Date: Thu, 25 Jan 2001 14:31:53 -0800

~~~ thanx KKJ ~~~ 

Missouri Doctors Challenge Breast Implant Informed Consent Law

The St. Louis Daily Record

Jan. 22, 2001

By Lisa R. Brown - Staff Writer 

In the midst of a nation wide 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 The information that they are required to give patients is out-of-date and inaccurate, said plastic surgeon Dr. William 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surgeons across the state began receiving the Department of Health materials and _many found them to be inaccurate, out-of-date, and contradictory to the information already being provided to breast implant patients.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. Keithley Johnston 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. 

Johnston, 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, Johnston worked with other women across the state in putting together a bill patterned after a Maryland law. As the founder of Toxic Discovery Network and as a registered nurse, she came across a copy of the Maryland 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 Johnston, 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. 

Johnston, 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, Johnston 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.  

Cindy Fuchs-Morrissey, 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. 

Johnston 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 Johnston. 

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 Reeds 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, Johnston and Fuchs-Morrissey 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. 

Scott 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. 

Lisa Brown 

The St. Louis Daily Record 

(314) 421-1880, ext. 223