Implant-Based Breast Reconstruction and Recurrent Cancer

Many women are fearful, for obvious reasons, that implants may contribute to cancer recurrence or may hinder detection of any recurrent cancer. Implant-based reconstruction is the most common type of breast reconstruction, even today. Recurrence of cancer is always a concern, and thus, studies were performed to evaluate if implants hindered or lengthened the time of diagnosis of recurrence.

The most notable study reviewed two groups of more than 300 women each - women with immediate breast reconstruction with implants and women without any reconstruction. These took into account patient age and stage of the disease. The recurrence rate of reconstructed patients = 6.8% and without reconstruction = 8.1%. There was no statistical difference in detection or recurrence between these groups. Nearly all (~95%) of all recurrences were detected by physical examination alone, with the rest being found via CT scan. Treatment was not affected by the implants. And, generally, did not require removal of the implant. Only 3 of the 21 women who had recurrence had her implant removed, with 2 of 3 requesting to have it removed.

Breast cancer continues to grow in number along with the reconstructive options available. With the growing knowledge of the reconstructive option, more and more women continue to opt for breast reconstruction. Only a few years ago, breast reconstruction was only conducted in approximately 10% of all women with breast cancer. This number has increased over the past few years alone, mostly due to the fact that women are more informed of this option. Overall, immediate breast reconstruction is still a safe procedure with numerous advantages...and as this study shows, has no impact on the identification of a recurrence or any association towards causing a cancer recurrence.

Recent Mammography Recommendations

Recently, the United States Preventive Services Task Force (USPSTF) has recently released recommendations for screening mammography for women. Their recommendations state that such mammograms should be every other year beginning at age 50yo, instead of the current guidelines of beginning at age 40yo (35yo for high-risk women). Mammography has unquestionably saved many lives, especially in women younger than 50yo. At least 10-20% of all breast cancers are diagnosed in these younger women. Breast cancer in younger women is always a more aggressive tumor, and overall, usually a more deadly tumor, especially when not caught early. When detected early and in its earliest and most treatable stage, the recurrence and survival rate is MUCH lower. Women over 74yo are not given specific guidelines for mammography, as they state that their risk of dying from other medical conditions is far greater than that of breast cancer, despite the fact that breast cancer (1 in every 8 women will develop) clearly increases with age.

The current recommendations by the USPSTF are based on old research from 1992-2001. The medical technology, especially in diagnostics, imaging (including digital mammography and breast MRI, breast cancer research (billions of dollars over the past few years alone, and treatment modalities have made huge advances, which accounts for the massive decrease in mortality rate over these past 8 years from the USPTF quoted studies. Regular mammographic screening began in 1990 - the mortality rate of breast cancer, previously unchanged over the past half century prior, has significantly decreased by mre than 30% since its inception. Clinical breast exams are not recommended prior to mammography, as they state that a clinical exam adds no additional benefit from that given by a mammogram. Lastly, this task force has not made any specific recommendation for monthly self-breast exams. As known, many breast tumors are found by women during self breast exams, prompting earlier medical evaluation, or by an experienced physician who may catch many masses not found by the woman.

The USPSTF has blatantly refused to data and research (and arguably, common sense), when these recommendations were made. No physician of the specialties that should have been involved (breast surgery, radiology, or oncology), had any input on theses recommendations. In fact, the American College of Radiology (ACR) and other Boards still stick to the current guidelines of beginning yearly screening mammograms beginning at age 40yo. Their claims of the "hazzards" of mammograms are unwarranted: discomfort, anxiety from false positives and need for possible surgery/treatment, and radiation exposure. Undoubtedly, a life saved from early detection far outweighs any of these concerns. Discomfort and anxiety is overshadowed by catching a breast cancer in its earliest stage. The radiation exposure from a mammogram is minimal. In fact, the radiation given off from the earth itself is much greater. The money saved by not performing mammograms between ages 40-49 will most likely be the opposite effect - with the more aggressive treatments, surgery, and battling of late-stage breast cancer will cost much more in money, time, and lives lost. This potential money savings in health care does not make sense as evidenced by current research and data/statistics in breast cancer research. My fear is that women that can afford to pay out-of-pocket for mammograms at an earlier age will get them and those who don't have these means will ultimately suffer. Saving women's lives and detecting/treating breast cancer at its earliest stages should be of utmost importance. The ACR still supports monthly self-breast exams, yearly physician breast exams, and annual screening mammograms beginning at age 40yo (age 35yo in high-risk women) - these are the best modalities that we have today.

