Breast Implants - Augmentation - Biotech, Pharma and Life Science Channel
Breast implants are medical devices that are used to augment breast size or to reconstruct the breast following mastectomy or to correct a congenital abnormality. Breast implants consist of a silicone outer shell and a filler (most commonly silicone gel or saline). Approximately 5 to10 million women worldwide have breast implants.
According to the American Society of Plastic Surgeons National Clearinghouse of Plastic Surgery Procedural Statistics, there were 296,203 breast augmentation procedures and 93,083 breast reconstruction procedures performed in the United States in 2010. Approximately half the procedures used saline-filled implants and half used silicone gel-filled implants.
Back in 2006, the FDA approved Allergan and Mentor silicone gel filled breast implants (as opposed to saline) for breast reconstructive surgery and for breast enlargement in women aged 22 and older. However, one in five women that receive silicone implants need to have these devices removed within 10 years due to complications, and as many as half of women who receive implants for reconstruction after breast surgery, will need them removed within the same time frame.
Silicone implants had been banned prior to 2006 because of concerns about possible links to several diseases, including cancer and lupus. Other common complications included hardening of the area around the implant and the need for additional surgeries and implant removal. The FDA also notes other frequent problems include implant rupture, wrinkling, breast asymmetry, scarring, pain and infection.
In mid 2011 the FDA updated their review on the Safety of Silicone Gel-Filled Breast Implants (2011) - Executive Summary
Summary of FDA Key Findings
- Based on the totality of the evidence, the FDA believes that silicone gel-filled breast implants have a reasonable assurance of safety and effectiveness when used as labeled. Despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use.
- The longer a woman has breast implants, the more likely she is to experience local complications or adverse outcomes. Women with breast implants will need to monitor their breasts for local complications for the rest of their lives.
- The most frequent complications and adverse outcomes experienced by breast implant patients include capsular contracture, reoperation, and implant removal (with or without replacement). Other frequent complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection, among others. These observations are consistent with the local complications and adverse outcomes that were known at the time of approval.
- Women with breast implants may have a very small but increased likelihood of being diagnosed with anaplastic large cell lymphoma.
- In the post-approval Core Studies, between 20 to 40 percent of augmentation patients and 40 to 70 percent of reconstruction patients had reoperations during the first 8 to 10 years after they received their implants. Although routine replacement is not necessary, many women will need additional surgery to modify, remove, or replace their implants.
- There is no apparent association between silicone gel-filled breast implants and connective tissue disease, breast cancer, or reproductive problems. Associations that are very rare or that take many years to manifest may not be detected using currently available data.
- MRI continues to be the most effective method of detecting silent (asymptomatic) rupture of silicone gel-filled breast implants.
- Interpretation of the data from the silicone gel-filled breast implant post-approval studies may be limited by low follow-up rates.
FDA Conclusion (June 2011)
Based on the totality of the evidence, the FDA believes that silicone gel-filled breast implants have a reasonable assurance of safety and effectiveness when used as labeled. Despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use. Manufacturers and physicians should continue to provide balanced and up-to-date information to women considering breast implants to help inform their decisions.
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Breast Augmentation with Silicone Implants
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Medical and Biotech [MESH] Definitions
Auditory Brain Stem Implants
Multi-channel hearing devices typically used for patients who have tumors on the COCHLEAR NERVE and are unable to benefit from COCHLEAR IMPLANTS after tumor surgery that severs the cochlear nerve. The device electrically stimulates the nerves of cochlea nucleus in the BRAIN STEM rather than the inner ear as in cochlear implants.
Auditory Brain Stem Implantation
Surgical insertion of an electronic hearing device (AUDITORY BRAIN STEM IMPLANTS) with electrodes to the cochlea nucleus in the BRAIN STEM rather than to the inner ear as in COCHLEAR IMPLANTATION.
Infant Formula
Liquid formulations for the nutrition of INFANTS, useful for those with special needs or MILK HYPERSENSITIVITY or those whose mothers are unable to breastfeed (BREAST FEEDING).
Mammary Glands, Human
Glandular tissue in the BREAST of human that is under the influence of hormones such as ESTROGENS; PROGESTINS; and PROLACTIN. In WOMEN, after PARTURITION, the mammary glands secrete milk (MILK, HUMAN) for the nourishment of the young.
Dental Etching
Preparation of TOOTH surfaces, and of materials bonded to teeth or DENTAL IMPLANTS, with agents and methods which roughen the surface to facilitate adhesion. Agents include phosphoric or other acids (ACID ETCHING, DENTAL) and methods include LASERS.
