FDA issues warning letters to breast implant manufacturers
The FDA issued warning letters to two breast implant manufacturers the agency contends have failed to comply with regulatory requirements.
The agency sent a letter to Allergan citing the company for failure to comply with requirements to conduct post-approval studies to assess the long-term safety and risks of two types of implants the company voluntarily recalled last year due to concerns about elevated risk for breast implant-associated anaplastic large cell lymphoma.
The FDA also sent a warning letter to Ideal Implant Inc., citing the company for failure to comply with manufacturing practice requirements and adverse event reporting requirements following an inspection performed earlier this year.
Allergan warning letter
Manufacturers of approved silicone gel-filled breast implants are required to conduct post-approval studies that provide additional insights into the long-term effectiveness and safety of their products that premarket clinical trials were not designed to yield.
Even in cases when a breast implant has been voluntarily recalled, manufacturers typically must comply with post-approval requirements to ensure long-term outcomes assessments for patients already implanted with these devices, according to the FDA.
In its letter, the FDA noted serious deficiencies in Allergan’s post-approval study to evaluate its Natrelle Silicone Gel-Filled Breast Implants and its Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants.
“The FDA imposes post-approval requirements because they are an important tool for ensuring the safety and effectiveness of the medical devices we regulate,” Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in a press release. “The agency has been diligently tracking post-approval studies as part of our ongoing efforts to evaluate, understand and provide updates to the public on breast implant safety and risks.
“Post-approval studies are especially important to inform our understanding of the long-term potential risks associated with Allergan’s implants, including the models that have since been recalled from the market due to increased risk [for] breast implant-associated anaplastic large cell lymphoma,” Ashar added. “The manufacturer’s low recruitment and low follow-up rates for these devices is unacceptable. The FDA will continue to hold manufacturers accountable if they fail to fulfill their obligations.”
The FDA requested a response from Allergan within 15 business days and asked the company to provide details about how it will correct the violations.
In response to a request from the FDA, Allergan last summer recalled specific models of its Biocell textured breast implant products due to a potential risk for breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
An FDA analysis showed the risk for BIA-ALCL with Allergan Biocell textured implants is about six times greater than the risk with textured implants from other manufacturers marketing their products in the United States.
Textured implants are less commonly used in the United States than other countries, and macro-textured implants — the type manufactured by Allergan — account for less than 5% of all breast implants sold in the United States.
FDA has encouraged reporting of all BIA-ALCL cases, and it has monitored reports in scientific literature and databases, including external patient registries.
As of last summer, the FDA reported 573 unique cases of BIA-ALCL and 33 patient deaths worldwide.
The majority (83%; n = 481) of identified BIA-ALCL cases had been attributed to Allergan implants, according to the FDA. The manufacturer of the implant in place at the time of BIA-ALCL diagnosis had been identified for 13 of the 33 patients who died. In 12 of those 13 cases, patients were confirmed to have had an Allergan breast implant, according to the FDA.
Ideal Implant warning letter
Manufacturers of approved silicone gel-filled breast implants also must adhere to quality system regulations, including compliance with “applicable current good manufacturing practice requirements,” according to the FDA.
They also must report certain device-related adverse events and product problems under terms of the Medical Device Reporting regulation.
"Quality system inspections are a way for the FDA to determine if a manufacturer’s activities and procedures, conducted during and after the manufacturing of a device, comply with applicable regulations,” Ashar said. “When these regulations are followed, it results in safer products for patients.
During an inspection of the Ideal Implant facility in January and February, FDA inspectors observed potential violations of the Federal Food, Drug and Cosmetic Act.
The warning letter cited failure to maintain proper files for device complaints the manufacturer received from customers, failure to establish and maintain appropriate procedures for implementing corrective and preventive actions, and failure to establish and maintain adequate criteria for testing finished devices.
FDA inspectors also determined products were misbranded because the company failed to provide timely reports to the FDA of device malfunctions that could result in death or serious injury.
Ideal Implant responded to the list of observations inspectors provided to the company but most corrective actions it took were not adequate, Ashar said.
“To protect patients, the company should now take additional action to make sure these issues are properly addressed,” Ashar said. “Addressing quality system and medical device reporting violations helps ensure patient safety, which is our top priority.”
The FDA requested a response from Ideal Implant within 15 business days about how the company will correct the violations.