Acellular dermal matrix - breast reconstruction applications

The use of the acellular dermal matrix has grown in its applications and use in plastic & reconstructive procedures, and growing. It has truly been a remarkable addition for breast reconstruction.

The acellular dermal matrix is a tissue that is specially-prepared, which comes from cadaveric skin. It has been processed in such a way that the basement membrane and cellular matrix remain intact, while removing all other cellular components that may lead to both rejection and infection. Packages as a sterile tissue product, due to its preparation, the chance of acquiring viruses and such is nearly absent.

Its applications for breast reconstruction alone include its use in tissue expander/implant reconstruction, to act as a "hammock" at the inferior portion of the breast for which the implant lies within. This creates a natural "sling" which mimics the ptosis (sag) of the breast, while supporting it in place. By suturing this matrix to its exact position of the breast margins, the plastic surgeon is able to precisely recreate an excellent contour for your breast, especially at the inferior, medial, and lateral positions. This also minimizes migration of the implant, as sometimes seen with "bottoming out" inferiorly or its displacement into the axilla (armpit). In addition to its increased aesthetic results, the acellular dermal matrix provides additional coverage over your implant. This is especially useful in those instances of dehiscence (your incision opening up), thus protecting the implant from exposure, and threatening its necessity for removal. Furthermore, in cases where the overlying mastectomy flaps are thin or damaged, leading to partial flap necrosis, the tissue matrix again provides a coverage over your implant, which can heal over time or a graft placed over the are or simply closed. Lastly, the additional coverage lessens implant visibility and palpability and is a great adjunct for revisionary breast surgery. The use of this matrix, along with the advantages listed above, has reduced the time of the reconstructive portion of the procedure as well. There is less pectoralis muscle retraction and eliminates the need to raise any other surrounding muscles in order to achieve complete implant coverage.

Additional benefits seen with the acellular dermal matrix are numerous. There has been a significantly decreased incidence (almost none) of capsular contracture around the implant at the area of the tissue matrix. Reasons are unknown as of yet, but contracture has been a huge problem in cases of implants used for reconstruction and augmentation. Also, there are tissue regeneration properties of the matrix in which rather than inciting a scarring response, the dermal matrix begins a regenerative process in which it acts as a biologic scaffold and unbelievably, vessels incorporate into matrix and the surrounding cells differentiate into surrounding tissue that it is incorporated into (an amazing concept).

Overall, the use of the acellular dermal matrix in breast reconstruction has been revolutionary. Its applications for tissue expander reconstruction, possibility to use in immediate implant reconstruction (going directly to implants rather than the use of a tissue expander first), revisionary breast surgery, capsular contracture complications, and nipple reconstruction have been great.

Perforator flaps/Microsurgery

Flap reconstruction offers an autologous (your own tissue) reconstruction, and gives many of the benefits described in earlier posts, such as a soft and "natural" breast mound. Such flaps also are much better for those with a history of radiation, or those who will ultimately require postoperative radiation therapy following mastectomy. Autologous tissue flaps for breast reconstruction offer the best options for these purposes, until the possibility of reconstruction with stem cells becomes a reality. The conventional autologous flap reconstruction requires sacrificing a muscle to reconstruct the breast, either the latissimus dorsi or rectus abdominis muscle. Although popular and reliable procedures to accomplish the goal of breast reconstruction, some of the expected outcomes that coincide are increased pain and seroma formation, along with functional deficits, weakness, and increased rates of hernias/bulges in the areas where the muscle was taken.

Perforator flaps have come to the forefront of plastic & reconstructive surgery due to their decreased morbidity, decreased recuperation time, and increased aesthetic results. This is due in part since they are muscle-sparing procedures, which subsequently maintain muscle function and do not have any morbidity associated with sacrificing of muscles, such as those described previously. Since these types of flaps are technically challenging and more complex, microsurgical expertise is required and as such, very few plastic surgeons in the United States are skilled enough to perform these perforator flaps successfully. In addition to the elaborate dissection of these flaps, albeit tedious, the flap must be reanastomosed under a microscope to blood vessels in the nearby recipient site.

