Breast implants are medical devices that are implanted either under breast tissue or under the chest muscle for breast augmentation or reconstruction. There are two major types: saline-filled and silicone gel-filled. Saline-filled breast implants are silicone shells that are either prefilled or filled with saline during surgery, and some of these allow for adjustments of the filler volume after surgery. Silicone gel-filled breast implants are silicone shells prefilled with silicone gel. Breast implants vary in profile, size, and shell surface (smooth or textured).
FDA has approved four breast implants for marketing in the U.S.:
All breast implants other than these four approved devices are considered investigational devices, including the more-cohesive (“gummy bear”) implants. For a woman to receive an investigational breast implant in the U.S., she must enroll in a clinical study.
Breast implants are used for:
Mentor and Allergan (formerly Inamed) saline-filled breast implants are approved for: (1) reconstruction (primary reconstruction and revision-reconstruction) in women of any age and (2) augmentation (primary augmentation and revision-augmentation) in women 18 years or older.
Mentor and Allergan silicone gel-filled breast implants are approved for: (1) reconstruction (primary reconstruction and revision-reconstruction) in women of any age and (2) augmentation (primary augmentation and revision-augmentation) in women 22 years or older.
FDA restricts the marketing of breast implants for augmentation to women of a minium age because young women’s breasts continue to develop through their late teens and early 20s and because there is a concern that young women may not be mature enough to make an informed decision about the potential risks. However, there is there is no age restriction on the marketing of these products for reconstruction, so as to allow young women to have access to breast implants to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality.
As for devices that are not approved for marketing, there are various age criteria and other restrictions for women who receive breast implants as part of a clinical study. Contact one of the companies conducting a study for more information.
FDA approved saline-filled breast implants for augmentation in women ages 18 and older. FDA approved silicone gel-filled implants for women ages 22 and older. The age restrictions are different because the risks are different for the two products. For example, silicone gel-filled implants will require frequent MRI monitoring to detect silent rupture (a rupture that can go undetected by you or your doctor). There is no risk of silent rupture for saline-filled implants. In addition, the health consequences of a ruptured saline-filled breast implant are different from those of a ruptured silicone gel-filled breast implant.
There are several ongoing clinical studies (i.e., investigational device exemption (IDE) applications) of saline and silicone gel-filled breast implants. These studies include those for the more cohesive silicone gel-filled breast implants manufactured by Mentor and Allergan (formerly Inamed), as well as studies conducted by other manufacturers. These devices are still in research and have not been approved for marketing.
In addition, Mentor and Allergan will are conduct studies on patients who get silicone gel-filled breast implants after they are approved.
Information about participation in a clinical study can be obtained from the companies conducting the study.
Some of the risks of breast implants include:
Breast implants do not last forever. If you decide to get breast implants, you will likely need additional surgeries on your breasts over your lifetime due to rupture, other complications (for example, capsular contracture, breast pain), or unacceptable cosmetic outcomes (for example, asymmetry, unsatisfactory style/size, wrinkling/rippling).
We do not know all of the causes of breast implant rupture. We do know that breast implants can rupture from:
If your saline-filled breast implant ruptures, you or your doctor will be able to tell. When saline-filled breast implants rupture, they deflate and the saline solution leaks into your body immediately or over a period of days. You will notice that your implant loses its original size or shape.
If your silicone gel-filled breast implant ruptures, it is likely that neither you nor your doctor will know. This is known as a silent rupture. This is why MRI is recommended at three years after implantation and then every two years thereafter to screen for rupture. However, sometimes there are symptoms. These symptoms include hard knots or lumps surrounding the implant or in the armpit, change or loss of size or shape of the breast or implant, pain, tingling, swelling, numbness, burning, or hardening of the breast.
The patient labeling for the Mentor and Allergan (formerly Inamed) silicone gel-filled breast implants recommends removal of ruptured implants.
You and your doctor will need to decide whether or not to have a ruptured implant removed.
Platinum is a metal used in the manufacture of the shell and gel components of silicone breast implants. FDA fully evaluated the scientific literature on platinum. Based on the existing literature, FDA believes that the platinum contained in the implant shell and gel is in the zero oxidation state, which poses the lowest health risk. This is further supported by the available biocompatibility testing, gel bleed testing, and clinical data on these implants.
