HB 37: "An Act relating to silicone implants; and providing for an effective date."
00HOUSE BILL NO. 37 01 "An Act relating to silicone implants; and providing for an effective date." 02 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF ALASKA: 03 * Section 1. AS 08.64 is amended by adding new sections to article 3 to read: 04 Sec. 08.64.363. REMOVAL OF BREAST IMPLANT. A physician who 05 removes a breast implant shall send the breast implant to a laboratory for testing that 06 is approved by the Department of Health and Social Services. The laboratory shall 07 send the results of its test to the physician and to the department. The results are 08 confidential information, not subject to inspection or copying under AS 09.25.110 - 09 09.25.120. 10 Sec. 08.64.364. PROHIBITION AGAINST SILICONE BREAST 11 IMPLANTATION. A physician may not operate on a patient to insert a breast implant. 12 In this section, "breast implant" means a surgically inserted pocket or envelope under 13 the skin that consists of soft silicone gel, a combination of soft silicone gel and saline 14 solution, or silicone covered by polyurethane foam.
01 * Sec. 2. AS 08.64.364 is repealed and reenacted to read: 02 Sec. 08.64.364. BREAST IMPLANTATIONS. The board shall adopt 03 regulations necessary to ensure that physicians licensed under this chapter are required 04 to clearly and fully inform a patient who is considering a breast implant about the 05 advantages, disadvantages, and risks associated with the procedures and materials 06 involved. The board shall consider the informed consent requirements adopted by the 07 federal Food and Drug Administration when developing the regulations required under 08 this subsection. The board's regulations must require that the physician and the patient 09 sign a form that attests that the patient has received the information required under the 10 board's regulations before the physician may perform a breast implantation procedure 11 on the patient. The signed form shall be retained by the physician in the patient's 12 medical file. In this section, "breast implant" means a surgically inserted pocket or 13 envelope under the skin that consists of soft silicone gel, a combination of soft silicone 14 gel and saline solution, or silicone covered by polyurethane foam. 15 * Sec. 3. AS 18.05 is amended by adding a new section to read: 16 Sec. 18.05.048. BREAST IMPLANT REMOVALS; REGISTRY; 17 REGULATIONS. (a) The department shall maintain a registry of the 18 (1) names of patients from whom breast implants are removed; 19 (2) names of the patient's children who were born after the patient 20 received a breast implant if the patient is a woman; and 21 (3) test results received under AS 08.64.363. 22 (b) The commissioner shall adopt regulations regarding removed breast 23 implants, including regulations 24 (1) establishing a procedure to ensure confidentiality of information 25 obtained by the department in carrying out this section; 26 (2) governing the delivery and storage of removed breast implants; 27 (3) setting requirements for laboratory procedures for the testing and 28 storage of removed breast implants; 29 (4) establishing the types of test that must be performed on removed 30 breast implants; 31 (5) governing the compilation, evaluation, and disclosure of the test
01 results; and 02 (6) establishing a system for testing and monitoring the health of 03 patients who have received breast implants, patients from whom breast implants have 04 been removed, and the children of both groups of patients. 05 (c) In this section, "breast implant" means a surgically inserted pocket or 06 envelope under the skin that consists of soft silicone gel, a combination of soft silicone 07 gel and saline solution, or silicone covered by polyurethane foam. 08 * Sec. 4. AS 21.09 is amended by adding a new section to read: 09 Sec. 21.09.202. INFORMATION ABOUT COVERAGE OF BREAST 10 IMPLANTS. (a) An insurer authorized under this chapter to offer, issue for delivery, 11 deliver, or renew a disability insurance policy in the state, or a hospital or medical 12 service corporation authorized under AS 21.87 to offer or renew a subscriber's contract 13 shall provide to the director the following information in a form and manner, including 14 frequency, determined by the director under regulations that the director may adopt to 15 implement this section: 16 (1) the coverage provided under the various plans of the insurer or 17 corporation for breast implant removals and breast implant-related conditions; and 18 (2) the provisions of the various plans of the insurer or corporation 19 regarding preexisting conditions for individuals with breast implants. 20 (b) Upon request of an individual, the director shall make available to the 21 individual the information received under (a) of this section. The director may include 22 a notice that the provision of the information does not mean that the director 23 guarantees the accuracy of the information. The director may set a fee to cover the 24 costs of providing information to an individual under this subsection. 25 (c) Failure to file the information required under (a) of this section is subject 26 to a civil penalty of $100 for each day the failure continues. 27 (d) In this section, "breast implant" means a surgically inserted pocket or 28 envelope under the skin that consists of soft silicone gel or saline solution, a 29 combination of soft silicone gel and saline solution, or silicone covered by 30 polyurethane foam. 31 * Sec. 5. TRANSITIONAL PROVISION. The first report required under AS 21.09.202(a),
01 enacted by sec. 4 of this Act, is due December 31, 1995. 02 * Sec. 6. Section 2 of this Act takes effect on the date the Food and Drug Administration 03 makes a final decision that confirms the safety and effectiveness of breast implants that 04 contain silicone. The commissioner of health and social services shall monitor the Food and 05 Drug Administration's activities in this area and immediately notify the revisor of statutes of 06 the date, if any, when the Food and Drug Administration makes the final decision described 07 in this section.