Although a poplar procedure elsewhere in the world, patients in the U.S. often must travel far to find a surgeon capable of performing these perforator flaps, such as the DIEP, SIEA, SGAP, TUG, or ALT flap (DIEP - abdominal skin/tissue only; SIEA - abdominal skin/tissue only; SGAP - buttock skin/tissue only; TUG - groin skin/tissue only; ALT - lateral thigh skin/tissue only). These flaps spare muscle and are arguably the best reconstructive options that we have today. To find a surgeon near you who perform such free tissue transfer breast reconstructions, see the links provided to the right.

Breast reconstruction does not delay treatment for your cancer, if necessary, such as chemotherapy or radiation therapy. Literature shows no increase in recurrence rate or survival rate nor any decreased ability to diagnose such cancers. n fact, the most recent literature has even shown a decreased recurrence rate with immediate breast reconstruction. With all of this in mind, as well as knowing the the superior aesthetic results that are associated with immediate breast reconstruction (reconstruction performed at the same time as your mastectomy), I recommend discussing all of your breast reconstruction options with a plastic surgeon who specializes in breast reconstruction before your mastectomy procedure...please refer to my earliest posts on breast reconstructive options and understanding all of your options.

Part IV: Flap-based reconstruction - DIEP flap

DIEP flap

The use of microsurgery and perforator flaps, such as the DIEP flap, is the newest and state of the art technique for plastic & reconstructive surgery today, including breast reconstruction. Very few plastic surgeons perform this technique due to its complexity, time, and skill involved, but such reconstruction arguably provides the best aesthetic outcome with less morbidity, since only perforating vessels are utilized and muscle is not sacrificed for the flap reconstruction, for those women who are candidates for this unique procedure. However, it is a very popular technique elsewhere in the world and by those few surgeons who perform it in the United States. It is a procedure that has been refined through my fellowship training, and one in which women throughout the United States consult for to perform this innovative type of breast reconstruction, such as the DIEP flap.

Like the conventional TRAM flap procedure, the perforator flap DIEP breast reconstruction offers the advantages such as those offered by the TRAM flap, however, without the sacrifice of the rectus abdominis muscle - only the excess skin and fat from your lower abdominal wall is harvested for the flap...the muscle is left intact on your abdominal wall. This gives the distinct advantage of a completely autologous breast reconstruction, without need for an implant. In addition, since it is a muscle sparing procedure where the rectus abdominis muscle is not sacrificed, your abdominal wall integrity is maintained, leaving a much lower chance of bulges or hernias after the procedure than the TRAM flap.

The flap and its blood vessels are then disconnected entirely from the body, and the entire flap is then relocated to its new location in the breast area as a free tissue transfer. Its corresponding blood vessels are then reattached to blood vessels in the nearby area, using microsurgical techniques. Afterwards, the entire flap may be turned, twisted, or inset in the best position possible to contour a new breast for you. The conventional pedicled TRAM flap is limited in its insetting since it remains attached to its muscle insertion and blood supply superiorly.

Much like a tummy tuck, your abdominal incision will be sutured closed, first by repairing the abdominal wall, then by suturing your incision, leaving a single incision at the lower abdomen, hidden within your bikini line. To finish the closure, your umbilicus (belly button) will be brought out through a small incision, and sutured at its normal anatomic location.

General guidelines:

· Hospitalization: 5-7 days

· Advantages: Same as for the TRAM flap, but decreased hernia/bulge risk due to the fact that the muscle is spared and abdominal wall integrity maintained

· Disadvantages: Same as for the TRAM flap; complex procedure; abdominal wall integrity maintained (minimal hernia/bulge risk – much less than conventional TRAM flap)

October

Proud of the support and awareness of October as Breast Cancer Awareness Month!

Part III: Flap-based reconstruction - TRAM

TRAM flap (Transverse Rectus Abdominis Myocutaneous) flap

The excess skin, fat, and the rectus abdominis muscle are harvested from the lower abdominal wall. There are two (2) such muscles at the midline of your abdominal wall – one of them will be utilized for the reconstruction. This flap is then raised and tunneled under the upper abdominal skin and soft tissue, to its new location at the breast area. The flap is then trimmed, shaped, and secured into place, once a pleasing breast form is created, to recreate your breast.

