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FDA Warns Breast Implant Manufacturers

  • March 25, 2019
  • KBA Attorneys
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Two breast implant manufacturers were recently issued warning letters from the U.S. Food and Drug Administration (FDA) because they did not comply with the requirements stated in their premarket approval orders. The manufacturers agreed to conduct post-approval studies. The information from the post-approval studies was intended to be used in determining all risks and safety associated with the silicone gel-filled breast implants for the long-term.


Sientra Inc. (Santa Barbara, California) and Mentor Worldwide (Irvine, California) were given the FDA warning letters. It is required by all manufacturers of approved silicone gel-filled breast implants to provide post-approval studies. These studies are essential for determining the effectiveness and safety of such products. They are used to provide information for scientific questions concerning their potential risks and safety. These studies are designed to provide information about premarket clinical trials conducted by the breast implant manufacturer.

The FDA is determined to hold manufacturers accountable should they not meet their agreed-upon obligations. Making certain medical products regulated by the FDA safe and effective depends on companies meeting their post-approval requirements. The warnings issued by the FDA to these manufacturers were the result of their low recruitment as well as the poor data they provided. They also had insufficient follow-up rates in their post-approval studies, which were required. The FDA tells all manufacturers they are obligated to meet their specified study requirements. This is a way to make certain there is a long-term collection of data available to be used for long-term patient safety. There are surveillance tools that enable the FDA to make sure certain medical devices are safe. These tools include post-approval studies, registries, adverse event reports as well as scientific literature and more.

Serious Deficiencies

The FDA warning letter sent to Mentor Worldwide LLC concerned its Memory Shape breast implants and the many significant deficiencies in the manufacturer’s post-approval study concerning this product. The breast implant was initially approved in 2013. The FDA letter also mentioned that Mentor Worldwide LLC did not have the necessary number of patients involved in their study. The study provided to the FDA by the manufacturer contained serious data inconsistencies such as substandard patient accounting as well as missing ethnicity and race data. The FDA reviewed a number of interim study reports provided by the manufacturer. It appeared at the time of these reviews that adequate progress was being made. Mentor Worldwide LLC was notified by the FDA of its concerns involving follow-up rates, patient enrollment, data inconsistencies and more. The failure of this manufacturer to address concerns and not meet the requirements for its post-approval study is a serious pre-market order violation.

Poor Follow-Up

Sientra Inc. received a warning letter from the FDA because of a serious deficiency in its Silicone Gel Breast Implant post-approval study. The follow-up rates with its patients were considered very poor. Sientra Inc. has a reported follow-up rate of less than 62 percent. This is well below the FDA’s follow-up rate. The FDA response was based on the manufacturer being notified that its study progress was unacceptable due to substandard follow-up rates. Sientra Inc. did not address these concerns or comply with post-approval study requirements. This is a violation of the manufacturer’s pre-market approval order.

FDA Action

Both of these manufacturers were requested by the FDA to respond to the warning letters they were issued within 15 business days. Their responses should provide a detailed explanation concerning how they intend to correct the identified violations. Should either of these manufacturers fail to comply, the FDA may have no choice but to take action. This could include the FDA pursuing all civil penalties and applicable criminal penalties. Taking these actions is part of the FDA’s continuing commitment to its public health mission. The FDA has established a Medical Device Safety Action Plan designed to modernize and streamline how the agency deals with post-market actions. The plan will efficiently address device safety issues, making responses to any type of risk more effective. This will include taking immediate action should the post-market studies provided by a manufacturer not be in compliance with study requirements. Many manufacturers have been issued warning letters by the FDA in recent years. These were sent when the manufacturers did not properly meet the requirements for post-market studies. The FDA is committed to being more aggressive against a lack of compliance by any manufacturer.

Additional Steps

The FDA has taken additional steps to make sure it is properly monitoring the risks and safety of breast implants. The organization’s staff is working with the Plastic Surgeons Foundation as well as the American Society of Plastic Surgeons to create a patient registry so it can obtain real-world data about patients who have a verified diagnosis of Anaplastic Large Cell Lymphoma (BIA-ALCL). This registry and its collected data have helped provide a clearer understanding of BIA-ALCL.

National Breast Implant Registry (NBIR)

The NBIR has been created from the efforts of the FDA to work with various stakeholders. It has been designed to provide a platform for real-world data collection concerning the performance and safety of breast implants. The registry has been newly launched and will provide even more information collected on post-approval studies concerning breast implants and long-term safety. This is going to increase knowledge concerning long-term breast implant risks.

Breast Implants Linked to Cancer

Some breast implants have been linked to a type of cancer called breast implant-associated anaplastic large cell lymphoma. It is a rare form of cancer of the immune system. White blood cells are designed to fight infection in the body. This cancer causes them to grow in an uncontrolled way. It can also cause a type of T-cell lymphoma that builds up in different body parts, including lymph nodes.

FDA Commitment

When it comes to breast implant effectiveness and safety, the FDA remains committed to maintaining public dialogue, as well as transparency and scientific discussion. Consumers, as well as health care professionals, are encouraged to contact the FDA’s MedWatch Adverse Event Reporting Program and report any adverse events associated with breast implants. All of these reports are monitored by the FDA. The organization will take any action it believes is necessary to make certain medical products in the marketplace safe and risk-free.

Contact a Personal Injury Lawyer

Should anyone believe they have been harmed by a defective breast implant, they may want to contact KBA Attorneys. Our experienced product liability lawyers are able to analyze the facts of a breast implant lawsuit and protect the rights of a victim. We know what is necessary to get victims of defective medical products fair compensation for any type of loss they experience.


York, Mark. “AN EMERGING LITIGATION? “Breast Implants Round II””, Mass Tort Nexus, https://www.masstortnexus.com/News/4365/AN-EMERGING-LITIGATION–%E2%80%9CBreast-Implants-Round-II%E2%80%9D. Accessed March 22, 2019.

FDA. “Mentor Worldwide LLC & Acclarent 3/18/19”, U.S. Department of Health and Human Services, https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm633710.htm. Accessed March 22, 2019.

FDA. “Sientra Inc 3/18/19”,U.S. Department of Health and Human Services, https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm633719.htm. Accessed March 22,2019.