FDA FAQ Regarding Newly-Approved Silicone Breast Implants
1. What are breast implants?
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).
2. What types are approved by FDA?
FDA has approved four breast implants for marketing in the U.S.:
- In May 2000, Mentor and Allergan (formerly Inamed) received approval for saline-filled breast implants. These implants were approved for breast augmentation in women 18 years or older and for breast reconstruction in women of any age.
- In November 2006, Allergan and Mentor received approval for their silicone gel-filled breast implants. These implants were approved for breast augmentation in women 22 years or older and for breast reconstruction in women of any age.
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.
3. How are breast implants used?
Breast implants are used for:
- primary augmentation (to increase breast size for cosmetic reasons)
- revision-augmentation ( revision surgery to correct or improve the result of an original breast augmentation surgery)
- primary reconstruction (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)
- revision-reconstruction ( revision surgery to correct or improve the result of an original breast reconstruction surgery).
4. Are there any age limits with respect to who can get breast implants?
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.
5. Why is the age minimum different for augmentation for saline-filled and silicone gel-filled breast implants?
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.
6. Are clinical studies of breast implants still being conducted?
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.
7. What are the risks of breast implants?
Some of the risks of breast implants include:
- reoperations (additional surgeries), with or without removal of the device
- capsular contracture (hardening of the area around the implant)
- breast pain
- changes in nipple and breast sensation
- rupture with deflation for saline-filled implants
- rupture with or without symptoms for silicone gel-filled implants
- migration of silicone gel for silicone gel-filled breast implants.
8. How long do breast implants last?
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).
9. What causes breast implants to rupture?
We do not know all of the causes of breast implant rupture. We do know that breast implants can rupture from:
- damage during implantation or during other surgical procedures
- folding or wrinkling of the implant shell
- trauma or other excessive force to the chest
- compression of the breast during mammography.
10. How will I know if my breast implant has ruptured?
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.
11. What are some of the important factors I should consider when deciding whether or not to get breast implants?
Some important factors to consider 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 complications or unsatisfactory cosmetic outcomes.
- Many of the changes to your breasts following implantation cannot be undone. If you later choose to have your implants removed and not replaced, your breasts will not change back to the way they looked before your implant surgery. You may have permanent dimpling, puckering, wrinkling, or other cosmetic changes.
- When you have your implants replaced (revision), your risk of complications increases compared to your first (primary) surgery.
- Routine mammograms to screen for breast cancer will be more difficult with breast implants.
- Breast implants may affect your ability to breast feed, either by reducing or eliminating milk production.
Factors to consider specifically about silicone gel-filled breast implants include:
- If your silicone gel-filled breast implant ruptures, you may have no symptoms. This is called a silent rupture because, most of the time, neither you nor your doctor will know that your implant has ruptured.
- The best way to determine whether or not your silicone gel-filled implant has ruptured is with an MRI examination. You should have your first MRI three years after your implant surgery and every two years thereafter.
- Over your lifetime, the cost of MRI screening may exceed the cost of your initial surgery. This cost may not be covered by medical insurance.
12. What are "gummy bear" gel breast implants?
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).
13. What guidance does FDA provide to the companies that make breast implants?
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).
14. What was the basis for FDA's decisions to approve silicone gel-filled breast implants made by Allergan and Mentor?
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:
- a thorough review of the companies' Core Studies, including three years of data for Mentor and fours years of data for Allergan
- a thorough review of the companies' other clinical information, such as data from the Adjunct Studies (open access studies for reconstruction and revision patients), and international studies
- a thorough review of the companies' laboratory testing data
- a thorough review of the published scientific literature on silicone gel-filled breast implants
- inspections of the manufacturing facilities of both companies to ensure that the implants will be manufactured according to the Quality System Regulations (http://www.fda.gov/cdrh/humfac/frqsr.html)
- deliberations of the October 2003 and April 2005 Advisory Panels
- the laws regulating medical devices.
15. Who can get Mentor and Allergan silicone gel-filled breast implants?
The Mentor and Allergan (formerly Inamed) implants were approved for:
- Breast reconstruction in women of any age. Breast reconstruction includes:
- primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly; and
- revision-reconstruction to correct or improve the result of breast reconstruction surgery.
- Breast augmentation in women 22 years or older. Breast augmentation includes:
- primary augmentation to increase the breast size; and
- revision-augmentation to correct or improve the result of breast augmentation surgery.