The TRAM flap is a completely autologous (your own tissue) reconstruction. Autologous flaps will grow with you - as you gain or lose weight, and become a part of you. Flap-based reconstructions are almost alway preferable to implant-based reconstructions in patients with a history of radiation therapy. A TRAM flap usually provides enough tissue to recreate a breast, avoiding the use of an implant.

Much like a tummy tuck, your abdominal incision will be sutured closed, first by repairing the abdominal wall, then by suturing your incision, leaving a single incision at the lower abdomen, hidden within your bikini line. To finish the closure, your umbilicus (belly button will be brought out through a small incision, and sutured at its normal anatomic location.

General guidelines:

· Hospitalization: 3-5 days

· Advantages: Breast mound is present immediately; implant not needed - only your own tissue is used; your excess abdominal tissue is utilized; has a more natural appearance and feel of a breast

· Disadvantages: Flap complications; slightly weakened abdominal wall integrity; hernia/bulge risk; additional scar on the lower abdomen

Next...microsurgical free tissue transfers (e.g., DIEP, SIEA, GAP, etc.). This new technique for breast reconstruction will be discussed.

Part II: Flap-based reconstruction - latissimus dorsi

The excess skin, fat, and the latissimus dorsi muscle are harvested from the upper back. This flap is then tunneled under your axilla (armpit) to its new location at the breast area, with its blood vessels attached. The flap is then trimmed, shaped, and secured into place, once we have created a pleasing breast form, to recreate your breast. A tissue expander/implant may be added for additional volume, if needed, to increase the size of the reconstructed breast(s). Your back incision will be sutured closed, leaving a single incision along your back, often being hidden within your bra line.

A unique method of latissimus flap reconstruction that I have learned from one of the world experts in this type of breast reconstruction and which we now perform is the “volume-added” latissimus flap. This adds additional soft tissue when harvesting the latissimus dorsi muscle, increasing the amount of tissue that we use to reconstruct your breast(s). We have seen that using this type of latissimus flap reconstruction provides a more natural-appearing reconstructed breast, due to its additional volume, which optimizes the final aesthetic outcome. In some instances, a “volume-added” latissimus flap reconstruction may avoid using a tissue expander/implant, as this flap may provide adequate volume alone.

In addition, we have seen some excellent results from fat grafting procedures to augment the reconstructed breast. By simply performing some liposuction to harvest fat from unwanted areas of fat elsewhere on your body (e.g., abdomen, thighs, buttocks, etc.), we augment your breast to add additional volume or correct contour deformities. Fat grafting procedures are safe and also avoid the use of implants for the purpose of adding additional volume and create a breast of completely your own tissue. (The fat grafting procedure will be discussed in a separate post). This adjunct procedure is used to augment the volume of the breast, and may avoid the need for an implant - giving you a completely autologous reconstruction.

General guidelines:

· Hospitalization: 2-4 days

· Advantages: Breast mound is present immediately; your own tissue is used

· Disadvantages: Flap complications; minor loss of shoulder range of motion (alleviated with exercise); additional scar on the back; may need implant if additional volume is needed

Insurance Coverage - State Laws

Insurance Coverage is Required for Post-Mastectomy Breast Reconstruction if Mastectomy is Covered.

Alaska: enacted in 2000; conforms state law to the federal standards. The bill directly refers to the specific federal requirement: (A health care insurer that offers, issues for delivery, delivers, or renews in this state a health care insurance plan providing medical and surgical benefits for mastectomies shall comply with 42 U.S.C. 300gg-6 and 42 U.S.C. 300gg-52 regarding coverage for reconstructive surgery following mastectomies).

Arizona: enacted in 2000; conforms state law to the federal standards. The bill directly refers to the specific federal requirement: (A health care insurer that offers, issues for delivery, delivers, or renews in this state a health care insurance plan providing medical and surgical benefits for mastectomies shall comply with 42 U.S.C. 300gg-6 and 42 U.S.C. 300gg-52 regarding coverage for reconstructive surgery following mastectomies).

Arkansas: enacted in 1997; covers prosthetic devices and reconstructive surgery.

California: enacted in 1978; covers prosthetic devices or reconstructive surgery incident to mastectomy, including restoring symmetry; law was amended in 1991 to include coverage for pre-1980 mastectomies.

Connecticut: enacted in 1987; covers at least a yearly benefit of $500 for reconstructive surgery, $300 for prosthesis, and $300 for surgical removal of each breast due to tumor.

