huffaker said was published

in

> 1995. " It just really contained inaccurate information, misleading

> information, " said Huffaker, adding that plastic surgeons are in favor of

> giving patients the information they need about any surgery.

>

> Huffaker continued, " If we give out information to people, we want it to

> be accurate and up-to-date, and when you get the government involved in

> it, it's not necessarily the most up-to-date information. We're locked

> into giving them a 1995 book that's old. "

>

> A more fundamental underlying issue is the medical community's distaste

> of the government inserting its presence in doctors' practices. Many

> doctors believe that dictating what materials must be given to a patient

> violates their ability to do their job as they see fit.

>

> " Our point is that we don't feel that the government should be in a

> position to dictate to us what information is discussed between patient

> and physician, " said Huffaker. " If the patient doesn't feel that they

> get adequate information from us and have surgery, they have redress

> through the medical board of healing arts or the legal system to sue us

if

> they feel we did not inform them properly before surgery. I mean, they

> already have these avenues. "

>

> The MSMA's attorney said that changing the materials provided by the DOH

> still wouldn't take away doctors' opposition of the bill. " I think if

> the information that's mandated to be provided to patients is updated and

> more accurate, that alleviates a lot of the concern, but I still think

> there is a significant concern about the government - whether it's state

> government or federal government - mandating what a physician must tell a

> patient. . . . We think it's a dangerous precedent to, in essence, be

> telling the physicians what those physicians must tell a patient. So I

> think it's a dangerous encroachment on the physician/patient privilege, "

> said Schreimann.

>

> Huffaker said that the DOH information is of little help to his patients.

> " I will tell you quite frankly a patient picks it up, looks at the book

> and lays it down and I don't think even opens it. " Huffaker said that

> most of the information has to do with silicone implants and not the

> saline implants that plastic surgeons primarily use for breast

> augmentation. " So it just doesn't even apply to most of our patients, "

> he said.

>

> But Kathy L. ley ston R.N., L.N.C., said that plastic surgeon's

> and the MSMA's characterization of the DOH materials as being old or

> outdated is absurd. " There's a brand-new 2000 one. My comment across the

> board is " it's like letting the fox in the hen house. They don't even

> know their own information, " she said.

>

>

>

> ston, who calls herself a breast implant survivor after having a

> ruptured breast implant removed in 1994, was a driving force in getting

> the informed consent bill passed into law. She is president and medical

> director of Toxic Discovery Network Inc., a nonprofit consumer protection

> organization that focuses on injuries resulting from saline and silicone

> breast implants.

>

> Beginning in 1997, ston worked with other women across the state in

> putting together a bill patterned after a land law. As the founder of

> Toxic Discovery Network and as a registered nurse, she came across a copy

> of the land bill. " I was just absolutely dumbfounded that there had

> been a state that had proceeded that gave informed consent specifically

on

> looking at breast implants, not only silicone, but saline. "

>

> The information supplied by the Food and Drug Administration to the

> Department of Health is a 67-page booklet titled Breast Implant

> Information Update. The booklet is up-to-date and unbiased, said

ston,

> who was asked to review it along with her medical research committee for

> the National Breast Implant Task Force. She said that it lets women know

> that the jury is still out on the correlation between breast implants and

> serious health problems.

>

> ston, along with five other supporters of the informed consent bill,

> testified in front of the Missouri Senate's Public Health and Welfare

> Committee in 1999 that women should be informed about health risks

> associated with breast implants. " Breast augmentation is not a

lifesaving

> procedure; it is an elective procedure and with that election comes the

> right of the patient to be truly informed of what harms can occur, "

> ston said in her testimony. " Patients are usually spoon fed what the

> physician believes they should know. In reality, these assumptions about

> medical care are not protective; instead, they deny the woman the right to

> make her own decision in a truly informed way. "

>

> Fuchs-sey, a Macon, Mo., woman who had two silicone breast

> implants removed in the 1990s, also testified in support of the informed

> consent bill. When she learned about the MSMA's lawsuit, she was outraged

> that any doctor would not uphold the oath to " first do no harm " by not

> giving patients information about risks associated with the procedure. If

> they say the materials are out-of-date, then isn't it their duty to make

> them up-to-date instead of getting rid of a law that aims to help

> patients? she asked. " This is not an acceptable way to practice

medicine, "

> she added.

>

> ston said that although the bill is a step in the right direction,

> she believes many doctors are not complying with the law. " If a doctor

> does not adhere to this, how do we slap his hand? There is nothing to

date

> that says how that is done, " said ston.

>

> The bill's sponsor in the Senate said he does not understand doctors'

> opposition to giving patients the information on the risks associated

with

> breast implants. " For some reason they didn't want to tell these

> patients what the risks were with the surgery, " said state Sen. Doyle

> Childers (R -s Spring). " If you're a doctor and all you've got to

> do is tell your patient what some of the risks are with a certain

> procedure, I don't see why they would oppose it. . . . A number of women

> were having a lot of medical problems with implants, and a number of them

> in their testimony in the committee . . . when we had the hearings said

> that they would not have had the surgery if they had known the risks

> associated with it, " said Childers, explaining the impetus behind the

> bill.

>

> Childers surmised that an effect of the bill may be more women choosing

> not to undergo the procedure, resulting in economic losses for doctors.

> " It probably has hit some people in the pocketbook pretty hard, " said

> Childers.

>

> Some supporters of the law said that the information provided by the FDA

> is just the tip of the iceberg on what information should be provided to

> patients. Plastic surgeons " show patients pictures of women who have

just

> gotten implants with & perfectly beautiful round breasts. They need to

see

> women that have had implants that have had problems with them and see the

> opposite side of the coin. Not everybody has perfectly round breast after

> surgery. There are umpteen problems that can happen to a woman with

breast

> implants. I think they deserve to see that because they could be one of

> those people in the future, " said Eileen Boserup, another woman who

> testified in support of the bill after having breast implants removed.

>

> Boserup, ston and Fuchs-sey said they will spend the time up

> until the case reaches the Supreme Court contacting politicians and

> legislators and letting them know of their support of the bill.

>

> Holste, spokesperson for the attorney general's office, said that

> the case before the Supreme Court will focus on the narrow

> constitutionality issue and not the specific components of the bill. The

> attorney general's office declined to comment further on the case.

>

> Missouri 's highest court will hear oral arguments on the case on

> Thursday, Feb. 1. Statewide radio network Missourinet will offer live

audio

> coverage on its Web site www.missourinet.com. Oral arguments begin at

> approximately 9 a.m. and conclude before noon.

>

>

>

> Brown

>

> The St. Louis Daily Record

>

> (314) 421-1880, ext. 223

>

>