Are Integra’s breast reconstruction aspirations doomed?
An FDA General and Plastic Surgery Advisory Group recently shot down Integra LifeSciences’ SurgiMend Mesh for the specific indication of breast reconstruction, even though the device has been used in breast reconstruction for over a decade under a 510 (k) clearance.
However, all hope may not be lost. When calling for Integra’s third quarter earnings, the company’s management team expressed confidence that FDA approval for post-mastectomy breast reconstruction is still within reach.
A specific indication for breast reconstruction – which no device currently has – would position Integra in a $ 500 million market that is expected to reach $ 900 million by fiscal 2025. The SurgiMend device is currently indicated to be used as soft tissue strengthening where weakness exists, including within plastic and reconstructive surgery.
Glenn Coleman, executive vice president and chief operating officer of Integra, said the Oct. 20 expert panel meeting was an important review of the clinical section of the pre-release approval application. Integra’s market (PMA), and he called it a âone-stopâ in the broader FDA Product Review and Approval Process. He explained that Integra worked with the FDA to design a statistical analysis plan for data from the Mastectomy Reconstruction Outcomes Consortium (MROC) study, which was a large, multi-center study that looked at outcomes for thousands of patients. having undergone breast reconstruction.
“This analysis demonstrated that the results with SurgiMend PRS (plastic and reconstructive surgery) and breast reconstruction using post-mastectomy implants are superior to the results of such procedures when no acellular dermal matrix is ââused,” said Coleman on the results call. âNonetheless, we have always recognized that there are limitations in the data from the MROC study, and this was reflected in the results of the panel’s split votes regarding safety, efficacy and whether the benefits. outweigh the risks. We value the ideas of the FDA panel members and the discussion regarding our PMA. “
The SurgiMend device is primarily composed of a matrix of intact extracellular collagen fibers from fetal bovine dermis. Biological meshes are biodegradable and are formed by processing and sterilizing human, cow (bovine) or pig tissue to remove cells, resulting in an acellular dermal matrix (ADM) of collagen. Over the past decade, surgeons have begun to use surgical meshes to facilitate these reconstructive procedures, and ADM meshes are now used in the majority of implant-based breast reconstruction procedures in the United States, according to the summary of the PMA. The FDA has not authorized or approved any surgical mesh device – whether synthetic, derived from animal collagen, or derived from human collagen – specifically indicated for breast reconstruction.
Coleman said there is an urgent clinical need for an FDA-approved ADM to help restore women’s quality of life after breast reconstruction.
âWe look forward to working with the FDA in the coming months as the agency completes its review of our PMA submission, and we believe that the real-world clinical evidence supports the approval,â he said.
One of the interesting things about the MROC data is that the FDA had access to data from anonymized patient-level MROC studies, but the company was unable to see the real-world evidence prior to the meeting. of the advisory committee. Coleman noted that the FDA has stated that all acellular dermal matrix (ADM) products, including human ADM products, require a PMA. To date, Integra is the only company to file a PMA for an indication for breast reconstruction. He said the clinical data that is part of the company’s PMA is in part based on the MROC study, which he says is considered real high-quality data.
Coleman said that because the company recognizes that there are certain limitations to the data, Integra is working with the FDA to design a post-approval study to supplement the existing data.
Although the panel voted against the recommendation to approve the SurgiMend device for the indication of breast reconstruction, the agency will make the final decision. While the FDA rarely disagrees with the panel’s recommendations, it has happened before. A study published in 2019 sheds light on how often the FDA goes against the panel’s recommendations and some of the circumstances that lead to a mismatch between the committee’s vote and the FDA’s final decision. Click here to learn more about this study.
âTheir recommendation is really advisory,â Coleman said of the advisory board. “And so we will continue to move forward with the work underway here. The vote of this panel obviously does not change the current practices taking place among surgeons. And there is still an urgent clinical need for a Matrix. Acellular dermal skin approved by the FDA to help restore the quality of life of women after breast reconstruction. We are therefore confident that the existing clinical evidence supports the approval. And of course, we remain focused on the mission of improving outcomes for patients with breast cancer.
This PMA process is taking place at the same time as the company is experiencing a major change in leadership. Peter Arduini is leaving his role as CEO of Integra by the end of the year to become CEO of GE Healthcare. As MD + DI Recently reported, Arduini will be replaced by healthcare industry veteran Jan De Witte.
âI think the other aspect about this that is really important is the fact that we strongly believe that SurgiMend has unique characteristics that no other product has, including a human-based cadaver product,â said Arduini during the call on the results. “And it’s [three] things. It is an incredible strength that he has. And as the volume of procedures evolves into new procedures with broader coverage, we believe it will be the leading product. Second, our process of cellularization of its acceptance, its low rate of bodily rejection is unparalleled. And the third is its revascularization characteristics, which again becomes very, very important if you want us to really be an integrated part of the body. And so these are the three things that we keep as the beacons related to what Glenn said, which is fighting for women to have the right to have a post-mastectomy product and reconstruction. So that’s a very important part of the plan, and it’s a long journey, but we think we’re on the right track here. “