Delaware: enacted 2001; covers all stages of breast reconstruction including surgery and reconstruction of the opposite breast to produce symmetry; includes language stating surgery shall be provided in a manner determined in consultation with the attending physician.

Florida: enacted in 1987; covers initial prosthetic device and reconstructive surgery incident to mastectomy; 1997 amendment states that the surgery must be in a manner chosen by the treating physician, and surgery to reestablish symmetry is covered.

Illinois: initially enacted in 1980; covers initial prosthetic device and reconstructive surgery incident to post-1981 mastectomies. New bill enacted 2001 brings state into Federal compliance with federal requirements of the 1998 Womens' Health and Cancer Rights Act

Indiana: enacted in 1997; covers prosthetic devices and all stages of reconstructive surgery, in the manner determined by the attending physician and patient, including reconstruction of the other breast to produce symmetry. Additional legislation enacted in 2002 requires coverage for post-mastectomy services regardless of whether the individual was covered under the policy at the time of the mastectomy.

Kansas: enacted in 1999; covers breast reconstruction, including surgery of the other breast to produce a symmetrical appearance, prostheses and physical complications, in a manner determined in consultation with the attending physician and the patient.

Kentucky: enacted in 1998; covers all stages of breast reconstruction surgery following a mastectomy that resulted from breast cancer. 2002 amendment conforms statute to federal law

Louisiana: enacted in 1997; covers reconstructive surgery following a mastectomy, including reconstruction of the other breast to produce a symmetrical appearance, as agreed by the patient and attending physician. 1999 amendment conforms statute to federal law.

Maine: enacted in 1995; covers both breast on which surgery was performed and the other breast if patient elects reconstruction, in the manner chosen by the patient and physician.

Maryland: enacted in 1996; requires coverage for reconstructive surgery resulting from a mastectomy, including surgery performed on a non-diseased breast to establish symmetry.

Michigan: enacted in 1989; covers breast cancer rehabilitative services, delivered on an inpatient or outpatient basis, including reconstructive plastic surgery and physical therapy.

Minnesota: enacted in 1980; covers all reconstructive surgery incidental to or following injury, sickness or other diseases of the involved part, or congenital defect for a child. Additional legislation enacted in April 2002 expands language to specifically include benefits for all stages of reconstruction following mastectomy consistent with federal law. Also specifies that limitations on reconstructive surgery do not apply to reconstructive breast surgery following medically necessary mastectomy.

Missouri: enacted in 1997; covers prosthetic devices and reconstructive surgery necessary to achieve symmetry, as recommended by the oncologist or primary care physician.

Montana: enacted in 1997; covers reconstructive surgery following a mastectomy resulting from breast cancer, including all stages of one reconstructive surgery on the non-diseased breast to establish symmetry, and costs of any prostheses.

Nebraska: enacted in March 2000; follows the example of the federal statute by requiring coverage for medical and surgical benefits for mastectomy and for all stages of reconstruction of the breast after a mastectomy has been performed and reconstruction of the other breast to produce a symmetrical appearance. The measure also requires coverage for prostheses and physical complications of mastectomy.

Nevada: enacted in 1983; covers at least two prosthetic devices and reconstructive surgery incident to mastectomy. The law was amended in 1989 to cover surgery to reestablish symmetry.

New Hampshire: enacted in 1997; covers breast reconstruction, including surgery and reconstruction of the other breast to produce a symmetrical appearance, in the manner chosen by the patient and physician.

New Jersey: enacted in 1985; covers reconstructive breast surgery, including cost of prostheses. The law was amended in 1997 to extend coverage to reconstructive surgery to achieve and restore symmetry.

New York: enacted in 1997: covers breast reconstruction following mastectomy, including reconstruction on a healthy breast required to achieve reasonable symmetry, in the manner determined by the attending physician and the patient to be appropriate.

N. Carolina: enacted in 1997; covers for reconstructive breast surgery, including all stages and revisions of surgery performed on a non-diseased breast to establish symmetry, and reconstruction of the nipple/areolar complex without regard to the lapse of time between mastectomy and reconstruction. (1999 amendment conforms statute to federal law: Not Carried Over to 1999 General Assembly Second Session.)

N. Dakota: enacted 2001; specifies that health insurance policies may not be issued or renewed in the state unless they provide the benefit provisions of the 1998 Federal Womens' Health and Cancer Rights Act.