Some important factors to consider include:
Factors to consider specifically about silicone gel-filled breast implants include:
The so-called “gummy bear” implants are more cohesive silicone gel-filled breast implants made of a firmer silicone gel filler to help maintain the shape of the implant. At this time, these breast implants are available only through clinical studies being conducted by Mentor and Allergan (formerly Inamed).
If you have a problem related to your breast implants and you are part of a clinical study, then it is important that you report the problem to your doctor so he/she can treat you, as well as report the problem as part of the clinical study.
If you have a problem related to your breast implant and your breast implant has been approved for marketing, then you should report the problem to your doctor and ask your doctor to report the problem to FDA. You can also report your problem to FDA yourself through FDA’s MedWatch system or by calling 1-800-332-1088. When you or your doctor makes a report to MedWatch, t he information is entered into a database that FDA uses to monitor safety trends to determine if follow-up is needed. If you report the problem yourself to FDA, y ou will receive an acknowledgement from FDA after we receive your report. You will be personally contacted only if we need additional information. We recommend that you k eep a copy of the MedWatch form completed by you or your doctor for your records.
Individual reports are on FDA’s MedWatch website (www.fda.gov/medwatch). To access these reports, follow the links for: “Medical Device Reporting,” “Access to FDA Safety Data,” and “Manufacturer and User Facility Device Experience Database (MAUDE).”
Submissions under the Alternative Summary Reporting Program (ASR) can be obtained by following instructions under the Freedom of Information Act (FOI), available via access to the main FDA website (www.fda.gov). FOI requests can also be faxed to 301-443-1726 or mailed to: Food and Drug Administration, FOI Staff, HFI-35, 5600 Fishers Lane, Rockville, MD 20857.
Summary reporting is an alternative way of reporting to FDA for well known and well documented adverse events. It has been in effect for silicone gel-filled and saline-filled breast implants for many years. Summary reporting for these types of events promotes more efficient processing and analytic review for FDA and the companies.
On the other hand, companies are required to file individual MDR reports for any unexpected or unusual adverse events that may be related to breast implants. Deaths must always be reported individually.
FDA publishes guidance documents that describe FDA’s current thinking on a topic and contain recommendations for companies . Although guidance documents are often helpful to companies, they do not create legal requirements, and their recommendations do not bind or require a company to take any specific steps. Many guidance documents advise companies how to test their products. Other guidance documents describe how companies should prepare their applications and how FDA monitors products once they are on the market.
FDA issued a guidance document on breast implants called “Saline, Silicone Gel, and Alternative Breast Implants.” It describes the types of information that breast implant companies should submit to FDA when seeking approval of a breast implant so that we can assess whether or not there is a reasonable assurance that the device is safe and effective. The latest version of the breast implant guidance document was published in November 2006 and reflects information learned from two Advisory Panel meetings, over 50 comments on the 2004 draft version of the guidance document, and FDA’s review of two silicone gel-filled breast implant premarket approval applications (PMAs). This updated guidance is available at http://www.fda.gov/cdrh/ode/guidance/1239.pdf.
Scientific information in the PMAs demonstrated that there is a reasonable assurance that Allergan (formerly Inamed) and Mentor’s silicone gel-filled breast implants are safe and effective and that there is adequate information about these products to enable women to make informed decisions about whether to get them.
FDA’s decision was based on:
The Mentor and Allergan (formerly Inamed) implants were approved for:
In the Mentor and Allergan (formerly Inamed) Core Studies, the most frequent complication was reoperation (additional surgery). Capsular contracture was another frequent complication. Other frequent complications included implant removal, breast pain, nipple sensation changes, and asymmetry.
For both Core Studies, some women experienced more than one complication. In addition, the complication rates were typically higher for revision (reoperation) implants than for primary (first time) implants.
Rupture rate and consequences of rupture were characterized for each Core Study. Consequences of rupture include intracapsular rupture (when the gel remains within the scar tissue capsule surrounding the implant), extracapsular gel (when the gel moves outside the capsule but remains within the breast tissue), migrated gel (when the gel moves beyond the breast), and clinical consequences.
Rupture rate was assessed for patients who had scheduled MRIs to screen for non-symptomatic, or silent, rupture (the MRI cohort), as well as for those who did not have scheduled MRIs to screen for silent rupture (the non-MRI cohort).
