On Wednesday, March 20, 2019, the United States Food and Drug Administration (FDA) sent letters of warning to two manufacturers for premarket approval orders, and the companies are required to perform studies after approval to ensure that the implants are safe in the long term. Manufacturers are also required to inform the public of the potential safety risks associated with breast implants filled with silicone gel.

Who Received Warnings from the FDA?

The companies that received the warning letters from the FDA were Mentor World Wide LLC, from Irvine, California, and Sientra, Inc., which is from Santa Barbara, also in California. All manufacturers who produce breast implants made of silicone are required to conduct additional studies after approval on the potential risks and safety of the breast implants for the long term that prior trials could not answer.

The FDA’s Mission

Scott Gottlieb, M.D., the FDA’s Commissioner, stated that post-approval requirements are essential to ensure both the effectiveness and safety of medical products the organization regulates. He said he and his colleagues would continue to hold manufacturers responsible if they don’t meet those obligations. He added that the warning letters were sent to the manufacturers in question because they provided poor data, had low recruitment and low follow-up rates in the studies they performed after approval. Gottlieb pointed out that these studies and other surveillance tools are important because they allow the FDA to ensure that medical products and devices are safe for patients.

Why Was Mentor Warned?

In its warning letter to Mentor Worldwide, LLC (Mentor), the FDA made note of a few serious problems in the manufacturer’s post-approval study for the MemoryShape breast implants. The implants, which were first approved by the FDA in 2013, had an issue with Mentor failing to enroll the required number of participants in its study. In addition, the FDA notified the manufacturer of the inconsistencies in its study, such as excluding the race and ethnicity information of participants. Although the FDA made the conclusion that the post-approval study progress was adequate at the time, it nonetheless chose to inform Mentor of its concerns regarding these issues.

According to the FDA, the fact that Mentor failed to address the issues and comply with the requirements of the post-approval study is a violation of the pre-market approval order.

Why was Sientra Warned?

The FDA sent a warning letter to Sientra, Inc. (Sientra) after it noted a serious problem in its post-approval study for the Silicone Gel Breast Implants, which were originally approved in 2013. According to the FDA, Sientra’s follow-up rates with patients were poor. At this time, the manufacturer has reported a follow-up rate of only 61 percent, which is lower than what is considered acceptable. After the company’s most recent study report, the FDA notified it that the progress it reported with its study was inadequate due to the low rate of follow-ups. It noted that Sientra’s failure to keep up with the appropriate follow-up rates with participants in its post-approval study is a violation of the requirements for its pre-market approval order.

After issuing the warning letters, the FDA requested a response from each manufacturer within 15 business days. The companies were also requested to include details on how they would correct their respective violations. However, the FDA can take action against both manufacturers for failing to comply with the requirements of their post-approval orders and even pursue criminal and civil action if needed.

Putting Patient Safety First

The actions the FDA has taken are part of its commitment to ensuring that patients receive access to medical devices that are safe and effective. Per the Medical Device Safety Action Plan, the agency remains committed to making it easier to address any safety issues of devices that have received pre-market approval and to ensure that manufacturers follow all requirements to ensure their products are safe once they are ready to reach the market. In recent years, the FDA has issued numerous warning letters to any and all manufacturers that fail to meet adequate standards for postmarked study requirements.

Health care professionals and consumers alike are urged to report any adverse reactions or events from silicone breast implants to the FDA’s MedWatch Adverse Event Reporting program. All reports are carefully monitored by the FDA, which takes whatever action is necessary to ensure the safety of all medical devices on the market.

Cases in which medical devices cause injury to patients are what the FDA is attempting to avoid, however they can happen even if manufacturers comply with the requirements set.

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