Oklahoma: enacted in 1997; covers reconstructive breast surgery performed as a result of a partial or total mastectomy, including all stages of reconstructive surgery performed within 2 years on a non-diseased breast to establish symmetry.

Pennsylvania: enacted in 1997; covers prosthetic devices and breast reconstruction, including surgery on the opposite breast to achieve symmetry, within six years of the mastectomy date. Additional legislation enacted 2002 adds language consistent with federal law.

Rhode Island: enacted in 1996; covers prosthetic devices and reconstructive surgery to restore and achieve symmetry incident to a mastectomy. Surgery must be performed within 18 months of the original mastectomy.

S. Carolina: enacted in 1998; covers prosthetic devices and breast reconstruction, including the non-diseased breast, if determined medically necessary by the patient and attending physician with the approval of the insurer.

Tennessee: enacted in 1997; covers all stages of reconstruction for the diseased breast, excluding lumpectomy, and procedures to restore and achieve symmetry between the breasts, in the manner chosen by the patient and physician, within 5 years of the reconstructive surgery on the diseased breast.

Texas: enacted in 1997; covers reconstruction of the breast incident to mastectomy, including procedures to restore and achieve symmetry, for contracts delivered, issued for delivery or renewed on or after Jan. 1, 1998. 1999 amendment conforms statute to federal law.

Utah: enacted in 2000; follows the example of the federal statute by requiring coverage for medical and surgical benefits for mastectomy and for all stages of reconstruction of the breast after a mastectomy has been performed and reconstruction of the other breast to produce a symmetrical appearance. The measure also requires coverage for prostheses and physical complications of mastectomy.

Virginia: enacted in 1998; covers reconstructive breast surgery performed coincident with a mastectomy performed for breast cancer or following the mastectomy, and surgery performed to reestablish symmetry between the two breasts.

Washington: enacted in 1985; covers reconstructive breast surgery if mastectomy resulted from disease, illness or injury. The law was amended in 1996 to include surgery to reestablish symmetry.

West Virginia: Enacted 2002, includes coverage for reconstruction of the breast on which mastectomy was performed and the opposite breast for symmetry; also provides coverage for prosthesis and complications all as determined in consultation with attending physician and patient.

Wisconsin: enacted in 1997; covers breast reconstruction of the affected tissue incident to mastectomy and specifies that such surgery is not considered cosmetic.

1998 Federal Breast Reconstruction Law

Following is the 1998 Federal Breast Reconstruction Law: Signed into Law on October 21, 1998 - ASPS is working with federal regulators as they draft guidance on implementation of the new law.

SEC. 713. REQUIRED COVERAGE FOR RECONSTRUCTIVE SURGERY FOLLOWING MASTECTOMIES.

(a) IN GENERAL.-A group health plan, and a health insurance issuer providing health insurance coverage in connection with a group health plan, that provides medical and surgical benefits with respect to a mastectomy shall provide, in a case of a participant or beneficiary who is receiving benefits in connection with a mastectomy and who elects breast reconstruction in connection with such mastectomy, coverage for:

(1) reconstruction of the breast on which the mastectomy has been performed;

(2) surgery and reconstruction of the other breast to produce a symmetrical appearance; and

(3) prostheses and physical complications all stages of mastectomy, including lymphedemas; in a manner determined in consultation with the attending physician and the patient. Such coverage may be subject to annual deductibles and coinsurance provisions as may be deemed appropriate and as are consistent with those established for other benefits under the plan or coverage. Written notice of the availability of such coverage shall be delivered to the participant upon enrollment and annually thereafter.

(b) NOTICE.-A group health plan, and a health insurance issuer providing health insurance coverage in connection with a group health plan shall provide notice to each participant and beneficiary under such plan regarding the coverage required by this section in accordance 1078 with regulations promulgated by the Secretary. Such notice shall be in writing and prominently positioned in any literature or correspondence made available or distributed by the plan or issuer and shall be transmitted:

(1) in the next mailing made by the plan or issuer to the participant or beneficiary;

(2) as part of any yearly informational packet sent to the participant or beneficiary; or

(3) not later than January 1, 1999; whichever is earlier.

