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The FDA has approved silicone breast implants (Inamed and MemoryGel) for breast reconstruction in women of all ages and for breast augmentation in those aged 22 years and older.

November 30, 2006 — The US Food and Drug Administration (FDA) has removed a 20-year ban on silicone breast implants and approved implants made by 2 companies for breast reconstruction in women of all ages and for breast augmentation in those aged 22 years and older.

Silicone Breast Implants (Inamed and MemoryGel) for Breast Augmentation and Reconstruction

On November 17, the FDA approved silicone-gel breast implants (Inamed, made by Allergan, Corp [formerly Inamed Corp] and MemoryGel Moderate Profile, Moderate Plus Profile, and Textured Surface Round, made by Mentor Corp) for the purposes of breast augmentation in women aged 22 years and older and for breast reconstruction in women of any age.

Breast augmentation includes primary implantation to increase breast size, and breast reconstruction involves replacement of breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to severe breast abnormality. Both procedures may require revision surgery to correct or improve results.

Although silicone implants were first marketed in 1962 prior to the FDA establishing requirements for device safety and efficacy, they were withdrawn in 1992 amid concerns regarding the risk for rupture and potential links to cancer and connective tissue diseases, such as lupus, scleroderma, and rheumatoid arthritis.

According to the FDA, a number of independent studies conducted during the last decade (including a report from the Institute of Medicine) have concluded that there is no convincing evidence that breast implants are linked to these conditions.

However, a rigorous review of clinical data from company-sponsored (core) studies has revealed risks for certain adverse events, such as hardening of the area around the implant, breast pain, change in nipple sensation, implant rupture, and the need for additional surgery. Despite these risks, most women have reported satisfaction with their implants. In core studies, women with Inamed (n = 420) and MemoryGel implants (n = 715) were followed up for 3 and 4 years, respectively.

As part of the approval process, the FDA also considered reviews by independent scientific bodies and deliberations of advisory panels composed of outside experts that heard public comment from hundreds of stakeholders. In addition, each company's manufacturing facilities were inspected to ensure compliance with the agency's Good Manufacturing Practices.

Nevertheless, the approvals require each company to continue its core study for 10 years and also to conduct a large postapproval study of 40,000 women followed up for a 10-year period. The postmarketing studies will be used to collect information from implant recipients regarding the prevalence of local complications, connective tissue disease and its signs/symptoms, rates of cancer and suicide, potential effects on reproduction and lactation, potential interference of implants with mammography, compliance with magnetic resonance imaging (MRI) requirements, and implant rupture rates.

Further conditions for approval also included focus group studies of patient labeling, continuation of laboratory studies to further characterize types of device failure, and device tracking to ensure future communication of product updates if needed.

Also, clinicians must complete a certification program to access and order the implants. These programs are intended to ensure clinician review of the new product labeling and clinical study data, surgical techniques, and information regarding patient education and device-tracking requirements. The FDA warns that breast implants are not considered to be lifetime devices. Women considering breast implants should be counseled regarding the high likelihood of at least one additional surgery during their lifetime due to implant rupture, other complications, or unacceptable cosmetic outcomes.

Explantation without replacement may lead to irreversible changes in the breast, and revision surgery is associated with an increased risk for future complications relative to primary implantation or reconstruction surgery. Implant shell integrity can be compromised during reoperation, leading to device failure.

On implantation, women should be advised to perform monthly breast self-examinations and shown how to distinguish the implant from their breast tissue. The implant should not be manipulated or squeezed excessively. Lumps, persistent pain, swelling, hardening, or change in implant shape may be symptomatic of rupture and may require MRI evaluation.

Women with breast implants should have their first MRI 3 years after the initial implant surgery and every 2 years thereafter because of the increased sensitivity of the MRI for the diagnosis of rupture. The FDA notes that the cost of MRI screening during a woman's lifetime may exceed the cost of initial surgery and may not be covered by medical insurance.

If a rupture occurs, the gel may remain within the scar tissue capsule surrounding the implant (intracapsular rupture), move outside the capsule (extracapsular rupture), or potentially migrate throughout the body. Explantation (with/without replacement) is indicated if signs of rupture occur, such as subcapsular lines, characteristic folded wavy lines, and teardrop, keyhole, or noose signs.

In the Inamed core study, implant rupture rates in MRI-assessed patients were 2.7% for primary augmentation, 4.0% for revision augmentation, 0% for primary reconstruction, and 0% for revision reconstruction. Corresponding rates in the MemoryGel study were 0.5%, 7.7%, 0.9%, and 0%, respectively.

The FDA notes that current recommendations for preoperative and screening mammograms are applicable to women with breast implants. Because MRI interpretation can be complicated by obscuration of underlying breast tissue and/or compression of overlying tissue, mammographers should be notified regarding implant type and placement.

Women who are considering becoming pregnant should be advised that breast implant surgery may interfere with breast-feeding by either reducing or eliminating milk production. Also, smokers should be warned of the potential associated interference of smoking with the healing process after implantation or any other subsequent surgeries required.

All patients should be advised that healthcare insurance premiums may increase, insurance coverage may be dropped, and/or future coverage denied based on the presence of breast implants. In addition, insurance may not cover treatment of complications.

The silicone breast implants were granted conditional approval by Health Canada on October 21, 2006, with postmarketing requirements similar to that imposed by the FDA. In other countries worldwide, more than 379,000 Inamed implants were distributed from 1998 to 2005. The number of MemoryGel devices implanted during 1992 to 2005 has exceeded 750,000. According to the FDA, the devices have not been withdrawn from any international market because of safety and efficacy concerns.

Learning Objectives for This Educational Activity

Upon completion of this activity, participants will be able to:

Describe potential adverse events related to use of silicone breast implants.

Identify safety considerations for patients receiving silicone breast implants.

Explain FDA requirements for clinicians wishing to obtain the devices for implantation.

Pearls for Practice

The FDA has approved silicone breast implants for breast reconstruction in women of all ages and for breast augmentation in those aged 22 years and older. In clinical studies, the devices were linked to risks for hardening of the area around the implant, breast pain, changed nipple sensation, implant rupture, and requirements for additional surgery. Patients should be warned that breast implants are not considered to be lifetime devices and that the likelihood for at least 1 additional surgery due to implant rupture, other complications, or unacceptable cosmetic outcomes is high.

Because MRI is a sensitive diagnostic method for diagnosing rupture, women with breast implants should have their first MRI 3 years after the initial implant surgery and every 2 years thereafter. Ruptured implants should be removed; however, explantation only may cause irreversible breast changes, and replacement is linked to an increased risk for future complications. Current recommendations for preoperative and screening mammograms remain applicable, and mammographers should be informed regarding implant type and placement. Women considering pregnancy should be advised that breast implant surgery can interfere with breast-feeding. Smokers should be warned of the potential associated interference of smoking with the healing process after implantation or any other subsequent surgeries required. All patients should be advised to consult with their health insurance companies regarding current/future medical coverage and coverage for complications.

To access and order the implants, clinicians must complete a certification program. The programs are intended to review the new product labeling and clinical data, surgical techniques, and information regarding FDA requirements for patient education and device tracking.