16. What were the most frequent complications seen in the Core Studies for the Allergan and Mentor silicone gel-filled breast implants?
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.
17. What did the Core Studies show regarding the rate of rupture and the consequences of rupture?
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).
- For the Mentor Core Study, all reported ruptures were from patients in the MRI cohort. The rupture rates were 0.5% for primary augmentation, 7.7% for revision-augmentation, 0.9% for primary reconstruction, and 0% for revision-reconstruction through 3 years. There were 8 ruptured/suspected ruptured implants in 6 patients through 3 years. Two of the implants were explanted and confirmed to be ruptured; the remaining 6 were considered suspected ruptures based on MRI evaluation. Of the 8 ruptured/suspected ruptured implants, 4 showed intracapsular gel and 4 showed extracapsular gel. There were no cases of migrated gel.
- For the Allergan (formerly Inamed) Core Study, the reported ruptures were from patients in both the MRI and non-MRI cohorts. The rupture rates in the MRI cohort were 2.7% for primary augmentation, 4.0% for revision-augmentation, 0% for primary reconstruction, and 0% for revision-reconstruction through 4 years. For the non-MRI cohort, rupture was reported in 1 primary augmentation, 1 revision-augmentation, 0 primary reconstruction, and 1 revision-reconstruction patient. Across all patients in the study, t here were 9 ruptured/suspected ruptured implants in 9 patients through 4 years. Five of the implants were explanted and confirmed to have ruptured; the remaining 4 were considered suspected ruptures based on physical or MRI evaluation. All 9 ruptured/suspected ruptured implants showed intracapsular gel, and one intracapsular gel progressed into an extracapsular gel following exploratory surgery to confirm the rupture. There were no cases of migrated gel.
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.
18. What conditions of approval did FDA place on these implants?
FDA is requiring each company to do the following:
- Continue its Core Study until all patients have completed their 10-year evaluation in order to assess the long-term clinical performance of its product. This involves:
- collecting data via annual physician follow-up evaluations
- giving all patients MRIs every other year
- evaluating all patients whose breast implants were removed without replacement through 10 years.
- Conduct a separate 10-year large post-approval study that will:
- involve a large number of silicone gel-filled breast implant patients (approximately 40,000)
- involve a control group of saline-filled breast implant patients
- provide information about certain endpoints: local complications; rates of connective tissue disease and its signs and symptoms; rates of neurological disease and its signs and symptoms; potential effects on offspring of women with breast implants; potential effects on reproduction and lactation; rates of cancer; rates of suicide; potential interference of breast implants with mammography; and patient compliance with MRI recommendation and rupture rates
- survey patients annually using web, mail, or telephone questionnaires
- have physician evaluations at years 1, 4-6, and 9-10 for Mentor and years 1, 4, and 10 for Allergan (formerly Inamed) to collect local complication data.
- Continue its laboratory studies to continue to further characterize the modes and causes of failure of explanted (removed) devices over a 10-year period.
- Have an independent group conduct a focus group study of the format and content of the approved patient labeling.
- Distribute approved patient labeling to women considering silicone gel-filled breast implants as part of a formal informed decision process, and monitor the process to ensure that patients are being informed of the risks and benefits.
- Stop new patient enrollment into the Adjunct Studies and continue to follow all currently-enrolled patients through the final 5-year study timepoint.
- require participation in the company's physician training program for physician access to the product
- Comply with FDA's requirements for tracking these devices from their manufacture through the distribution chain to implantation. The purpose of mandatory device tracking is to ensure that companies can promptly locate devices in commercial distribution as well as those that have been implanted. Tracking information may be used to facilitate notifications and recalls ordered by FDA in the case of serious risks to health presented by the devices.
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.
19. If silicone gel-filled breast implants are safe, why is FDA requiring such large post-approval studies?
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.
20. What if the post-approval studies uncover unexpected problems?
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.
21. How will FDA ensure that Allergan and Mentor complete their post-approval studies?
To assure that Mentor and Allergan (formerly Inamed) complete these studies, FDA will:
- Track the post-approval studies, using a new electronic tracking system
- Provide guidance on how and when companies should report the status of their post-approval studies
- Post the status of the studies on our website to help keep the public informed
- Hold open public Panel meetings on the status of the conditions of approval five and 10 years after approval, as well as any other time FDA decides is necessary (e.g., if significant new information from the post-approval studies becomes available)