(c) PROHIBITIONS.-A group health plan, and a health insurance issuer offering group health insurance coverage in connection with a group health plan, may not:

(1) deny to a patient eligibility, or continued eligibility, to enroll or to renew coverage under the terms of the plan, solely for the purpose of avoiding the requirements of this section; and

(2) penalize or otherwise reduce or limit the reimbursement of an attending provider, or provide incentives (monetary or otherwise) to an attending provider, to induce such provider to provide care to an individual participant or beneficiary in a manner inconsistent with this section. 1079

(d) RULE OF CONSTRUCTION.-Nothing in this section shall be construed to prevent a group health plan or a health insurance issuer offering group health insurance coverage from negotiating the level and type of reimbursement with a provider for care provided in accordance with this section.

(e) PREEMPTION, RELATION TO STATE LAWS:

(1) IN GENERAL.-Nothing in this section shall be construed to preempt any State law in effect on the date of enactment of this section with respect to health insurance coverage that requires coverage of at least the coverage of reconstructive breast surgery otherwise required under this section.

(2) ERISA.-Nothing in this section shall be construed to affect or modify the provisions of section 514 with respect to group health plans.''

(f) CLERICAL AMENDMENT.-The table of contents in section 1 of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1001 note) is amended by inserting after the item relating to section 712 the following new item:

SEC. 713. REQUIRED COVERAGE RECONSTRUCTIVE SURGERY FOLLOWING MASTECTOMIES.

(a) EFFECTIVE DATES.-

(1) IN GENERAL.-The amendments made by this section shall apply with respect to plan years beginning on or after the date of enactment of this Act. 1080

(2) SPECIAL RULE FOR COLLECTIVE BARGAINING AGREEMENTS.-In the case of a group health plan maintained pursuant to 1 or more collective bargaining agreements between employee representatives and 1 or more employers, any plan amendment made pursuant to a collective bargaining agreement relating to the plan which amends the plan solely to conform to any requirement added by this section shall not be treated as a termination of such collective bargaining agreement.

SEC. 903. AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT.

(a) GROUP MARKET.-Subpart 2 of part A of title XXVII of the Public Health Service Act (42 U.S.C. 300gg-4 et seq.) is amended by adding at the end the following new section:

SEC. 2706. REQUIRED COVERAGE FOR RECONSTRUCTIVE SURGERY FOLLOWING MASTECTOMIES.

(a) ''The provisions of section 713 of the Employee Retirement Income Security Act of 1974 shall apply to group health plans, and health insurance issuers providing health insurance coverage in connection with group health plans, as if included in this subpart.''.

(b) INDIVIDUAL MARKET.-Subpart 3 of part B of title XXVII of the Public Health Service Act (42 U.S.C. 1081 300gg-51 et seq.) is amended by adding at the end the following new section: ''SEC. 2752. REQUIRED COVERAGE FOR RECONSTRUCTIVE SURGERY FOLLOWING MASTECTOMIES. ''The provisions of section 2706 shall apply to health insurance coverage offered by a health insurance issuer in the individual market in the same manner as they apply to health insurance coverage offered by a health insurance issuer in connection with a group health plan in the small or large group market.''.

(c) EFFECTIVE DATES.-

(1) GROUP PLANS.-

(A) IN GENERAL.-The amendment made by subsection (a) shall apply to group health plans for plan years beginning on or after the date of enactment of this Act.

(B) SPECIAL RULE FOR COLLECTIVE BARGAINING AGREEMENTS.-In the case of a group health plan maintained pursuant to 1 or more collective bargaining agreements between employee representatives and 1 or more employers, any plan amendment made pursuant to a collective bargaining agreement relating to the plan which amends the plan solely to conform to any requirement added by the amendment made by 1082 subsection (a) shall not be treated as a termination of such collective bargaining agreement.

(2) INDIVIDUAL PLANS.-The amendment made by subsection (b) shall apply with respect to health insurance coverage offered, sold, issued, renewed, in effect, or operated in the individual market on or after the date of enactment of this Act

Is Breast Reconstruction Covered?

I've been asked to comment on the insurance coverage for breast reconstruction. The following posts will detail the following laws on this issue. On October 21, 1998, the Women's Health and Cancer Rights Act of 1998, became effective as part of the 1999 Omnibus Consolidated and Emergency Supplemental Appropriation Act. This new federal law requires group health plans and individual health policies that provide coverage for mastectomies to also provide coverage for breast reconstruction in connection with mastectomy.