It is important to note that FDA performed an extensive review of all available data, both clinical and preclinical, to characterize rupture rate and consequences of rupture (i.e., intracapsular rupture, extracapsular gel, migrated gel, and health consequences of rupture). The Core Study was not the only source of information used to characterize rupture. Please refer to the Summary of Safety and Effectiveness Data (SSED) for each company for more information (Mentor SSED and Allergan SSED)
FDA is requiring each company to do the following:
FDA intends to present an update on the status of the conditions of approval at public Advisory Panel meetings in five and 10 years, and at any other FDA decides is appropriate.
FDA determined that there were adequate data to support the approval of the Mentor and Allergan (formerly Inamed) products. Now that the products have been determined by FDA to be safe and effective, we will continue to monitor their safety and effectiveness by requiring each company to conduct a study of approximately 40,000 women through 10 years. The large post-approval studies will gather data on long-term local complications, connective tissue disease and its signs and symptoms, neurological disease and its signs and symptoms, reproductive issues, offspring issues, lactation issues, cancer, suicide, mammography issues, and MRI compliance and rupture results. FDA anticipates that data from these long-term studies will provide important information for patients and physicians and may lead to improvements in device labeling.
If the post-approval studies uncover any new risks or unexpected problems, FDA can pursue a range of regulatory options, as appropriate. For example, FDA could require the companies to change the patient and physician labeling, or contact all patients through the mandatory tracking program.
To assure that Mentor and Allergan (formerly Inamed) complete these studies, FDA will:
The Institute of Medicine (IOM) completed its independent review of past and ongoing scientific research of both silicone gel-filled and saline-filled breast implant safety in June 1999.1 Below are some of the major findings.
Potential local complications are shown alphabetically below. You may need non-surgical treatments or reoperations (including removal of your implant) to treat any of these. (See the Glossary in the Handbook for definitions.
Capsular contracture and rupture/deflation are the most common local complications that occur with both silicone gel-filled and saline-filled breast implants.
Capsular contracture occurs when the scar tissue or capsule that normally forms around the implant tightens and squeezes the implant. It can happen to one or both of the implants. There are four grades of capsular contracture known as Baker grades.
The Baker grading is as follows:
|Grade I||breast is normally soft and looks natural|
|Grade II||breast is a little firm but looks normal|
|Grade III||breast is firm and looks abnormal|
|Grade IV||breast is hard, painful, and looks abnormal|
Capsular contracture may require reoperation, usually for Grades III and IV, and it may occur again, sometimes even years following the implant surgery.
Breast implants do not last a lifetime. Some breast implants may rupture/deflate in the first few months after surgery and some after several years. Others may take 10 or more years to rupture/deflate.
The reasons for rupture are not well understood and are currently being studied. Some possible causes of rupture/deflation include:
When silicone gel-filled implants rupture, some women may notice decreased breast size, hard knots, uneven appearance of the breasts, pain or tenderness, tingling, swelling, numbness, burning, or changes in sensation. Other women may unknowingly experience a rupture without any symptoms (silent rupture).
Magnetic resonance imaging (MRI) with equipment specifically designed for imaging the breast may be used for evaluating patients with suspected rupture or leakage of their silicone gel-filled implant. Silicone gel may
Plastic surgeons usually recommend removal of the implant if it has ruptured, even if the silicone is still enclosed within the scar tissue capsule, because the silicone gel may eventually leak into surrounding tissues.
When saline-filled breast implants deflate, the saline solution leaks either through an unsealed or damaged valve or through a break in the implant shell. Implant deflation can be immediate or progress over a period of days, months, or years and is noticed by loss of size or shape of the implant. Additional surgery is needed to remove deflated implants.
It is likely that you will need to have one or more reoperations over the course of your life because of local complications from breast implants. Reasons for reoperations could include any of the potential local complications above. Multiple reoperations to either improve the appearance of the breasts, to remove ruptured/deflated implants, or both may result in an unsatisfactory cosmetic outcome.
One type of reoperation is the removal of the implant(s), with or without replacement. Removal involves surgery. You are likely to have your implant removed at some time over the course of your life because of one or more local complications above. Many women decide to have the implants replaced, but some women do not. Women who do not have their implants replaced may have cosmetically undesirable dimpling, puckering, or sagging of the breast following removal of the implant.
1 Safety of Silicone Breast Implants. Institute of Medicine National Academy Press, Washington, D.C. 2000. (IOM Report). Also available through IOM website at www.iom.edu/report.asp?id=5638