In accordance with the Women's Health and Cancer Rights Act of 1998, members receiving mastectomy-related services are entitled to the following benefits:

• Reconstruction of the breast on which mastectomy has been performed
• Surgery and reconstruction of the other breast to produce a symmetrical appearance
• Prostheses and treatment of physical complications at all stages of the mastectomy, including lymphedemas
• One home health care visit within 48 hours of hospital discharge
• Outpatient care following a mastectomy performed in a health care facility
• Inpatient skilled nursing facility care in which the length of stay is determined by the treating physician based upon generally accepted criteria for safe discharge

This coverage will be provided in a manner determined in consultation with the attending physician and patient. These benefits are subject to and deductible or coinsurance requirements that may apply to your coverage.

Part I: Implant-based reconstruction - tissue expander/implant

A multi-part discussion on the various types of breast reconstructive procedures will be done in the following posts. Each has their own advantages and disadvantages. My hopes will be to thoroughly inform you of the different options and help you decide, along with your plastic surgeon's factoring in of your medical condition and your disease, which of these options would be most suitable for you.

The first part will discuss tissue expander/implant reconstruction...

IMPLANT-BASED RECONSTRUCTION:

Tissue expander / implant

A balloon-like expander is placed under the skin and pectoralis major muscle at the initial procedure. The expander is then slowly filled with saline water over several weeks until the desired breast size is achieved. It is then slightly over-filled, so that adequate skin and soft tissue is available when the tissue expander is exchanged for the permanent implant (either silicone or saline, depending on your preference). This exchange is performed at a separate procedure several weeks after the final volume in the expander is attained. ( Silicone vs. saline implants will also be discusses in a separate post).

As an innovative technique, an acellular dermal matrix may be used as a “sling” or “hammock” for which the expander or implant lies within the lower portion of the breast. In my experience, I have been able to set the margins of your breast perfectly and recreate the natural slope and ptosis (sag) of a normal breast. I have seen that this creates a more aesthetically pleasing breast contour and also adds additional volume and soft tissue coverage over your implant, thus decreasing many of the implant-based complications, such as malposition, capsular contracture, and extrusion.

The acellular dermal matrix has made dramatic advancements in plastic surgery. Especially in breast surgery and breast reconstruction, the dermal matrix has shown excellent aesthetic results, along with much fewer complications. Notably, this dermal matrix has had minimal, if any capsule formation. Also, it provides additional soft tissue between the overlying skin and the underlying implant. Current literature has shown some dramatic results and its popularity, and uses, continues to grow. As such, I will discuss the acellular dermal matrix in a separate posting to discuss it fully.

For some women who are candidates, another new technique that may be offered is immediate implant reconstruction. On certain circumstances, your surgeon may be able to perform a one-stage reconstruction, placing permanent implants at your initial procedure, without the need for a tissue expander. This will spare you from the tissue expander procedure, the subsequent tissue expansions, and the permanent implant exchange in the future. Discuss this option with your plastic surgeon if you are interested.

General guidelines:

Hospitalization: 1-2 days

Advantages: Less pain; no additional scars besides that of the mastectomy; least recuperation time

Disadvantages: May require additional procedures in the future; implant complications (e.g., rupture, contracture, malposition, etc.)

Types of Breast Reconstructive Procedures:

Breast Reconstructive Procedures:

There are two basic categories for reconstructive procedures used to recreate a breast:

· Implant-based: permanent silicone or saline implants are utilized to recreate a breast mound

o Breast implants are a great option for breast reconstruction and can achieve an excellent result in certain candidates

· Flap-based: your own tissue along with its blood supply from one area of your body is transferred to your breast area to recreate a breast

Utilizing a flap for reconstruction gives the benefit of using your own tissue for reconstruction of a breast. A flap often looks, feels, and moves more naturally than an implant alone. Most importantly, the flap also provides an added advantage of bringing in healthy, well-vascularized tissue to the breast area, which is beneficial for irradiated or compromised areas at the mastectomy defect. Flaps ameliorate some of the healing issues before or after radiation therapy by incorporating a remote source of blood flow, thus avoiding some of the potential complications with implant-based reconstruction.

The next posts will discuss the pros and cons of each of the above procedures as well as a thorough discussion describing the advantages and disadvantages of the above, including timing, effect on recurrence rates, surveillance, etc.